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Autologous Stem Cells for Cardiac Angiogenesis (FOCUS HF)

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ClinicalTrials.gov Identifier: NCT00203203
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 30, 2013
Last Update Posted : November 28, 2016
Sponsor:
Collaborator:
CHI St. Luke's Health, Texas
Information provided by (Responsible Party):
Emerson Perin, MD, PhD, Texas Heart Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Ischemic Cardiomyopathy
Interventions Device: Intramyocardial Injection of stem cells via NOGA Mapping
Other: Control, then Stem Cell Therapy
Enrollment 30
Recruitment Details Thirty patients were recruited between 4/14/04 and 2/8/07 from outpatient cardiology clinics.
Pre-assignment Details  
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Period Title: Overall Study
Started 10 20
Completed 9 20
Not Completed 1 0
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy Total
Hide Arm/Group Description

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping. Total of all reporting groups
Overall Number of Baseline Participants 10 20 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
14
  70.0%
24
  80.0%
>=65 years
0
   0.0%
6
  30.0%
6
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 20 participants 30 participants
56.3  (8.6) 60.5  (6.4) 60.0  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Female
3
  30.0%
5
  25.0%
8
  26.7%
Male
7
  70.0%
15
  75.0%
22
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 20 participants 30 participants
10 20 30
1.Primary Outcome
Title Safety of Autologous-bone-marrow Injections
Hide Description Safety of cell injections was assessed by reviewing adverse events at 3 time points: (1) up to 2 weeks post-procedure), (2) 3 months post-procedure, and (3) at 6 months post-procedure. Major adverse events were adjudicated (hospitalization, arrhythmia, exacerbation of congestive HF [CHF], acute coronary syndrome, myocardial infarction, stroke, or death).
Time Frame up to 2 weeks post-procedure, 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Adverse events which occurred in all participants.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Measure Type: Number
Unit of Measure: participants
post-procedural transient left bundle branch block 1 1
Post-procedure pericardial effusion (nonsignifiant 0 1
Post-procedure transient fever 1 0
Fever (6 months) 2 0
Sustained ventricular arrhythmias (6 months) 0 0
Discharge implantable cardiac defibrillator (6 mo) 0 1
Exacerbation of congestive heart failure (6 mo) 1 2
Myocardial infarction (6 months) 0 0
Death (6 months) 0 0
2.Secondary Outcome
Title Canadian Cardiovascular (CCS) Angina Score
Hide Description

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Canadian Cardiovascular (CCS) Angina Score which indicates discomfort from angina (chest pain).

Class I- Angina only during strenuous or prolonged activity Class II- Slight limitation, with angina only during vigorous physical activity Class III- Symptoms with everyday living activities (moderate limitation) Class IV- Inability to perform any activity without angina or angina at rest (severe limitation)

Time Frame baseline, 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
CCS baseline 3  (0.3) 3  (0.2)
CCS 3 months 2.2  (0.3) 2.1  (0.2)
CCS 6 months 2.6  (0.3) 1.8  (0.2)
3.Secondary Outcome
Title New York Heart Association (NYHA)Classification
Hide Description

Clinical and functional assessment in endstage ischemic cardiomyopathy patients using New York Heart Association (NYHA)Classification and indicates extent of heart failure based on limitations in physical activity.

Class I- No symptoms/limitation in ordinary physical activity (shortness of breath when walking, etc) Class II-Mild symptoms/slight limitation during ordinary activity Class III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV- Severe limitations in activity/experiences symptoms while at rest (bedbound)

