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Procedure

Single vs Multiple Arterial Grafts for Heart Disease (ROMA:Women Trial)

N/A

Recruiting

Led By Roberto Lorusso, Prof/PhD/MD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Isolated coronary artery bypass grafting

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

Must not have

Previous cardiac surgery

Male gender

Timeline

Screening 3 weeks

Treatment Varies

Follow Up > 48 hours postoperatively, minimum 2.5 year follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the outcomes of women who receive one arterial graft during CABG surgery (SAG) to those who receive multiple arterial grafts (MAG).

Who is the study for?

This trial is for women over 18 facing their first heart surgery due to significant coronary artery disease. They must not have had previous cardiac surgeries, recent heart attacks, severe heart failure, or other serious health issues that could limit life expectancy.

What is being tested?

The study compares the effectiveness of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing bypass surgery. It aims to see if MAG can better prevent major heart and brain events and improve quality of life.

What are the potential side effects?

While specific side effects are not listed, typical risks may include complications from surgery such as infection, bleeding, stroke, or adverse reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery to improve blood flow to my heart.

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I have severe heart artery disease affecting the main or left arteries.

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I am a woman aged 18 or older.

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I am having my first heart surgery.

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I am having my first heart surgery.

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I have had surgery to improve blood flow to my heart.

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I have severe heart artery disease affecting the main or major side arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had heart surgery in the past.

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I am male.

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I do not have severe organ problems or other health issues that could shorten my life to under 5 years.

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I am scheduled for a combined surgical and non-surgical procedure to improve blood flow.

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I cannot use my saphenous vein or both my radial and right internal thoracic arteries.

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I need an emergency surgery.

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I had a heart attack less than 3 days before my surgery.

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I am undergoing or have undergone other heart or non-heart related surgeries.

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I am expected to need surgery to remove blockages from my heart's arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ > 48 hours postoperatively, minimum 2.5 year follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~> 48 hours postoperatively, minimum 2.5 year follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and > 48 hours postoperatively, minimum 2.5 year follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cerebral Revascularization

Disease

Secondary study objectives

Death from any cause

Cerebral Revascularization

+8 more

Other study objectives

Other recorded outcomes (safety endpoints)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Single Arterial Graft (SAG) groupExperimental Treatment1 Intervention

Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.

Group II: Multiple Arterial Graft (MAG) groupExperimental Treatment1 Intervention

Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.

0 / 16Eligibility criteria met