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Trial record 10 of 12 for:    gadoteridol

Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D) (RABIT1D)

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ClinicalTrials.gov Identifier: NCT01019486
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Coronary Artery Disease
Type 1 Diabetes Mellitus
Interventions Drug: Regadenoson myocardial perfusion imaging
Drug: Regadenoson MRI myocardial blood flow
Enrollment 26
Recruitment Details Recruitment began 7-22-2010 and ended 12-30-2011. We recruited from subjects of the Coronary Artery Calcification in Type 1 (CACTI) Diabetes Study (R01HL61753) included type 1 diabetic patients (duration, diabetes 10 yrs) and non-diabetic controls (spouses or friends of these diabetic patients, focusing on individuals completing 6-yr follow-up..
Pre-assignment Details Twenty-five subjects planned with 26 consented with one excluded with significant renal disease. A total of 25 myocardial perfusion imaging studies; 23 MRI myocardial blood flow (MBF) MRI studies performed of which 23 yielded analyzable. A total of 3 subject meet criteria to proceed to invasive coronary flow reserve measurements
Arm/Group Title Non Diabetic Controls Type 1 Diabetes Low Risk Group Type 1 Diabetes High Risk Group
Hide Arm/Group Description Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy) Subjects with T1DM for at least 10 years and CAC < 100 Subjects with T1DM for at least 10 years and CAC > or = 100
Period Title: Overall Study
Started 5 5 16
Completed 4 4 15
Not Completed 1 1 1
Reason Not Completed
Withdrawal by Subject             1             1             1
Arm/Group Title Non Diabetic Controls Type 1 Diabetes Low Risk Group Type 1 Diabetes High Risk Group Total
Hide Arm/Group Description Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy) Subjects with T1DM for at least 10 years and CAC < 100 Subjects with T1DM for at least 10 years and CAC > or = 100 Total of all reporting groups
Overall Number of Baseline Participants 4 4 15 23
Hide Baseline Analysis Population Description
mean age value with standard deviation.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 15 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
13
  86.7%
21
  91.3%
>=65 years
0
   0.0%
0
   0.0%
2
  13.3%
2
   8.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 15 participants 23 participants
62.0  (1.6) 59.3  (10.1) 57.3  (5.2) 59.8  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 15 participants 23 participants
Female
1
  25.0%
0
   0.0%
4
  26.7%
5
  21.7%
Male
3
  75.0%
4
 100.0%
11
  73.3%
18
  78.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 15 participants 23 participants
4 4 15 23
1.Primary Outcome
Title Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects.
Hide Description Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Determine the MBF obtained from cardiac MRI from 6 regions of the mid-ventricular LV myocardium and a ratio between stress/rest myocardial blood flow ratio. Differences between group were compared using a unpaired "t" test analyzed for: control(Con) vs T1DM low risk; Con. vs T1DM High Risk; and T1DM low vs high risk.
Arm/Group Title Non Diabetic Controls Type 1 Diabetes Low Risk Group Type 1 Diabetes High Risk Group
Hide Arm/Group Description:
Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
Subjects with T1DM for at least 10 years and CAC < 100
Subjects with T1DM for at least 10 years and CAC > or = 100
Overall Number of Participants Analyzed 4 4 15
Mean (Standard Deviation)
Unit of Measure: percentage of StressMBF/ Rest MBF
2.19  (0.3) 1.81  (0.6) 1.95  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non Diabetic Controls, Type 1 Diabetes Low Risk Group
Comments Independent Student t test between arms with two tailed analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non Diabetic Controls, Type 1 Diabetes High Risk Group
Comments Independent Student t test between arms with two tailed analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Type 1 Diabetes Low Risk Group, Type 1 Diabetes High Risk Group
Comments Independent Student t test between groups with two-tailed analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress.
Hide Description Regional coronary blood flow reserve (CFR) in a target artery (defined on MPI study) compared to flow in a less diseased atherosclerotic vessel following vasodilator response to intravenously administered regadenoson.
Time Frame within 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 individuals met the prescribed perfusion defect on MPI study to proceed to the CFR measurement arm of the study. Therefore numbers were too small for statistical comparison and only mean value and standard deviation of the flow ratio(CFR measurements) are reported..
Arm/Group Title Abnormal MPI Study
Hide Arm/Group Description:
These subjects demonstrated abnormal radionuclide myocardial perfusion imaging studies with perfusion defects in response to regadenoson stress. The perfusion defect qualified the subject to participated in invasive CFR measurements. Coronary arteries within the region of the perfusion defect were cannulated for CFR measurements. Flow measurements were performed in the 2 normal vessels and the abnormal vessel both at rest and following regadenoson administration to calculated CFR values..
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: CFR ratio
1.5  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abnormal MPI Study
Comments No analysis was performed due to limited data.
Type of Statistical Test Non-Inferiority or Equivalence
Comments If sufficient subjects were enrolled then it would be expected that the MRI measurement of myocardial blood flow MBF would similar or equivalent to the invasively measured CFR in response to intravenous regadenoson administration.
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter None insufficient data
Estimated Value 2.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Myocardial Perfusion Index
Hide Description Myocardial perfusion indices radionuclide stress and rest images and were obtained from 6 regions within the mid ventricular LV short axis slice. Each was corrected for decay and standardized to a 30 mCi administered dose for each part of a two day study.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non Diabetic Controls Type 1 Diabetes Low Risk Group Type 1 Diabetes High Risk Group
Hide Arm/Group Description:
Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
Subjects with T1DM for at least 10 years and CAC < 100
Subjects with T1DM for at least 10 years and CAC > or = 100
Overall Number of Participants Analyzed 4 4 15
Mean (Standard Deviation)
Unit of Measure: percentage of Ratio Stress/ rest counts
1.09  (.19) 1.4  (.60) 1.12  (.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non Diabetic Controls, Type 1 Diabetes Low Risk Group, Type 1 Diabetes High Risk Group
Comments Comparison between groups using a two-tailed Student t test
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Event were recorded over the 18 months of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non Diabetic Controls Type 1 Diabetes Low Risk Group Type 1 Diabetes High Risk Group
Hide Arm/Group Description Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy) Subjects with T1DM for at least 10 years and CAC < 100 Subjects with T1DM for at least 10 years and CAC > or = 100
All-Cause Mortality
Non Diabetic Controls Type 1 Diabetes Low Risk Group Type 1 Diabetes High Risk Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Non Diabetic Controls Type 1 Diabetes Low Risk Group Type 1 Diabetes High Risk Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Non Diabetic Controls Type 1 Diabetes Low Risk Group Type 1 Diabetes High Risk Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   0/16 (0.00%) 
3 subject had visual perfusion defects, leading to a small % of individuals being referred for invasive CFR measurements. MBF values were less than reported, either from microvascular disease in T1D subjects or the order of rest first then stress.
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
Layout table for Results Point of Contact information
Name/Title: Robert A. Quaife M.D.
Organization: University of Colorado, Denver
Phone: 720-848-6562
EMail: robert.quaife@ucdenver.edu
Publications:
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01019486     History of Changes
Other Study ID Numbers: 09-0426
First Submitted: November 23, 2009
First Posted: November 25, 2009
Results First Submitted: January 2, 2013
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015