Time Frame baseline, 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: NYHA Functional Class
NYHA Baseline 2.6  (0.3) 2.3  (0.2)
NYHA 3 months 1.9  (0.3) 2  (0.2)
NYHA 6 months 2.4  (0.3) 1.8  (0.2)
4.Secondary Outcome
Title Myocardial Oxygen Consumption (MVO2)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Myocardial Oxygen Consumption (MVO2)which is the amount of oxygen used by the heart muscle and is indicative of heart muscle function. Normal value is 15.5 Volume %. Measured as milliliters (ml) oxygen per kilogram (kg) body weight per minute.
Time Frame baseline, 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: Percentage of Oxygen Saturation
MVO2 (ml/kg per min) baseline 14.8  (0.8) 14.7  (0.6)
MVO2 (ml/kg per min) 3 months 15.7  (0.8) 15.5  (0.6)
MVO2 (ml/kg per min) 6 months 15.6  (0.9) 15.8  (0.6)
5.Secondary Outcome
Title Echocardiography (EF)Percent (%)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography measures ejection fraction(EF)as a percentage(%) of blood leaving the heart with each beat or contraction. It can provide information concerning structural characteristics and blood flow in the heart and blood vessels. A normal heart pumps 50-75% of the blood with each contraction.
Time Frame baseline, 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: Ejection Fraction %
Echocardiography EF (%) baseline 39  (9.1) 37  (10.6)
Echocardiography EF (%) 3 months 41  (5.4) 38  (5.4)
Echocardiography EF (%) 6 months 42  (5.4) 40  (5.4)
6.Secondary Outcome
Title Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 Slope)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Minute Ventilation- Carbon Dioxide Production Relationship (VE/VCO2 slope)measure during a cardiopulmonary exercise test has a high prognostic value for survival in heart failure patients. Normal VE (milliliters per minute)/VCO2 (milliliters per minute)equals 25.
Time Frame baseline and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: VE/VCO2 slope
VE/VCO2 baseline 29.8  (8) 32.7  (6)
VE/VCO2 3 months 32.8  (5) 31.8  (7)
7.Secondary Outcome
Title Echocardiography Wall Motion Score Index (WMSI)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Echocardiography Wall Motion Score Index (WMSI)which allows detection of abnormalities in the heart wall or blood flowing through the heart. Normal contracting Left Ventricle has WMSI of 1. Larger WMSI indicates higher degree of abnormalities (2 for hypokinetic, 3 for akinetic, 4 for dyskinetic, and 5 for aneurysmal). WMSI was calculated as the sum of scores divided by the total number of segments.
Time Frame baseline and 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: Wall Motion Score Index
Wall Motion Score Index (WMSI) baseline 1.7  (0.5) 1.7  (0.5)
Wall Motion Score Index (WMSI) 3 months 1.6  (0.4) 1.7  (0.6)
8.Secondary Outcome
Title Single-photon Emission Computed Tomography (SPECT) Imaging for Left Ventricular Ejection Fraction (LVEF) Percentage (%)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Single-photon emission computed tomography (SPECT) imaging for Left Ventricular Ejection Fraction (LVEF) percentage (%)to determine how well the heart is pumping blood from the left ventricle. Different method for evaluating how much (%) of blood is pumped through heart with each contraction.
Time Frame baseline, 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: Left Ventricular Ejection Fraction (%)
SPECT LVEF (%) baseline 43  (10.4) 41.5  (11.2)
SPECT LVEF (%) 3 months 46.8  (9.5) 43.2  (11.1)
SPECT LVEF (%) 6 months 47.8  (7.5) 44  (13.4)
9.Secondary Outcome
Title Angiography Left Ventricular Ejection Fraction (LVEF) Percent (%)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using angiography left ventricular ejection fraction (LVEF) percent (%) which is an invasive method used to estimate how well the heart is pumping blood through the ventricle and is considered the "gold" standard.
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: Angiography LVEF (%)
Angiography LVEF (%) baseline 40  (3.2) 37.5  (8.2)
Angiography LVEF (%) 6 months 40.9  (8.5) 42  (14.4)
10.Secondary Outcome
Title Left Ventricular End-Diastolic Volume (LVEDV)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Diastolic Volume (LVEDV)which is the volume of blood inside the left ventricle when the heart has completed its filling cycle. The volume of the left ventricle is measured during contraction and relaxation. Normal heart volume inside the left ventricle is about 140 milliliters.
Time Frame baseline, 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: Volume in left ventricle (milliliters)
LVEDV (ml) baseline 132.2  (43.6) 133.2  (53.6)
LVEDV (ml) 3 months 125.7  (46.3) 123.9  (58.2)
LVEDV (ml) 6 months 120.0  (30.9) 123.9  (39.7)
11.Secondary Outcome
Title Left Ventricular End-Systolic Volume (LVESV) (ml)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Left Ventricular End-Systolic Volume (LVESV)when the blood moves from the ventricles to the atria during the contraction cycle. Measured as volume in milliliters (ml). Normal is approximately 60- 65 milliliters.
Time Frame baseline, 3 months and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: ml
LVESV (ml) baseline 81.7  (40.7) 92.9  (50.5)
LVESV (ml) 3 months 74.4  (37) 83.2  (43.2)
LVESV (ml) 6 months 71.8  (27.2) 74  (29.5)
12.Secondary Outcome
Title Endocardial Unipolar Voltages (UPV)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Endocardial Unipolar Voltages (UPV)in millivolts(mV)which may be indicative of scar tissue. Normal is <5.5 mV.
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was analyzed for all participants in control and treated groups.
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: Unipolar voltage (mV)
UPV (mV) baseline 10.2  (4.3) 10.5  (5.1)
UPV (mV) 6 months 10.1  (4.8) 10.8  (5.4)
13.Secondary Outcome
Title Linear Local Shortening (LLS)
Hide Description Clinical and functional assessment in endstage ischemic cardiomyopathy patients using Linear Local Shortening (LLS)which is an indicator of mechanical properties of the heart and measured as a percentage (%)of local contraction.
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description:

