Ignite Creation Date:
2024-05-06 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03217006
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2017-07-06
Brief Title:
Randomization of Single vs Multiple Arterial Grafts
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts the ROMA Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
ROMA
Brief Summary:
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 andor 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 4300 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 11 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
Prospective event-driven unblinded randomized multicenter trial of at least 4300 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 11 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
Detailed Description:
In the 1980s it was recognized that long-term survival was enhanced in patients undergoing coronary surgery when the left anterior descending LAD was grafted with a left internal thoracic artery ITA rather than a saphenous vein 1 This difference was predicated at least in part due to greater and more durable patency of the left ITA compared to an increased early occlusion rate and later progressive atherosclerosis of saphenous vein grafts SVG 2
For more than 20 years it has generally been accepted that patients who receive multiple arterial grafts AGs at the time of coronary artery bypass surgery CABG have increased postoperative survival compared to those who receive only one AG especially over the long term 3-5 The current United States and European Guidelines encourage the use of AGs in patients with a long life expectancy 6 7 Last year a position paper from the Society of Thoracic Surgeons strongly recommended a wider use of AGs 8
The putative mechanism underlying the AG hypothesis is greater patency In line with the original findings of improved LAD graft patency with ITA vs SVG data from randomized control trials RCTs as well as observational studies and a network meta-analysis 9 have demonstrated that the patency of the RA as well as the right ITA exceed that of a SVG providing mechanistic basis to support the AG hypothesis
ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause any stroke post discharge myocardial infarction andor repeat revascularization The trial is powered to detect a 20 relative reduction in the primary outcome with 90 power at 5 alpha
The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of a two or more AGs 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 andor repeat revascularization
The secondary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more AGs compared to a single arterial graft is associated with improved survival
For more than 20 years it has generally been accepted that patients who receive multiple arterial grafts AGs at the time of coronary artery bypass surgery CABG have increased postoperative survival compared to those who receive only one AG especially over the long term 3-5 The current United States and European Guidelines encourage the use of AGs in patients with a long life expectancy 6 7 Last year a position paper from the Society of Thoracic Surgeons strongly recommended a wider use of AGs 8
The putative mechanism underlying the AG hypothesis is greater patency In line with the original findings of improved LAD graft patency with ITA vs SVG data from randomized control trials RCTs as well as observational studies and a network meta-analysis 9 have demonstrated that the patency of the RA as well as the right ITA exceed that of a SVG providing mechanistic basis to support the AG hypothesis
ROMA is a two arm event driven randomized multi-centre trial aimed at evaluating the impact of the use of one ITA vs two or more AGs for CABG on a composite of death from any cause any stroke post discharge myocardial infarction andor repeat revascularization The trial is powered to detect a 20 relative reduction in the primary outcome with 90 power at 5 alpha
The primary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of a two or more AGs 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 andor repeat revascularization
The secondary aim is to conduct a multicenter international randomized control trial to test the hypothesis that the use of two or more AGs compared to a single arterial graft is associated with improved survival
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01HL152021-01 | NIH | None | httpsreporternihgovquickSearch1R01HL152021-01 |