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Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D) (RABIT1D)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01019486
First received: November 23, 2009
Last updated: November 9, 2015
Last verified: November 2015
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)

Resource links provided by NLM:

Drug Information available for: Regadenoson
U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Coronary Blood Flow Assessment With Regadenoson Stress by Cardiac MRI Between Non-diabetic and Type 1 Diabetic Subjects. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
 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:
  • Cardiolite (sestamibi)
  • Regadenoson (Lexiscan)
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:
  • Regadenoson (Lexiscan)
  • Prohance (Gadoteridol)
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:
  • Cardiolite (sestamibi)
  • Regadenoson (Lexiscan)
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:
  • Regadenoson (Lexiscan)
  • Prohance (Gadoteridol)

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019486

Locations
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
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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 
Study First Received: November 23, 2009
Results First Received: January 2, 2013
Last Updated: November 9, 2015
Health Authority: United States: Food and Drug Administration

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:
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

ClinicalTrials.gov processed this record on September 29, 2016