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
Overall Number of Participants Analyzed 10 20
Mean (Standard Deviation)
Unit of Measure: percentage of linear local shortening
LLS (%) baseline 12.1  (6.8) 10.5  (7.3)
LLS (%) 6 months 9.1  (6.4) 10.8  (6.8)
Time Frame Adverse event data were collected pre-procedure, during procedure, after procedure, at 1, 2, 4, 6, 8 weeks post procedure and monthly until 1 year post-procedure.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control, Then Stem Cell Therapy Stem Cell Therapy
Hide Arm/Group Description

Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.

At 6 months, subject is offered stem cell therapy.

Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
All-Cause Mortality
Control, Then Stem Cell Therapy Stem Cell Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control, Then Stem Cell Therapy Stem Cell Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/10 (70.00%)      11/20 (55.00%)    
Cardiac disorders     
Chest pain and slightly elevated Troponin I *  0/10 (0.00%)  0 1/20 (5.00%)  2
Elevated troponin,chestpain and fever with episode of cellulitis *  0/10 (0.00%)  0 1/20 (5.00%)  1
Hospitalized for chest pain *  0/10 (0.00%)  0 1/20 (5.00%)  1
Hospitalized for heart failure at one year *  0/10 (0.00%)  0 1/20 (5.00%)  1
Myocardial infarction *  0/10 (0.00%)  0 1/20 (5.00%)  1
Placement of AICD *  2/10 (20.00%)  2 1/20 (5.00%)  1
Pulmonary edema & slightly elevated Troponin I with ablation of atrial fibrillation *  0/10 (0.00%)  0 1/20 (5.00%)  1
Replacement of AICD *  1/10 (10.00%)  1 2/20 (10.00%)  2
Restenosis without symptoms at 6 months, received stent *  0/10 (0.00%)  0 2/20 (10.00%)  2
Troponin I elevation in presence of new onset Atrial fibrillation *  0/10 (0.00%)  0 1/20 (5.00%)  1
bronchitis, decompensated heart failure *  1/10 (10.00%)  1 0/20 (0.00%)  0
decompensated heart failure *  0/10 (0.00%)  0 1/20 (5.00%)  1
elevated Troponin T in presence of bacteremia *  1/10 (10.00%)  1 0/20 (0.00%)  0
supraventricular tachycardia ablation *  0/10 (0.00%)  0 2/20 (10.00%)  2
unstable angina and stent *  1/10 (10.00%)  1 0/20 (0.00%)  0
urosepsis and chest pain *  1/10 (10.00%)  1 0/20 (0.00%)  0
ventricular tachycardia during 6 month F/Ucath requiring cardioversion *  1/10 (10.00%)  1 0/20 (0.00%)  0
Infections and infestations     
False positive culture on processed stem cells at day 5 *  0/10 (0.00%)  0 1/20 (5.00%)  1
Staph aureus septicemia (left sternoclavicular area) leg *  1/10 (10.00%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders     
back pain *  0/10 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders     
Confusion/disorientation *  0/10 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders     
Urosepsis *  1/10 (10.00%)  1 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary edema within 24 hrs of treatment *  1/10 (10.00%)  1 0/20 (0.00%)  0
Upper respiratory infection *  0/10 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Control, Then Stem Cell Therapy Stem Cell Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/10 (90.00%)      18/20 (90.00%)    
