Ignite Creation Date:
2024-05-05 @ 9:05 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00806988
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2008-12-10
Brief Title:
Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting CABG Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Surgical Interventions for Moderate Ischemic Mitral Regurgitation
Status:
COMPLETED
Status Verified Date:
2017-04
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:
None
Brief Summary:
Coronary artery bypass grafting CABG is a procedure that people with coronary artery disease CAD may undergo to increase blood flow to the heart During a CABG procedure people who have a leak in one of the valves in the heart-the mitral valve-may at the same time undergo a procedure that repairs the valve This study will evaluate whether people with moderate mitral valve leakage would be better off undergoing CABG plus the mitral valve repair procedure or undergoing CABG alone
Detailed Description:
CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup In severe cases CAD can cause chest pain shortness of breath and heart attack CABG is one treatment option for people with CAD During a CABG procedure a healthy artery or vein from another part of the body is connected to the blocked coronary artery Blood flow is then routed around the blockage to the heart
After a heart attack some people may have a leak in the mitral valve of the heart This condition is known as ischemic mitral regurgitation IMR and is associated with poor health outcomes including worsening heart failure In people with severe mitral valve leakage the CABG procedure and a mitral valve repair procedure are routinely performed together however in people with only moderate valve leakage there is no consensus in the medical community as to whether the mitral valve repair procedure is beneficial at the time of CABG The purpose of this study is to determine whether people with moderate mitral valve regurgitation should undergo a mitral valve repair procedure in addition to CABG or undergo CABG alone
This study will enroll people with CAD who require a CABG procedure and have moderate mitral regurgitation At a baseline study visit participants will undergo a physical examination blood collection neurocognitive tests and questionnaires regarding medical history medication history and quality of life In the operating room participants will be randomly assigned to undergo either CABG surgery and the mitral valve repair procedure or only CABG surgery Blood urine and tissue samples may be collected from participants after the surgery this is optional and will only be done with prior approval from participants All participants will attend study visits at Months 6 12 and 24 At each visit participants will take part in a medication history review a physical examination an echocardiogram a cardiopulmonary exercise test neurocognitive tests and quality of life surveys
After a heart attack some people may have a leak in the mitral valve of the heart This condition is known as ischemic mitral regurgitation IMR and is associated with poor health outcomes including worsening heart failure In people with severe mitral valve leakage the CABG procedure and a mitral valve repair procedure are routinely performed together however in people with only moderate valve leakage there is no consensus in the medical community as to whether the mitral valve repair procedure is beneficial at the time of CABG The purpose of this study is to determine whether people with moderate mitral valve regurgitation should undergo a mitral valve repair procedure in addition to CABG or undergo CABG alone
This study will enroll people with CAD who require a CABG procedure and have moderate mitral regurgitation At a baseline study visit participants will undergo a physical examination blood collection neurocognitive tests and questionnaires regarding medical history medication history and quality of life In the operating room participants will be randomly assigned to undergo either CABG surgery and the mitral valve repair procedure or only CABG surgery Blood urine and tissue samples may be collected from participants after the surgery this is optional and will only be done with prior approval from participants All participants will attend study visits at Months 6 12 and 24 At each visit participants will take part in a medication history review a physical examination an echocardiogram a cardiopulmonary exercise test neurocognitive tests and quality of life surveys
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 594 | OTHER | Ct Surgery Network Research Group | httpsreporternihgovquickSearchU01HL088942 |
| U01HL088942 | NIH | None | None |