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Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
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 grfating (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 grfating (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 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women).
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.
Study details:
ROMA:Women will leverage the infrastructure and the existing women population of the ROMA trial. ROMA:Women has two key Aims. In Aim 1, 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 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women).
In Aim 2, 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. Differences by important 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. ROMA:Women is a two-arm, international, multi-center, randomized clinical trial nested in the ROMA trial.
ROMA:Women will include all the women enrolled in the parent ROMA trial and will leverage the existing ROMA infrastructure including clinical trial unit, database, case report forms (CRF), randomization system, site training resources, informed consent forms (ICF), regulatory approvals, Central Events Review Committee (CEC) processes/personnel, network of participating sites, site PIs, and study coordinators. The planned randomization procedure, interventions and treatment arms, outcome assessments and follow-up protocol of ROMA:Women are identical to those of the currently ongoing parent ROMA trial. The sites participating in ROMA will continue enrollment of women after the completion of the ROMA trial and additional sites will also be opened to reach the target sample size of ROMA:Women.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Female
Things to know
Study dates
Study start: 2023-04-17
Primary completion: 2030-03-01
Study completion finish: 2030-03-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT04124120
Intervention or treatment
PROCEDURE: Single arterial graft
PROCEDURE: Multiple arterial grafting
Conditions
- • Heart Diseases
- • Coronary Artery Disease
- • Coronary Artery Bypass Grafting
Find a site
Closest Location:
The University of Melbourne
Research sites nearby
Select from list below to view details:
The University of Melbourne
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Single Arterial Graft (SAG) group
| PROCEDURE: Single arterial graft
|
EXPERIMENTAL: Multiple Arterial Graft (MAG) group
| PROCEDURE: Multiple arterial grafting
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Primary outcome 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. | The primary outcome for aim 1 will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure. | Postoperatively, minimum 2.5 year follow-up |
| Primary outcome for aim 2: Disease-specific quality of life | Assessed using the Seattle Angina Questionnaire (SAQ), a validated 19-item questionnaire that measures five domains related to coronary disease: angina frequency, physical limitations, quality of life, angina stability, and treatment satisfaction. Scores range from 0 to 100 with higher scores indicating fewer symptoms and better health status. The minimum clinically important difference on the SAQ is 5 points. The primary endpoint for aim 2 is the absolute change in the Seattle Angina Questionnaire (SAQ) at 12 months compared to baseline. | Postoperatively, minimum 2.5 year follow-up |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization. | One of the secondary outcomes for aim 1: It will be a composite of the first occurrence of death from any cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), and repeat revascularization. This is the primary outcome of the parent ROMA trial. | Postoperatively, minimum 2.5 year follow-up |
| Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure. | Another secondary outcome for aim 1: It will be a composite of the first occurrence of death from cardiac cause, any stroke, non-procedural myocardial infarction (\>48 hours after surgery), repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure. | Postoperatively, minimum 2.5 year follow-up |
| Death from any cause | Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified. | Postoperatively, minimum 2.5 year follow-up |
| Stroke | Another secondary outcome for aim 1: Based on the American Heart Association/American Stroke Association Expert Consensus stroke definition, stroke will be identified in case of: 1. pathological, imaging, or other objective evidence of cerebral ischemic injury in a defined vascular distribution; OR 2. clinical evidence of cerebral ischemic injury based on symptoms persisting ≥24 hours or until death, and other etiologies excluded. | Postoperatively, minimum 2.5 year follow-up |
| Non-procedural myocardial infarction | Another secondary outcome for aim 1: Based on the 4th Universal Definition, non-periprocedural myocardial infarction will be identified in case of detection of rise and/or fall of cardiac biomarkers with at least one value above the 99th percentile of the upper reference limit together with evidence of myocardial ischemia with at least one of the following: 1. symptoms of ischemia 2. electrocardiogram changes indicative of new ischemia (new ST-T changes or new left bundle branch block) 3. development of pathological Q waves in the electrocardiogram 4. imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. | > 48 hours postoperatively, minimum 2.5 year follow-up |
| Repeat revascularization | Another secondary outcome for aim 1: Repeat revascularization will include any percutaneous or surgical revascularization on a grafted coronary artery after the initial operation. | Postoperatively, minimum 2.5 year follow-up |
| Readmission for acute coronary syndrome | Another secondary outcome for aim 1: Prolonged ischemic symptoms at rest (usually ≥10 minutes in duration), or accelerating pattern of chest pain that occurs with a lower activity threshold (CCS class III or IV) considered to be myocardial ischemia upon final diagnosis resulting in an unscheduled visit to a healthcare facility resulting in an overnight stay generally within 24 hours of the most recent symptoms, cardiac biomarkers not meeting MI criteria, and ECG or angiographic evidence of ischemia. | Postoperatively, minimum 2.5 year follow-up |
| Readmission for heart failure | Another secondary outcome for aim 1: While patients may have multiple simultaneous disease processes, for the outcome event of heart failure requiring hospitalization, the diagnosis of congestive heart failure would need to be the primary process. Heart failure (HF) requiring hospitalization is defined as an event that meets the following criteria: i. Requires hospitalization AND ii. Clinical symptoms of heart failure AND iii. Physical signs of heart failure AND iv. Need for additional/increased therapy AND v. No other non-cardiac etiology (such as chronic obstructive pulmonary disease, hepatic cirrhosis, acute renal failure, or venous insufficiency) and no other cardiac etiology (such as pulmonary embolus, cor pulmonale, primary pulmonary hypertension, or congenital heart disease) for signs or symptoms are identified. | Postoperatively, minimum 2.5 year follow-up |
| Generic quality of life according to the Short Form Health Survey (SF-12v2) | Secondary outcomes for aim 2: The SF-12v12 measures eight dimensions of health: physical functioning, role limitations due to physical problems, bodily pain, vitality, general health perception, social function, role limitations due to emotional problems, and mental health. Scores for each domain range from 0 to 100 with higher scores indicating better health status. The SF-12v2 has two summary measures: physical and mental self-perceived health with norm-based methods that standardize the score to a mean of 50 and standard deviation of 10. | Postoperatively, minimum 2.5 year follow-up |
| Generic quality of life according to EuroQuol-5D (EQ-5D) | Secondary outcomes for aim 2: EQ-5D is a five-item instrument to assess health status in the following five dimensions: mobility, self-care, usual activity, pain or discomfort, and anxiety or depression. Individual domain scores will be converted to a summary index representing utility weights, which allow conduct of cost-effectiveness analyses. | Postoperatively, minimum 2.5 year follow-up |
| Mental and physical health symptoms according to PROMIS instruments | Secondary outcomes for aim 2: Physical and mental health symptoms and physical functioning will be measured with standardized PROMIS instruments, including: Pain interference, Neuropathic Pain, Fatigue, Sleep disturbance, Depression, Anxiety, and Physical Function. A mean of 50 and a standard deviation of 10 represent the general population in the US. | Postoperatively, minimum 2.5 year follow-up |
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