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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: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT01019486 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measurement of Myocardial blood flow measurements (MBF) and myocardial perfusion index obtained from 6 regions within the mid ventricular LV short axis slice.
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 |
What the finished NCT01019486 record still lists
NCT01019486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Regadenoson myocardial perfusion imaging is the first listed.
NCT01019486 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01019486's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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