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Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
NCT04124120 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04124120
The ClinicalTrials.gov registry entry for NCT04124120 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 679 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04124120 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Nebraska, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04124120?
The interventions under investigation include: Single arterial graft (PROCEDURE), Multiple arterial grafting (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04124120?
This trial is sponsored by Weill Medical College of Cornell University, which has 679 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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