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NCT01161121 · ClinicalTrials.gov registry record · Phase 1
Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia
A Phase 1 study of Coronary Artery Disease, sponsored by St. Louis University.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
- 2
- Study locations
NCT01161121: Completed Phase 1 study of Coronary Artery Disease, sponsored by St. Louis University.
NCT01161121 is a Phase 1 study of Coronary Artery Disease that has completed, run by St. Louis University. The registered enrollment target is 46 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01161121, a Phase 1 study of Coronary Artery Disease, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine if regadenoson is as safe and effective as adenosine when used in the cardiac catheterization lab during measurement of coronary flow reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising patient safety.
Primary Outcome
FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson
Conditions Studied
Interventions
- DRUG adenosine
- DRUG regadenoson
Study Locations (2)
Florida
- University of Florida - Jacksonville
Missouri
- St. Louis University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01161121 record still lists
NCT01161121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which adenosine is the first listed.
NCT01161121 reports a single indexed study location in Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT01161121 about?
NCT01161121 is a clinical study titled "Comparison of Intravenous Adenosine Infusion With Regadenoson Bolus for Inducing Maximal Coronary Hyperemia". The purpose of this study is to determine if regadenoson is as safe and effective as adenosine when used in the cardiac catheterization lab during measurement of coronary flow reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional Flow Reserve (FFR) in the catheter...
What is the current status of trial NCT01161121?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2010-07. Estimated completion is 2013-04.
What conditions does trial NCT01161121 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT01161121?
The interventions under investigation include: adenosine (DRUG), regadenoson (DRUG).
Who is sponsoring clinical trial NCT01161121?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01161121 being conducted?
This trial has 2 study locations across Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01161121's enrollment target sits among peer trials
46 185th of 219 higher than 35 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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.
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