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NCT03217006 · ClinicalTrials.gov registry record · NA
Randomization of Single vs Multiple Arterial Grafts
A NA study of Coronary Artery Disease and Heart Diseases, sponsored by Weill Medical College of Cornell University.
- Active
- Registry status
- NA
- Development phase
- 4,300
- Enrollment target
- 20
- Study locations
NCT03217006: Active NA study of Coronary Artery Disease and Heart Diseases, sponsored by Weill Medical College of Cornell University.
NCT03217006 is a NA study of Coronary Artery Disease and Heart Diseases that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 4,300 participants, above the 1,267-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (239% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03217006, a NA study of Coronary Artery Disease and Heart Diseases, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 4,300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival. Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.
Primary Outcome
A composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.
Conditions Studied
Interventions
- PROCEDURE Single arterial graft
- PROCEDURE Multiple arterial grafting
Study Locations (20)
Other
- Innsbruck (Medical University) Austria - Innsbruck
- Krankenhaus Nord Vienna North Hospital - Vienna
- MU Vienna Austria - Vienna
- Federal University of Sao Paulo - São Paulo
- Hamilton General Hospital - Hamilton
- London Health Sciences Ontario Canada - London
- University Hospital of Montreal (CHUM) - Montreal
- University of Ottawa Heart Institute Canada - Ottawa
- Royal Victoria Hospital (McGill) - Québec
New York
- NewYork-Presbyterian Brooklyn Methodist Hospital - Brooklyn
- Icahn School of Medicine, Mount Sinai - New York
- Weil Cornell Medical College Department of Cardiothoracic Surgery - New York
- Lenox Hill Hospital (Northwell) - New York
- NewYork-Presbyterian Queens - New York
Nebraska
- Nebraska Heart Hospital - Lincoln
- University of Nebraska Medical Center - Omaha
Colorado
- University of Colorado - Boulder
Massachusetts
- Baystate Health - Springfield
Ohio
- Cleveland Clinic Foundation - Cleveland
Pennsylvania
- Allegheny General Hospital (Cardiovascular Institute) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,300 participants |
| Start Date | 2018-01-07 |
| Est. Completion | 2030-01-01 |
| Phase | NA |
What the registry record for NCT03217006 still lists
NCT03217006 is an interventional study that assigns participants to a tested intervention. Its 4,300 participants enrollment target places it among the larger protocols in the corpus, above the 1,267-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (239% higher).
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Single arterial graft is the first listed.
NCT03217006 names 20 study sites across 7 states, led by Other, New York, Nebraska.
Frequently Asked Questions
What is clinical trial NCT03217006 about?
NCT03217006 is a clinical study titled "Randomization of Single vs Multiple Arterial Grafts". The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, p...
What is the current status of trial NCT03217006?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 4,300 participants. The study started on 2018-01-07. Estimated completion is 2030-01-01.
What conditions does trial NCT03217006 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Heart Diseases.
What interventions are being tested in trial NCT03217006?
The interventions under investigation include: Single arterial graft (PROCEDURE), Multiple arterial grafting (PROCEDURE).
Who is sponsoring clinical trial NCT03217006?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03217006 being conducted?
This trial has 20 study locations across Colorado, Massachusetts, Nebraska, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03217006's enrollment target sits among peer trials
4,300 15th of 219 higher than 205 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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