Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: In-hospital stay, up to 30 days post-operatively

4300 Participants Needed

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

Recruiting at 58 trial locations

Overseen ByMarshagay Rodriques

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Age > 70, Previous cardiac surgery, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Multiple Arterial Grafting for heart disease?

Research shows that using multiple arterial grafts in heart surgery can lead to better survival rates and fewer heart problems compared to using just one arterial graft. This approach is especially beneficial for patients undergoing coronary artery bypass surgery.¹ ² ³ ⁴ ⁵

Is it safe to use multiple arterial grafts for heart surgery?

Multiple arterial grafts in heart surgery, like coronary artery bypass grafting (CABG), are generally safe and can improve long-term outcomes without increasing early death or complications. Studies show that using more than one artery for grafting can lead to better survival rates.¹ ² ³ ⁶ ⁷

How does the treatment of multiple arterial grafting differ from single arterial grafting for heart disease?

Multiple arterial grafting involves using more than one artery to improve blood flow to the heart, which can lead to better long-term survival and fewer repeat surgeries compared to using just one artery. This approach is particularly beneficial for patients undergoing coronary artery bypass surgery, as it provides a more durable solution for heart disease.¹ ² ³ ⁶ ⁷

What is the purpose of this trial?

The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.Prospective event-driven unblinded randomized multicenter trial of at least 4,300 subjects enrolled in at least 25 international centers. Patients will be randomized to a single arterial graft (SAG) or multiple arterial grafts (MAG). Patients will be randomized in a 1:1 fashion between the two groups. Permuted block randomization with random blocks stratified by the center and the type of second arterial graft will be used to provide treatment distribution in equal proportion.

Research Team

Fremes, Stephen - Institute of Health ...

Stephen Fremes, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Mario Gaudino, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for patients with coronary artery disease who need non-emergency heart bypass surgery and haven't had previous cardiac surgeries. It's not for those over 70, with recent heart attacks, severe heart failure, or other serious health issues that could limit life expectancy to under 5 years.

Inclusion Criteria

I have heart disease affecting specific arteries.

Exclusion Criteria

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

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

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

See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo coronary artery bypass surgery with either single or multiple arterial grafts

In-hospital stay, up to 30 days post-operatively

Hospital stay

Follow-up

Participants are monitored for major postoperative complications and composite outcomes

5 years

Regular follow-up visits

Long-term follow-up

Analysis of composite outcomes and cause-specific death

5 years

Treatment Details

Interventions

Multiple Arterial Grafting
Single Arterial Graft

Trial Overview The ROMA trial is testing if using multiple arterial grafts in heart bypass surgery is better than a single graft at reducing death, strokes, heart attacks, and the need for more surgery. Patients are randomly assigned to either group in equal numbers across international centers.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Single Arterial 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 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 Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

In a study of 336,321 patients undergoing isolated coronary artery bypass grafting (CABG) in the UK from 1996 to 2018, the use of multiple arterial grafting (MAG) initially increased but then steadily declined, particularly the use of the radial artery.

Patients receiving single arterial grafting had lower in-hospital mortality rates and fewer complications, such as the need for return to surgery for bleeding, suggesting that while MAG has benefits, single arterial grafting may be safer in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trend and factors associated with multiple arterial revascularization in coronary artery bypass grafting in the UK.Chan, J., Dimagli, A., Dong, T., et al.[2022]

In a study of 63,402 patients undergoing coronary artery bypass graft surgery, those receiving multiple arterial grafts (MAGs) showed lower mortality rates at 7 years compared to those receiving single arterial grafts (SAGs), with a significant adjusted hazard ratio of 0.86.

While there was no difference in mortality between MAG and SAG patients at 1 year, MAG patients had better long-term outcomes, including lower rates of repeat revascularization and a composite outcome of mortality, myocardial infarction, and stroke after 7 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple Versus Single Arterial Coronary Bypass Graft Surgery for Multivessel Disease.Samadashvili, Z., Sundt, TM., Wechsler, A., et al.[2020]