Blood and lymphatic system disorders     
anemia *  0/10 (0.00%)  0 2/20 (10.00%)  2
bloody nose *  0/10 (0.00%)  0 1/20 (5.00%)  1
decrease in platelets/ hematocrit *  2/10 (20.00%)  3 0/20 (0.00%)  0
edema, extremity not specified *  1/10 (10.00%)  2 4/20 (20.00%)  7
edema, upper extremities *  0/10 (0.00%)  0 1/20 (5.00%)  1
gout, increased symptoms *  0/10 (0.00%)  0 1/20 (5.00%)  1
scrotal edema/ erythema *  0/10 (0.00%)  0 1/20 (5.00%)  2
swelling/ edema lower extremities *  2/10 (20.00%)  2 10/20 (50.00%)  17
swelling/ edema upper extremity *  0/10 (0.00%)  0 1/20 (5.00%)  1
Cardiac disorders     
changes in cardiac enzymes (CK-MB,BNP,CRP, troponin) *  1/10 (10.00%)  1 5/20 (25.00%)  9
changes in heart rate *  2/10 (20.00%)  3 3/20 (15.00%)  4
chest pain/ increased chest pain *  4/10 (40.00%)  6 16/20 (80.00%)  23
electrocardiogram changes *  0/10 (0.00%)  0 4/20 (20.00%)  17
heart failure *  0/10 (0.00%)  0 2/20 (10.00%)  4
heart palpitations *  2/10 (20.00%)  2 2/20 (10.00%)  2
hypertension *  0/10 (0.00%)  0 6/20 (30.00%)  6
hypotension *  0/10 (0.00%)  0 1/20 (5.00%)  1
myocardial infaction, non-ST elevation *  0/10 (0.00%)  0 1/20 (5.00%)  1
pleuritic chest pain *  0/10 (0.00%)  0 1/20 (5.00%)  1
shortness of breath, lying down *  1/10 (10.00%)  1 1/20 (5.00%)  1
Endocrine disorders     
diabetes uncontrolled *  0/10 (0.00%)  0 1/20 (5.00%)  3
hyperglycermia *  1/10 (10.00%)  1 2/20 (10.00%)  3
hypoglycemia *  0/10 (0.00%)  0 2/20 (10.00%)  2
Eye disorders     
abnormalities/ pain eye *  1/10 (10.00%)  1 1/20 (5.00%)  1
blurred vision *  1/10 (10.00%)  1 0/20 (0.00%)  0
eyes sensitive to light *  1/10 (10.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders     
abdominal bloating *  1/10 (10.00%)  1 2/20 (10.00%)  2
constipation *  0/10 (0.00%)  0 1/20 (5.00%)  1
cramping *  0/10 (0.00%)  0 1/20 (5.00%)  1
diarrhea *  1/10 (10.00%)  1 0/20 (0.00%)  0
digestive problems *  0/10 (0.00%)  0 3/20 (15.00%)  3
gastroespohageal reflux *  0/10 (0.00%)  0 1/20 (5.00%)  1
heartburn *  1/10 (10.00%)  1 0/20 (0.00%)  0
nausea *  2/10 (20.00%)  2 1/20 (5.00%)  1
General disorders     
ICD firing *  0/10 (0.00%)  0 1/20 (5.00%)  1
abnormality on MRI scan *  0/10 (0.00%)  0 1/20 (5.00%)  1
albumin, increase *  1/10 (10.00%)  2 0/20 (0.00%)  0
cold/ congestion *  2/10 (20.00%)  2 5/20 (25.00%)  7
diaphoresis *  0/10 (0.00%)  0 1/20 (5.00%)  1
disorientation *  0/10 (0.00%)  0 1/20 (5.00%)  1
dizziness/ light-headedness *  3/10 (30.00%)  3 5/20 (25.00%)  8
fall/ balance problems *  0/10 (0.00%)  0 3/20 (15.00%)  3
fatigue/ weakness *  2/10 (20.00%)  2 7/20 (35.00%)  11
fever *  3/10 (30.00%)  3 2/20 (10.00%)  3
gum bleeding *  1/10 (10.00%)  1 0/20 (0.00%)  0
headache *  4/10 (40.00%)  4 4/20 (20.00%)  4
hematoma at catheter site *  3/10 (30.00%)  4 3/20 (15.00%)  5
insomnia/ sleep disorders *  0/10 (0.00%)  0 3/20 (15.00%)  3
sinus congestion/ compliant *  2/10 (20.00%)  2 2/20 (10.00%)  6
soreness/ brusing *  0/10 (0.00%)  0 2/20 (10.00%)  2
spider bite *  0/10 (0.00%)  0 1/20 (5.00%)  1
