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NCT01019486 · ClinicalTrials.gov registry record · Phase 4
Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01019486 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 26 participants.
The verdict
NCT01019486, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study 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.
Interventions
- DRUG Regadenoson myocardial perfusion imaging
- DRUG Regadenoson MRI myocardial blood flow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01019486
The ClinicalTrials.gov registry entry for NCT01019486 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Regadenoson myocardial perfusion imaging is the first listed.
NCT01019486 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01019486 about?
NCT01019486 is a clinical study titled "Regadenoson Blood Flow in Type 1 Diabetes (RABIT1D)". 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...
What is the current status of trial NCT01019486?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2009-11. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01019486?
The interventions under investigation include: Regadenoson myocardial perfusion imaging (DRUG), Regadenoson MRI myocardial blood flow (DRUG).
Who is sponsoring clinical trial NCT01019486?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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