Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)
Condition: Coronary Artery Disease; Type 1 Diabetes Mellitus
MeSH terms: Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Regadenoson myocardial perfusion imaging; Regadenoson MRI myocardial blood flow
Intervention description: Myocardial perfusion imaging at rest and following 400mcg Regadenoson IV bolus pharmacologic stress with 30 mCi of Tc-99m sestamibi injected at both but the studies performed 48 hours apart.; CMR assessment of stress myocardial perfusion and blood flow after 400 mcg Regadenoson pharmacologic using gadolinium contrast (gadoteridol) 0.05mmole/kg at stress and rest.
Intervention MeSH terms: Regadenoson; Technetium Tc 99m Sestamibi
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Myocardial blood flow; Cardiac magnetic resonance imaging; Myocardial perfusion imaging; Coronary artery flow reserve; Regadenoson

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.
    

Eligibility 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