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Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04124120
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : December 20, 2023
Sponsor:
Collaborators:
New York Presbyterian Hospital
Sunnybrook Health Sciences Centre
Cedars-Sinai Medical Center
Columbia University
Duke University
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Heart Diseases Coronary Artery Disease Coronary Artery Bypass Grafting Procedure: Single arterial graft Procedure: Multiple arterial grafting Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients undergoing coronary artery bypass surgery will be in one of two groups. One group will receive a single arterial graft and the second group will receive two or more arterial grafts.
Masking: Single (Outcomes Assessor)
Masking Description: The endpoint assessors will be blinded to treatment allocation (PROBE).
Primary Purpose: Treatment
Official Title: Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial
Actual Study Start Date : April 17, 2023
Estimated Primary Completion Date : March 2030
Estimated Study Completion Date : March 2030

Arm Intervention/treatment
Experimental: Single Arterial Graft (SAG) group
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.
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.

Experimental: Multiple Arterial Graft (MAG) group
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.
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.




Primary Outcome Measures :
  1. 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. [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]
    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.

  2. Primary outcome for aim 2: Disease-specific quality of life [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]

    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.



Secondary Outcome Measures :
  1. Death from any cause, any stroke, non-procedural myocardial infarction, and repeat revascularization. [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]

    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.


  2. Death from cardiac cause, any stroke, non-procedural myocardial infarction, repeat revascularization and hospital readmission for acute coronary syndrome or heart failure. [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]
    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.

  3. Death from any cause [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]
    Another secondary outcome for aim 1: Death will be considered to be cardiac unless a definite non-cardiac cause is identified.

  4. Stroke [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]

    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.

  5. Non-procedural myocardial infarction [ Time Frame: > 48 hours postoperatively, minimum 2.5 year follow-up ]

    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.

  6. Repeat revascularization [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]
    Another secondary outcome for aim 1: Repeat revascularization will include any percutaneous or surgical revascularization on a grafted coronary artery after the initial operation.

  7. Readmission for acute coronary syndrome [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]
    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.

  8. Readmission for heart failure [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]

    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.


  9. Generic quality of life according to the Short Form Health Survey (SF-12v2) [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]

    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.


  10. Generic quality of life according to EuroQuol-5D (EQ-5D) [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]
    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.

  11. Mental and physical health symptoms according to PROMIS instruments [ Time Frame: Postoperatively, minimum 2.5 year follow-up ]
    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.


Other Outcome Measures:
  1. Other recorded outcomes (safety endpoints) [ Time Frame: Within 30 days of surgery or during index hospitalization, whichever is longer. ]
    30-day mortality and major postoperative complications (revision for bleeding, perioperative MI (<48 hours after surgery), need for dialysis, need for tracheostomy, and surgical site complications).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women patients ≥18 years old.
  2. Isolated coronary artery bypass grafting.
  3. Primary (first time) cardiac surgery procedure.
  4. 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.

Exclusion Criteria:

  • Male gender
  • Single graft
  • Emergency operation
  • Myocardial infarction within 72 hours of surgery
  • Left ventricular ejection fraction < 35%
  • Any concomitant cardiac or non-cardiac procedure
  • Previous cardiac surgery
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124120


Contacts
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Contact: Mario Gaudino, Prof/PhD/MD 212.746.1812 mfg9004@med.cornell.edu
Contact: Stephen Fremes, Prof/MD 1 416 480 6073 stephen.fremes@sunnybrook.ca

Locations
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Sponsors and Collaborators
Weill Medical College of Cornell University
New York Presbyterian Hospital
Sunnybrook Health Sciences Centre
Cedars-Sinai Medical Center
Columbia University
Duke University
Investigators
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Principal Investigator: Mario Gaudino, Prof/PhD/MD Weill Medical College of Cornell University
Principal Investigator: Stephen Fremes, MD Sunnybrook Health Sciences Centre
Principal Investigator: Ruth Masterson Creber, RN, PhD Columbia University
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai
Principal Investigator: Karla Ballman, PhD Weill Medical College of Cornell University
Principal Investigator: Sean O'Brien, PhD Duke University
Publications:
Hillis LD, Smith PK, Anderson JL, Bittl JA, Bridges CR, Byrne JG, Cigarroa JE, Disesa VJ, Hiratzka LF, Hutter AM Jr, Jessen ME, Keeley EC, Lahey SJ, Lange RA, London MJ, Mack MJ, Patel MR, Puskas JD, Sabik JF, Selnes O, Shahian DM, Trost JC, Winniford MD; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American Association for Thoracic Surgery; Society of Cardiovascular Anesthesiologists; Society of Thoracic Surgeons. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 Dec 6;58(24):e123-210. doi: 10.1016/j.jacc.2011.08.009. Epub 2011 Nov 7. No abstract available.

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04124120    
Other Study ID Numbers: 1703018094-ROMA-Women
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Primary outcome data under request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: From publication until the third year after publication
Access Criteria: Research scope

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Heart Diseases
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases