Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial

Plain English Summary

Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women is a Not Applicable clinical trial sponsored by Weill Medical College of Cornell University studying Heart Diseases, Coronary Artery Disease, Coronary Artery Bypass Grafting. This trial compares two methods of heart bypass surgery for women: using a single arterial graft versus multiple arterial grafts. It is for women aged 18 and older who need their first coronary artery bypass grafting surgery due to significant blockages in their heart arteries. Participation involves being randomly assigned to receive either single or multiple arterial grafts, followed by regular check-ups for at least 2.5 years. Alternatives include standard bypass surgery using only vein grafts, or less invasive procedures if suitable. The trial aims to enroll 2300 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18 or older. Must be undergoing their first-time bypass surgery for significant blockages in major heart arteries. Cannot have had a heart attack within 72 hours of surgery, have severe heart pumping problems (ejection fraction <35%), or other serious health issues that limit life expectancy. Cannot be having other heart or non-heart surgeries at the same time, or have had previous heart surgery. This trial is studying Heart Diseases, Coronary Artery Disease, Coronary Artery Bypass Grafting, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures assess major adverse events like death, stroke, heart attack, and the need for repeat procedures, as well as quality of life, to see if using multiple arterial grafts prov The specific primary outcome measures are: Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure. (Postoperatively, minimum 2.5 year follow-up); Primary outcome for aim 2: Disease-specific quality of life (Postoperatively, minimum 2.5 year follow-up). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to determine if using multiple arterial grafts in women undergoing bypass surgery leads to better long-term heart health and quality of life compared to the standard single arterial gr This research targets Heart Diseases, Coronary Artery Disease, Coronary Artery Bypass Grafting, where improved treatment options are needed.

Investor Insight

This trial investigates a potentially superior surgical technique for a common cardiac procedure, with implications for patient outcomes and healthcare costs, suggesting a focus on optimizing surgical The large enrollment target of 2300 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if you are a candidate for this trial and what the specific risks and benefits of each grafting method are for you. Understand that you will be randomly assigned to one of the two surgical groups, and you will need to attend follow-up appointments for several years. Be prepared for potential recovery time and lifestyle adjustments after surgery, and discuss any concerns about your quality of life with your medical team. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 2,300 participants

Interventions

• PROCEDURE: Single arterial graft — This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
• PROCEDURE: Multiple arterial grafting — This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.

Primary Outcomes

• Primary outcome for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure. (Postoperatively, minimum 2.5 year follow-up)
• Primary outcome for aim 2: Disease-specific quality of life (Postoperatively, minimum 2.5 year follow-up)

Secondary Outcomes

• Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization. (Postoperatively, minimum 2.5 year follow-up)
• Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure. (Postoperatively, minimum 2.5 year follow-up)
• Death from any cause (Postoperatively, minimum 2.5 year follow-up)
• Stroke (Postoperatively, minimum 2.5 year follow-up)
• Non-procedural myocardial infarction (> 48 hours postoperatively, minimum 2.5 year follow-up)

Full Eligibility Criteria

Inclusion Criteria:

1. Women patients ≥18 years old.
2. Isolated coronary artery bypass grafting.
3. Primary (first time) cardiac surgery procedure.
4. Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

Exclusion Criteria:

* Male gender
* Single graft
* Emergency operation
* Myocardial infarction within 72 hours of surgery
* Left ventricular ejection fraction \< 35%
* Any concomitant cardiac or non-cardiac procedure
* Previous cardiac surgery
* Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.
* Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
* Anticipated need for coronary thrombo-endarterectomy
* Planned hybrid revascularization

Trial Locations

• Cedars-Sinai Medical Center, Los Angeles, California, United States
• Pomona Valley Hospital Medical Center, Pomona, California, United States
• University of California, San Francisco, San Francisco, California, United States
• University of Colorado, Aurora, Colorado, United States
• Hartford Hospital, Hartford, Connecticut, United States
• Yale University Hospital, New Haven, Connecticut, United States
• Emory University, Atlanta, Georgia, United States
• University of Chicago, Chicago, Illinois, United States
• Indiana University, Indianapolis, Indiana, United States
• University of Iowa, Iowa City, Iowa, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Heart Diseases
• Coronary Artery Disease
• Coronary Artery Bypass Grafting
• Cardiovascular Diseases
• Ischemic Heart Disease
• Atherosclerosis
• Heart Failure
• Myocardial Infarction
• Angina Pectoris
• Vascular Diseases

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