The ROMA Trial
Research type
Research Study
Full title
Randomised comparison of the clinical Outcome of single versus Multiple Arterial grafts
IRAS ID
321239
Contact name
Gavin Murphy
Contact email
Sponsor organisation
Weill Cornell Medicine/NewYork-Presbyterian Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
14 years, 5 months, 30 days
Research summary
A coronary artery bypass graft (CABG) is a surgical procedure used to treat coronary heart disease. It diverts blood around narrowed or clogged parts of the major arteries to improve blood flow and oxygen supply to the heart. Like all organs in the body, the heart needs a constant supply of blood which comes through arteries called coronaries. Over time, these arteries can become narrowed and hardened by the build-up of fatty deposits called atherosclerosis plaques.
CABG involves taking a blood vessel from another part of the body and attaching it to the coronary artery past the narrowed area. This new blood vessel is known as a graft. Currently an artery is used for the first graft and either an artery or vein is used for a second graft. It is unclear if either an artery or a vein is better for the second graft. Observational evidence suggests that the use of multiple arterial grafts leads to better outcomes. However, the only way to know for sure is to compare both methods in a well-designed research study.
The ROMA trial aims to answer this question by investigating the effect of single arterial grafts (SAG) vs multiple arterial grafts (MAG) for patients undergoing CABG. People who are suitable and consent to take part (and who require CABG for coronary heart disease) will be randomly assigned to receive SAG or MAG in a 1:1 fashion.
Surgery will take place within 4 weeks after randomisation. Participants will be followed up in clinics up to 12 weeks after surgery or as per their hospital’s routine. Subsequent follow-up will be performed at 6 months after surgery and every 6 months thereafter by telephone. It is expected that participants will be part of the trial for at least 5 years, with the possibility of up to 12 years.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0064
Date of REC Opinion
24 Mar 2023
REC opinion
Further Information Favourable Opinion