Ignite Creation Date:
2024-05-06 @ 1:46 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04124120
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2019-10-10
Brief Title:
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women ROMAWomen Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROMAWomen
Brief Summary:
The central hypothesis of ROMAWomen 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 ROMAWomen 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 2000 women randomized 11 to MAG or SAG 690 from the parent ROMA trial 1310 from ROMAWomen 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 ROMAWomen increasing efficiency and reducing enrollment time
Hypothesis 10 MAG will reduce the incidence of major adverse cardiac and cerebrovascular events
Hypothesis 11 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 11 to MAG or SAG including those enrolled in ROMAQOL Differences by important subgroups as defined above will also be evaluated
Hypothesis 20 MAG will improve generic and disease-specific QOL compared to SAG
Hypothesis 21 MAG will improve physical and mental health symptoms compared to SAG
Hypothesis 22 The improvement with MAG will be consistent across key subgroups
The specific aims of ROMAWomen 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 2000 women randomized 11 to MAG or SAG 690 from the parent ROMA trial 1310 from ROMAWomen 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 ROMAWomen increasing efficiency and reducing enrollment time
Hypothesis 10 MAG will reduce the incidence of major adverse cardiac and cerebrovascular events
Hypothesis 11 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 11 to MAG or SAG including those enrolled in ROMAQOL Differences by important subgroups as defined above will also be evaluated
Hypothesis 20 MAG will improve generic and disease-specific QOL compared to SAG
Hypothesis 21 MAG will improve physical and mental health symptoms compared to SAG
Hypothesis 22 The improvement with MAG will be consistent across key subgroups
Detailed Description:
ROMAWomen will leverage the infrastructure and the existing women population of the ROMA trial ROMAWomen 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 2000 women randomized 11 to MAG or SAG 690 from the parent ROMA trial 1310 from ROMAWomen 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 11 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
ROMAWomen is a two-arm international multi-center randomized clinical trial nested in the ROMA trial ROMAWomen 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 processespersonnel network of participating sites site PIs and study coordinators The planned randomization procedure interventions and treatment arms outcome assessments and follow-up protocol of ROMAWomen 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 ROMAWomen
ROMAWomen is a two-arm international multi-center randomized clinical trial nested in the ROMA trial ROMAWomen 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 processespersonnel network of participating sites site PIs and study coordinators The planned randomization procedure interventions and treatment arms outcome assessments and follow-up protocol of ROMAWomen 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 ROMAWomen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None