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Trial record 1 of 329 for:    heart disease AND stroke AND California
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Noninvasive Measurement of CO Using Impedance Cardiography in Patients With CHD

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ClinicalTrials.gov Identifier: NCT02326649
Recruitment Status : Completed
First Posted : December 29, 2014
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Christopher Davis, University of California, San Diego

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Congenital Heart Disease
Intervention Device: Physioflow
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SMIC and CMR
Hide Arm/Group Description Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
Period Title: Overall Study
Started 33
Completed 21
Not Completed 12
Arm/Group Title Diagnosis, Age, and Body Size of Subjects
Hide Arm/Group Description Overall
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants
18
(7 to 30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
8
  38.1%
Male
13
  61.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Body Surface Area  
Mean (Full Range)
Unit of measure:  Meters squared
Number Analyzed 21 participants
1.67
(0.8 to 2.2)
1.Primary Outcome
Title Mean Difference in Stroke Volume Between CMR and SMIC
Hide Description Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SMIC and CMR
Hide Arm/Group Description:
Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
Overall Number of Participants Analyzed 21
Mean (95% Confidence Interval)
Unit of Measure: ml
1.7
(-3.1 to 6.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SMIC and CMR
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method paired t-test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SMIC and CMR
Comments Intercept for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.255
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.561
Confidence Interval (2-Sided) 95%
-5.295 to 18.417
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.528
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SMIC and CMR
Comments Heart rate delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.500
Confidence Interval (2-Sided) 95%
-0.395 to 1.395
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.417
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SMIC and CMR
Comments Diastolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.427
Confidence Interval (2-Sided) 95%
-1.081 to 0.227
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.305
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection SMIC and CMR
Comments Systolic BP delta for multilinear regression for difference in stroke volume controlling for difference in heart rate and blood pressure
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.557
Confidence Interval (2-Sided) 95%
-0.411 to 1.526
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.452
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CHD Patients Undergoing Cardiac MRI Without Sedation
Hide Arm/Group Description Physioflow: impedance cardiography instrument that measures cardiac output non-invasively
All-Cause Mortality
CHD Patients Undergoing Cardiac MRI Without Sedation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CHD Patients Undergoing Cardiac MRI Without Sedation
Affected / at Risk (%)
Total   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CHD Patients Undergoing Cardiac MRI Without Sedation
Affected / at Risk (%)
Total   0/33 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Christopher Davis
Organization: UCSD
Phone: 8589665855 ext 5668
Responsible Party: Dr. Christopher Davis, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02326649     History of Changes
Other Study ID Numbers: 140550
First Submitted: December 15, 2014
First Posted: December 29, 2014
Results First Submitted: February 28, 2017
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017