drugset / Trial / NCT01019486

Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)

NCT01019486

Phase 4 Completed 26 enrolled University of Colorado, Denver
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2009-11
Primary completion
2011-12
Completion
2011-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Regadenoson Diagnostic / imaging agent 400 ug Intravenous
Background Gadoteridol Diagnostic / imaging agent 0.04 mmol Intravenous
Background Gadoteridol Diagnostic / imaging agent 0.05 mmol Intravenous
Background Tc99m sestamibi Diagnostic / imaging agent 30 unknown