Phase 4
N=26
Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)
Coronary Artery Disease · Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01019486 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects. — 2.19; 1.81; 1.95 percentage of StressMBF/ Rest MBF — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Regadenoson myocardial perfusion imaging (Drug); Regadenoson MRI myocardial blood flow (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects. |
2.19; 1.81; 1.95 | <0.05 sig |
| SECONDARY Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress. |
1.5 | 0.05 |
| SECONDARY Myocardial Perfusion Index |
1.09; 1.4; 1.12 | <.05 sig |
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)
- Completed visit 6yr f/u CACTI Trial
- No history of previous MI, revascularization or angina
- CAC > 100
- Stratified random sample to reflect age-sex- distribution of the high risk diabetic group T1Diabetic subjects High-risk group (n= 10)
- Completed visit 6yr f/u CACTI Trial
- No history of previous MI, revascularization or angina
- CAC > 100
- preferably MPR of > 1.5 T1Diabetic subjects Lower-risk group (n= 10)
- Completed visit 1.A and 1.B CACTI Trial
- No history of previous MI, revascularization or angina
- CAC 50% reduction in lumen diameter of left main coronary artery
- Asthma requiring daily bronchodilators
- Methylxanthine therapy
- Moderate to severe renal insufficiency: GFR < 40 mL/min
Data sourced from ClinicalTrials.gov (NCT01019486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.