Mitral Valve Repair Combined Coronary Artery Bypass Grafting(CABG) Verus CABG Alone on Functional Ischemic Mitral Regurgitation

NCT03525041 | Unknown

• 2 other identifiers: 2015217146Z151100003915084
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary artery bypass grafting(CABG) is an effective procedure in treating severe coronary artery disease(CAD). Optimal surgical method for CAD patients with functional ischemic mitral regurgitation(FIMR) is still controversial. This study will evaluate the different effectiveness of CABG plus mitral valve annuloplasty versus CABG alone on patients with moderate FIMR.

Conditions

Coronary Artery Disease; Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

• Left Ventricular End Systolic Volume Index (LVESVI)

  Measured at month 12

Secondary Outcomes (4)

• Operative death

  Measured during operation

• In-hospital death

  1 year

• Short-term complications

  Measured within 1 week after operation

• Rehospitalization

  1 year

Study Arms (2)

CABG+mitral valve annuloplasty

ACTIVE COMPARATOR

Participants will undergo CABG and mitral valve annuloplasty.

Procedure: CABG; Procedure: mitral valve annuloplasty

CABG

ACTIVE COMPARATOR

Participants will undergo CABG only.

Procedure: CABG

Interventions

CABG PROCEDURE

CABG will be performed using standard surgical techniques. All procedures will be performed with cardiopulmonary bypass(CPB). Saphenous vein(SV)will be used as conduit but harvesting methods will not be prescribed, and utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, judging by the surgical investigator.

CABG; CABG+mitral valve annuloplasty

mitral valve annuloplasty PROCEDURE

Surgical techniques for mitral valve annuloplasty may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation.

CABG+mitral valve annuloplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CAD that is amenable to CABG and a clinical indication for revascularization
• Moderate mitral regurgitation in the judgment of the clinical site echocardiographer, quantitative guidelines as proposed would be: jet area between 4 cmsq to 8 cmsq, jet area/left atrial area ratio between 20% to 39%
• Age ≥ 18 years
• Mitral valve annuloplasty is applicable

You may not qualify if:

• Organic mitral insufficiency caused by rupture of papillary muscle, rheumatic fever, degeneration or infectious endocarditis
• Jet area of mitral valve cannot be evaluated by echocardiogram
• In combination of other procedures such as surgery on tricuspid valve, aortic valve, congenital heart diseases or diseases of the thoracic arteries
• Prior surgical or percutaneous mitral valve repair
• Contraindication to cardiopulmonary bypass (CPB)
• Clinical signs of cardiogenic shock at the time of randomization
• Treatment with medication prior to the surgery
• Severe, irreversible pulmonary hypertension in the judgment of the investigator
• Evidence of cirrhosis or liver synthetic failure
• Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, in the judgment of the investigator

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Beijing Municipal Science & Technology Commission: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Ran Dong, MD

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Kui Zhang, MD

CONTACT

86-10-64456411; zhangkui725@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of ward No.11,cardiac surgery

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: May 15, 2018
• Study Start: May 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)