Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D) (RABIT1D)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Coronary Artery Disease Type 1 Diabetes Mellitus | Drug: Regadenoson myocardial perfusion imaging Drug: Regadenoson MRI myocardial blood flow | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
| Official Title: | Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D) |
- Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects. [ Time Frame: 1 month ]Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.
- Measured Coronary Blood Flow is Directly Correlated With Coronary Flow Reserve Measured Invasively in the Cardiac Catheterization Laboratory After Regadenoson Pharmacologic Stress. [ Time Frame: within 6 months ]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.
- Myocardial Perfusion Index [ Time Frame: 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.
| Enrollment: | 26 |
| Study Start Date: | November 2009 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Type 1 Diabetic Subjects
Regadenoson 400mcg slow IV bolus to identify assess myocardial blood flow (MBF). Stratified by coronary calcium score of below 100 or greater than score of 100 for low and high risk individuals respectively.
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Drug: Regadenoson myocardial perfusion imaging
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.
Other Names:
Drug: Regadenoson MRI myocardial blood flow
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.
Other Names:
|
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Active Comparator: Nondiabetic Subjects
Regadenoson myocardial perfusion imaging (MPI) Intervention: Regadenoson (400mcg slow IV bolus) stress to assess myocardial blood flow (MBF) and MPI to identify occult coronary artery disease (CAD). These individuals serve as an active control with higher risk non-diabetic individuals with scores greater than 100.
|
Drug: Regadenoson myocardial perfusion imaging
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.
Other Names:
Drug: Regadenoson MRI myocardial blood flow
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.
Other Names:
|
Show Detailed Description
Eligibility
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| Ages Eligible for Study: | 25 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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CAC < 100
Exclusion Criteria:
2. Exclusion Criteria:
- Pregnant or lactating women, women who plan to become pregnant
- Claustrophobia
- Moderate or severe congestive heart failure at baseline, Left ventricular ejection fraction (LVEF) < 25%
- Uncontrolled hypertension
- Unwillingness to complete all components of the study
- Significant CAD or prior revascularization
- Smoker
- Subject cannot have >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
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019486
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes | |
| Aurora, Colorado, United States, 80045 | |
| University of Colorado Denver | |
| Aurora, Colorado, United States, 80045 | |
| University of Colorado Hospital | |
| Aurora, Colorado, United States, 80045 | |
| University Hospital, the University of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| Principal Investigator: | Robert A. Quaife, M.D | University of Colorado, Denver |
More Information
Publications:
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01019486 History of Changes |
| Other Study ID Numbers: |
09-0426 |
| First Submitted: | November 23, 2009 |
| First Posted: | November 25, 2009 |
| Results First Submitted: | January 2, 2013 |
| Results First Posted: | December 14, 2015 |
| Last Update Posted: | December 14, 2015 |
| Last Verified: | November 2015 |
Keywords provided by University of Colorado, Denver:
|
Myocardial blood flow Cardiac magnetic resonance imaging Myocardial perfusion imaging Coronary artery flow reserve Regadenoson |
Additional relevant MeSH terms:
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Diabetes Mellitus Coronary Artery Disease Myocardial Ischemia Coronary Disease Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Autoimmune Diseases Immune System Diseases Regadenoson Adenosine A2 Receptor Agonists Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |