Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Cardiovascular disease (CVD) remains the major cause of mortality and morbidity in both type 1 (T1D) and type 2 (T2D) diabetes patients; modifications of traditional CVD risk factors have had a limited impact. This project called Regadenoson Blood flow in Type 1 Diabetes (RABIT1D) and is proposed as a sub-study of the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study, which has established a unique cohort of 656 T1D patients (age 20-55, minimal diabetes duration of 10 yrs) and 764 non-diabetic controls. This cohort is being followed for progression of coronary artery calcification (CAC) measured using the electron beam tomography (EBT) for development of clinical CVD. Participants have been well characterized during the baseline examination (4/00-3/02) and two follow-up re-examinations 3 and 6 years later. The study has provided important insights into the risk factors and possible prevention of premature CVD in T1D. We are proposing assess a subset of this population to determine vasodilatory reserve as it relates to early coronary atherosclerosis in T1D.

Hypothesis: that myocardial blood imaging (MBF) reserve can be measured in Type 1 diabetes mellitus (DM) using regadenoson stress cardiac magnetic resonance and that significantly reduced MBF is a marker of extensive atherosclerotic disease correlated to coronary arterial calcification, plaque formation and impaired vasodilatory reserve.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Regadenoson; Technetium Tc 99m Sestamibi

Criteria

Inclusion Criteria:

• 1. Inclusion Criteria Nondiabetic controls High-risk (n=5)

1. Completed visit 6yr f/u CACTI Trial

2. No history of previous MI, revascularization or angina

3. CAC > 100

4. Stratified random sample to reflect age-sex- distribution of the high risk diabetic group T1Diabetic subjects High-risk group (n= 10)

1. Completed visit 6yr f/u CACTI Trial

2. No history of previous MI, revascularization or angina

3. CAC > 100

4. preferably MPR of > 1.5 T1Diabetic subjects Lower-risk group (n= 10)

1. Completed visit 1.A and 1.B CACTI Trial

2. No history of previous MI, revascularization or angina

3. CAC < 100

Exclusion Criteria:

2. Exclusion Criteria:

1. Pregnant or lactating women, women who plan to become pregnant

2. Claustrophobia

3. Moderate or severe congestive heart failure at baseline, Left ventricular ejection fraction (LVEF) < 25%

4. Uncontrolled hypertension

5. Unwillingness to complete all components of the study

6. Significant CAD or prior revascularization

7. Smoker

8. Subject cannot have >50% reduction in lumen diameter of left main coronary artery

9. Asthma requiring daily bronchodilators

10. Methylxanthine therapy

11. Moderate to severe renal insufficiency: GFR < 40 mL/min