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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 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.

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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.

Conditions Studied

Coronary Artery Disease Heart Diseases Coronary Artery Bypass Grafting

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

FieldValue
Enrollment Target 2,300 participants
Start Date 2023-04-17
Est. Completion 2030-03
Phase NA

Sponsor

Weill Medical College of Cornell University

701 total trials

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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, categorized as NA. The registered enrollment target is 2,300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,276-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (80% higher). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.