Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03525041
Status:
UNKNOWN
Last Update Posted:
2018-05-15
First Post:
2018-04-29
Brief Title:
Mitral Valve Repair Combined Coronary Artery Bypass GraftingCABG Verus CABG Alone on Functional Ischemic Mitral Regurgitation
Sponsor:
Beijing Anzhen Hospital
Organization:
Beijing Anzhen Hospital
Study Overview
Official Title:
The Randomly Controlled Trial of Optimal Surgical Method for CAD Patients Combined Moderate Functional Ischemic Mitral Regurgitation
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
RECRUITING
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 graftingCABG is an effective procedure in treating severe coronary artery diseaseCAD Optimal surgical method for CAD patients with functional ischemic mitral regurgitationFIMR is still controversial This study will evaluate the different effectiveness of CABG plus mitral valve annuloplasty versus CABG alone on patients with moderate FIMR
Detailed Description:
CAD is a severe health problem worldwide It is a result of plaque buildup and eventually leads to the reduction of blood supply on myocardium CABG is one of the procedure to improve symptoms caused by myocardial ischemia And it is especially effective in treating severe coronary artery disease
FIMR is one of the most common complications of CAD After acute myocardial infarction FIMR will occur in 17-55 patients and 3-19 of them will develop into moderate or severe MR eventually FIMR is an important prognostic factor of CAD the in-hospital mortality rate of patients with IMR is significantly higher in several studies In patients with mild MR CABG alone is enough to improve myocardial ischemia however in people with moderate mitral regurgitation there is still a dispute on whether mitral valve annuloplasty is beneficial at the time of CABG The purpose of this study is to determine the optimal surgical procedure of CAD patients combined moderate FIMR
This study will compare the effectiveness of different surgical procedure on people with moderate FIMR by enrolling people with enrolling people with CAD who require CABG procedure and have moderate mitral regurgitation At baseline study a questionnaire will be assigned to undergo either CABG surgery of CABG plus mitral calve annuloplasty Blood urine and tissue samples will be collected after the surgery All participants will be followed up at month 13612 participants will take part in a medication history review a physical examination a blood collection to evaluate the brain natriuretic peptide and an echocardiogram
FIMR is one of the most common complications of CAD After acute myocardial infarction FIMR will occur in 17-55 patients and 3-19 of them will develop into moderate or severe MR eventually FIMR is an important prognostic factor of CAD the in-hospital mortality rate of patients with IMR is significantly higher in several studies In patients with mild MR CABG alone is enough to improve myocardial ischemia however in people with moderate mitral regurgitation there is still a dispute on whether mitral valve annuloplasty is beneficial at the time of CABG The purpose of this study is to determine the optimal surgical procedure of CAD patients combined moderate FIMR
This study will compare the effectiveness of different surgical procedure on people with moderate FIMR by enrolling people with enrolling people with CAD who require CABG procedure and have moderate mitral regurgitation At baseline study a questionnaire will be assigned to undergo either CABG surgery of CABG plus mitral calve annuloplasty Blood urine and tissue samples will be collected after the surgery All participants will be followed up at month 13612 participants will take part in a medication history review a physical examination a blood collection to evaluate the brain natriuretic peptide and an echocardiogram
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 |
|---|---|---|---|
| Z151100003915084 | OTHER_GRANT | Beijing Municipal Science and Technology Commission | None |