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NCT04124120 · ClinicalTrials.gov registry record · NA
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
A NA study of Coronary Artery Disease and Heart Diseases, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- NA
- Development phase
- 2,300
- Enrollment target
- 20
- Study locations
NCT04124120: Recruiting NA study of Coronary Artery Disease and Heart Diseases, sponsored by Weill Medical College of Cornell University.
NCT04124120 is a NA study of Coronary Artery Disease and Heart Diseases that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 2,300 participants, above the 1,276-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (80% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04124120, a NA study of Coronary Artery Disease and Heart Diseases, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- NA
- Development phase
- 2,300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
Primary Outcome
The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure.
Conditions Studied
Interventions
- PROCEDURE Single arterial graft
- PROCEDURE Multiple arterial grafting
Study Locations (20)
California
- Cedars-Sinai Medical Center - Los Angeles
- Pomona Valley Hospital Medical Center - Pomona
- University of California, San Francisco - San Francisco
Nebraska
- Nebraska Heart Hospital - Lincoln
- Methodist Physicians Health - Omaha
- University of Nebraska Medical Center - Omaha
Connecticut
- Hartford Hospital - Hartford
- Yale University Hospital - New Haven
Massachusetts
- Baystate Health - Springfield
- University of Massachusetts Chan Medical School - Worcester
Michigan
- University of Michigan - Ann Arbor
- Corewell Health William Beaumont University Hospital - Royal Oak
New Jersey
- Englewood Health - Englewood
- Newark Beth Israel Medical Center - Newark
Colorado
- University of Colorado - Aurora
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,300 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2030-03 |
| Phase | NA |
What NCT04124120 shows while recruiting
NCT04124120 is an interventional study that assigns participants to a tested intervention. Its 2,300 participants enrollment target places it among the larger protocols in the corpus, above the 1,276-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (80% higher).
The record links to 3 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Single arterial graft is the first listed.
NCT04124120 names 20 study sites across 12 states, led by California, Nebraska, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04124120 about?
NCT04124120 is a clinical study titled "Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women". The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and ...
What is the current status of trial NCT04124120?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,300 participants. The study started on 2023-04-17. Estimated completion is 2030-03.
What conditions does trial NCT04124120 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Heart Diseases, Coronary Artery Bypass Grafting.
What interventions are being tested in trial NCT04124120?
The interventions under investigation include: Single arterial graft (PROCEDURE), Multiple arterial grafting (PROCEDURE).
Who is sponsoring clinical trial NCT04124120?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04124120 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04124120's enrollment target sits among peer trials
2,300 27th of 219 higher than 193 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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