ROMA trial
Research type
Research Study
Full title
Randomized comparison of the clinical Outcome of single versus Multiple Arterial grafts: the ROMA trial.
IRAS ID
232868
Contact name
Cristiano Spadaccio
Contact email
Sponsor organisation
Weill Cornell Medicine
Clinicaltrials.gov Identifier
Duration of Study in the UK
13 years, 0 months, 1 days
Research summary
Coronary artery bypass graft (CABG) is a surgical procedure used to treat coronary heart disease. It entails the diversion of blood around narrowed or clogged parts of the major arteries of the heart (coronaries) to improve blood flow and oxygen supply. This procedure is required when more than two coronaries are obstructed. Around 20,000 CABGs are carried out in England every year. Currently, an artery, namely the left internal thoracic artery(LITA) is used as conduit to bypass(graft) the most important coronary artery of the heart, the left anterior descending artery(LAD), which supplies blood to the majority of the heart muscle. It has been established that using the LITA improves outcomes in patients undergoing CABG surgery. For the second grafts, either an artery (the right internal thoracic artery or the radial artery from the arm) or vein conduits from the leg can be used. However, is unclear if either an artery or a vein is better for the second graft(s). The purpose of the study is to determine if one is better than the other. The results will help answer this question and establish the best future surgical practice for millions of patients around the world that are affected by coronary artery disease. A multicentric study involving 68 cardiac surgery units around the world has been therefore designed to enrol 4300 patients needing CABG.\nRecruited patient will receive an artery to graft their main coronary and be randomly assigned to a group in which they will receive multiple arterial grafts (MAG, i.e. an artery for the LAD+other arterial conduit for the secondary grafts) or single arterial graft (SAG, i.e. only one artery for LAD and veins for the rest). No deviation from the standard care is planned, but the patients will be followed up with phone interview on their status for up to 10 years. \n
REC name
North of Scotland Research Ethics Committee 2
REC reference
18/NS/0003
Date of REC Opinion
22 Jan 2018
REC opinion
Further Information Favourable Opinion