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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 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
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.

Find a Location

Who is running the clinical trial?

Duke UniversityOTHER
2,462 Previous Clinical Trials
2,966,920 Total Patients Enrolled
17 Trials studying Coronary Artery Disease
48,795 Patients Enrolled for Coronary Artery Disease
Oxford University Hospitals NHS TrustOTHER
220 Previous Clinical Trials
1,699,310 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
23,976 Patients Enrolled for Coronary Artery Disease
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,152,746 Total Patients Enrolled
15 Trials studying Coronary Artery Disease
46,443 Patients Enrolled for Coronary Artery Disease
New York Presbyterian HospitalOTHER
75 Previous Clinical Trials
55,266 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
681 Previous Clinical Trials
1,563,758 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
2,197 Patients Enrolled for Coronary Artery Disease
Cedars-Sinai Medical CenterOTHER
513 Previous Clinical Trials
161,389 Total Patients Enrolled
22 Trials studying Coronary Artery Disease
15,387 Patients Enrolled for Coronary Artery Disease
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,765,125 Total Patients Enrolled
12 Trials studying Coronary Artery Disease
12,496 Patients Enrolled for Coronary Artery Disease
University of GöttingenOTHER
68 Previous Clinical Trials
42,012 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
1,121 Patients Enrolled for Coronary Artery Disease
Maastricht University Medical CenterLead Sponsor
978 Previous Clinical Trials
3,299,500 Total Patients Enrolled
13 Trials studying Coronary Artery Disease
52,642 Patients Enrolled for Coronary Artery Disease
Roberto Lorusso, Prof/PhD/MDPrincipal InvestigatorMaastricht University Medical Centre, Maastricht, The Netherlands

Media Library

Multiple arterial grafting (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04124120 — N/A
Coronary Artery Disease Research Study Groups: Single Arterial Graft (SAG) group, Multiple Arterial Graft (MAG) group
Coronary Artery Disease Clinical Trial 2023: Multiple arterial grafting Highlights & Side Effects. Trial Name: NCT04124120 — N/A
Multiple arterial grafting (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04124120 — N/A
~1333 spots leftby Mar 2030
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