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The study is to determine the effect and outcomes of single vs multiple arterial revascularization for patients undergoing coronary artery bypass surgery

Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial - ROMA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034072
Enrollment
4300
Registered
2021-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Multiple Arterial Group: 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

Sponsors

Weill Medical College of Cornell University
Lead Sponsor
Canadian Institutes of Health Research CIHR
Collaborator
National Heart Lung and Blood Institute NHLBI
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Male or female aged between 18 Years to 70 Years(Adult, Older Adult) Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery Able to provide written informed consent

Exclusion criteria

Exclusion criteria: Age > 70 years Single graft Emergency operation Evolving myocardial infarction within 48 hours of surgery Left ventricular ejection fraction of less than 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 reduce 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 Not able to provide written informed consent

Design outcomes

Primary

MeasureTime frame
Composite Outcome A composite of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization Timepoint: Time Frame: morethan 72 hours after surgery and/or repeat revascularization—

Secondary

MeasureTime frame
1. 30-day mortality -Death from any cause at 30-days 2. Major postoperative complications 3. Sternal wound complication 4. Composite Outcome of Death from any cause 5. Stroke 6. Cause-specific death (cardiac vs non-cardiac) 7. Hospital readmissions Timepoint: 30days to 5 years—

Countries

Austria, Canada, China, Croatia, Germany, India, Italy, Japan, Netherlands, Portugal, Republic of Korea, Serbia, Singapore, United States of America

Contacts

Public ContactDr Lokeswara Rao Sajja

Star Hospitals

sajjalr@yahoo.com9849028317

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026