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Trial Outcomes & Findings for Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D) (NCT NCT01019486)

NCT ID: NCT01019486

Last Updated: 2015-12-14

Results Overview

Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

1 month

Results posted on

2015-12-14

Participant Flow

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..

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

Participant milestones

Participant milestones
Measure
Non Diabetic Controls
Subjects with Coronary Artery Calcium (CAC score\> 100 in the CACTI Stdy)
Type 1 Diabetes Low Risk Group
Subjects with T1DM for at least 10 years and CAC \< 100
Type 1 Diabetes High Risk Group
Subjects with T1DM for at least 10 years and CAC \> or = 100
Overall Study
STARTED
5
5
16
Overall Study
COMPLETED
4
4
15
Overall Study
NOT COMPLETED
1
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Non Diabetic Controls
Subjects with Coronary Artery Calcium (CAC score\> 100 in the CACTI Stdy)
Type 1 Diabetes Low Risk Group
Subjects with T1DM for at least 10 years and CAC \< 100
Type 1 Diabetes High Risk Group
Subjects with T1DM for at least 10 years and CAC \> or = 100
Overall Study
Withdrawal by Subject
1
1
1

Baseline Characteristics

Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Non Diabetic Controls
n=4 Participants
Subjects with Coronary Artery Calcium (CAC score\> 100 in the CACTI Stdy)
Type 1 Diabetes Low Risk Group
n=4 Participants
Subjects with T1DM for at least 10 years and CAC \< 100
Type 1 Diabetes High Risk Group
n=15 Participants
Subjects with T1DM for at least 10 years and CAC \> or = 100
Total
n=23 Participants
Total of all reporting groups
Sex: Female, Male
Male
3 Participants
n=5 Participants
4 Participants
n=7 Participants
11 Participants
n=5 Participants
18 Participants
n=4 Participants
Region of Enrollment
United States
4 participants
n=5 Participants
4 participants
n=7 Participants
15 participants
n=5 Participants
23 participants
n=4 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
4 Participants
n=7 Participants
13 Participants
n=5 Participants
21 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=4 Participants
Age, Continuous
62.0 years
STANDARD_DEVIATION 1.6 • n=5 Participants
59.3 years
STANDARD_DEVIATION 10.1 • n=7 Participants
57.3 years
STANDARD_DEVIATION 5.2 • n=5 Participants
59.8 years
STANDARD_DEVIATION 8.2 • n=4 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 1 month

Population: 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.

Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.

Outcome measures

Outcome measures
Measure
Non Diabetic Controls
n=4 Participants
Subjects with Coronary Artery Calcium (CAC score\> 100 in the CACTI Stdy)
Type 1 Diabetes Low Risk Group
n=4 Participants
Subjects with T1DM for at least 10 years and CAC \< 100
Type 1 Diabetes High Risk Group
n=15 Participants
Subjects with T1DM for at least 10 years and CAC \> or = 100
Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects.
2.19 percentage of StressMBF/ Rest MBF
Standard Deviation 0.3
1.81 percentage of StressMBF/ Rest MBF
Standard Deviation 0.6
1.95 percentage of StressMBF/ Rest MBF
Standard Deviation 0.7

SECONDARY outcome

Timeframe: within 6 months

Population: 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..

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.

Outcome measures

Outcome measures
Measure
Non Diabetic Controls
n=3 Participants
Subjects with Coronary Artery Calcium (CAC score\> 100 in the CACTI Stdy)
Type 1 Diabetes Low Risk Group
Subjects with T1DM for at least 10 years and CAC \< 100
Type 1 Diabetes High Risk Group
Subjects with T1DM for at least 10 years and CAC \> or = 100
Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress.
1.5 CFR ratio
Standard Deviation 0.5
—
—

SECONDARY outcome

Timeframe: 1 month

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.

Outcome measures

Outcome measures
Measure
Non Diabetic Controls
n=4 Participants
Subjects with Coronary Artery Calcium (CAC score\> 100 in the CACTI Stdy)
Type 1 Diabetes Low Risk Group
n=4 Participants
Subjects with T1DM for at least 10 years and CAC \< 100
Type 1 Diabetes High Risk Group
n=15 Participants
Subjects with T1DM for at least 10 years and CAC \> or = 100
Myocardial Perfusion Index
1.09 percentage of Ratio Stress/ rest counts
Standard Deviation .19
1.4 percentage of Ratio Stress/ rest counts
Standard Deviation .60
1.12 percentage of Ratio Stress/ rest counts
Standard Deviation .32

Adverse Events

Non Diabetic Controls

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Type 1 Diabetes Low Risk Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Type 1 Diabetes High Risk Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert A. Quaife M.D.

University of Colorado, Denver

Phone: 720-848-6562

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place