weight gain *  0/10 (0.00%)  0 3/20 (15.00%)  3
Infections and infestations     
abcess tooth *  1/10 (10.00%)  1 1/20 (5.00%)  1
carbuncles on body *  0/10 (0.00%)  0 1/20 (5.00%)  1
cellulitis *  0/10 (0.00%)  0 2/20 (10.00%)  3
chills *  0/10 (0.00%)  0 1/20 (5.00%)  1
influenza/ flu-like symptoms *  2/10 (20.00%)  2 1/20 (5.00%)  1
lesion right foot *  1/10 (10.00%)  1 0/20 (0.00%)  0
shingles *  1/10 (10.00%)  1 0/20 (0.00%)  0
upper respiratory infection *  0/10 (0.00%)  0 3/20 (15.00%)  3
virus *  1/10 (10.00%)  1 1/20 (5.00%)  1
white blood count, elevated *  0/10 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
abcess left sternovascular joint *  1/10 (10.00%)  1 0/20 (0.00%)  0
back/ hip pain *  4/10 (40.00%)  4 9/20 (45.00%)  16
bone fracture *  2/10 (20.00%)  2 0/20 (0.00%)  0
bone pain, extremities *  1/10 (10.00%)  4 3/20 (15.00%)  4
carpel tunnel release *  1/10 (10.00%)  1 0/20 (0.00%)  0
muscle pain/pull *  0/10 (0.00%)  0 3/20 (15.00%)  3
numbness/ tingling in extremities *  1/10 (10.00%)  1 4/20 (20.00%)  9
sciatica *  0/10 (0.00%)  0 1/20 (5.00%)  2
shoulder pain *  1/10 (10.00%)  2 4/20 (20.00%)  4
tremors *  0/10 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders     
slurred speech/ dysphasia *  0/10 (0.00%)  0 2/20 (10.00%)  2
Psychiatric disorders     
anxiety *  0/10 (0.00%)  0 1/20 (5.00%)  1
depression *  0/10 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders     
changes in renal enzymes (BUN, creatinine, chloride) *  1/10 (10.00%)  1 2/20 (10.00%)  2
renal insufficiency/ urinary problems *  1/10 (10.00%)  3 0/20 (0.00%)  0
urinary tract infection *  1/10 (10.00%)  1 1/20 (5.00%)  2
urinary/ bladder problems *  1/10 (10.00%)  1 1/20 (5.00%)  2
Respiratory, thoracic and mediastinal disorders     
bronchitis *  2/10 (20.00%)  2 3/20 (15.00%)  3
chronic obtructive pulmonary disease, increased symptoms *  0/10 (0.00%)  0 1/20 (5.00%)  1
cough *  3/10 (30.00%)  3 3/20 (15.00%)  5
crackles/ wheezes in lungs *  1/10 (10.00%)  1 3/20 (15.00%)  6
probable obstructive sleep apnea *  0/10 (0.00%)  0 1/20 (5.00%)  1
pulmonary edema *  1/10 (10.00%)  1 1/20 (5.00%)  1
shortness of breath/ increased shortness of breath/ difficulty breathing *  4/10 (40.00%)  6 7/20 (35.00%)  9
Skin and subcutaneous tissue disorders     
itching *  0/10 (0.00%)  0 1/20 (5.00%)  1
petechia *  1/10 (10.00%)  1 0/20 (0.00%)  0
psoriasis *  0/10 (0.00%)  0 1/20 (5.00%)  1
skin flushing *  0/10 (0.00%)  0 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
The study is a preliminary study based on a small sample size which limits the statistical rigor of the analysis.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Emerson C. Perin, M.D., Ph.D.
Organization: Texas Heart Institute
Phone: 832-355-9405
Responsible Party: Emerson Perin, MD, PhD, Texas Heart Institute
ClinicalTrials.gov Identifier: NCT00203203     History of Changes
Other Study ID Numbers: HSC-MS-04-141
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: July 6, 2011
Results First Posted: January 30, 2013
Last Update Posted: November 28, 2016