Comparing Single arterial graft with Multiple arterial grafting for heart diseases
Official title: Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
- 2 groups
- Sites in Montreal, New Westminster and 9 more cities
- Recruiting
Interventions
- Medical procedure
Single arterial graft
This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
- Medical procedure
Multiple arterial grafting
This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
Canadian Sites (16)
15 of 16 recruiting
- Recruiting
Mazankowski Alberta Heart Institute
Edmonton, Alberta
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba
- Recruiting
Hopital Sacre-Coeur
Montreal
- Recruiting
Horizon Health Network - Saint John Regional Hospital
Saint John, New Brunswick
- Recruiting
Fraser Clinical Trials
New Westminster
- Recruiting
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador
- Recruiting
Health Sciences North
Greater Sudbury, Ontario
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
London Health Sciences
London, Ontario
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Recruiting
Sunnybrook Health Sciences
Toronto, Ontario
- Recruiting
Montreal Heart Institute
Montreal, Quebec
- Recruiting
University Hospital of Montreal
Montreal, Quebec
- Recruiting
Royal Victoria Hospital
Montreal, Quebec
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Ste Foy, Quebec
- Not yet recruiting
Toronto General Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Women patients ≥18 years old.
- +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.
- +Primary (first time) cardiac surgery procedure.
Exclusion
- −Male gender
- −Single graft
- −Emergency operation
- −Left ventricular ejection fraction \< 35%
- −Any concomitant cardiac or non-cardiac procedure
- −Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces 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
- −Myocardial infarction within 72 hours of surgery
- −Previous cardiac surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Single arterial graft.
Registry label: A: Single Arterial Graft (SAG) group
Group B receives Multiple arterial grafting.
Registry label: B: Multiple Arterial Graft (MAG) group
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,300 people.
The study is currently expected to finish around March 2030.
The main measurement is taken over: Postoperatively, minimum 2.5 year follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Primary outcomePrimary endpointThe single main question the study is designed to answer.Read more → for aim 1: Death from any cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure — measured over Postoperatively, minimum 2.5 year follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
Primary outcome for aim 2: Disease-specific quality of life — measured over Postoperatively, minimum 2.5 year follow-up.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04124120 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Single arterial graftProcedure
This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Multiple arterial graftingProcedure
This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Postoperatively, minimum 2.5 year follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
The study as a whole is currently expected to finish around 2030-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,300 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Montreal, Canada; New Westminster, Canada; Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Saint John, New Brunswick, Canada; St. John's, Newfoundland and Labrador, Canada, and 12 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.
Other Sites (7)
University of Michigan
Ann Arbor, Michigan, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Weill Cornell Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
New York Presbyterian Queens
Queens, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.