Medical Versus Surgical Management of Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention

NCT01156441 | Withdrawn Phase 1

• 1 other identifier: VAS-SIU-10-003-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The pilot prospective randomized trial is designed to determine the safety and feasibility of enrolling patients to surgically correct residual Mitral Regurgitation (MR) following Percutaneous Coronary Intervention (PCI) for Myocardial Infarction (MI) verses ongoing medical management of MR. The investigators hypothesize that if moderate MR is corrected in this patient subset, the patients will have improved outcomes as measured by decreased number of major adverse cardiac events, including death, congestive heart failure requiring hospitalization, atrial fibrillation, deterioration of New York Heart Association (NYHA) functional status and improved quality of life.

Conditions

Myocardial Infarction; Mitral Regurgitation

Keywords

Myocardial Infarction; Mitral Regurgitation; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• patient survival

  Patient survival will be prospectively documented for all study subjects from recruitment through one year. A stopping rule for the surgical arm is a pre-specified cut-off of 5% based on the method proposed by Kramar and Bascoul-Mollevi in "Early Stopping Rules in Clinical Trials Based on Sequential Monitoring of Serious Adverse Events" \[39\]. A data and safety monitoring board (DSMB) that includes five independent investigators and a statistician has been established to conduct ongoing study review to maintain safety of all participants.

  baseline to 1 year

Secondary Outcomes (4)

• congestive heart failure requiring hospitalization

  baseline and 1 year

• mitral regurgitation grade

  baseline and 1 year

• new atrial fibrillation

  baseline, 3 months, 6 months and 1 year

• NYHA functional class

  baseline, 3 months, 6 months and 1 year

Study Arms (2)

surgical mitral valve repair

EXPERIMENTAL

Non-invasive transesophageal echocardiography will be performed on all study volunteers to determine if the individual has mitral regurgitation and, if so, to what degree. Mitral valve repair will be performed with mitral valve annuloplasty via median sternotomy, utilizing cardiopulmonary bypass and moderate hypothermia.

Procedure: surgical mitral valve repair w/ mitral valve annuloplasty

control: medical management

NO INTERVENTION

Clinical observation will be continued without surgery. Non-invasive transesophageal echocardiography will be performed on all study volunteers to determine if the individual has mitral regurgitation and, if so, to what degree.

Interventions

surgical mitral valve repair w/ mitral valve annuloplasty PROCEDURE

Mitral valve repair will be performed via median sternotomy, utilizing cardiopulmonary bypass and moderate hypothermia. The mitral valve will be approached through a left atrial incision. Following inspection of the valve, mitral valve annuloplasty will be accomplished with a complete semi-rigid annuloplasty ring. Additional techniques to address residual regurgitation will be at the discretion of the surgeon. The left atriotomy will then be closed and the patient weaned off and separated from the cardiopulmonary bypass. Intraoperative transesophageal echocardiography will be performed on all study volunteers.

Also known as: mitral valve annuloplasty

surgical mitral valve repair

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone PCI for first acute MI (index MI) since 7/1/09 at MMC and STJ
• documented moderate mitral regurgitation on follow up echocardiography six or more weeks after PCI procedure
• English speaking

You may not qualify if:

• CABG after PCI for acute MI
• History of previous MI prior to index MI
• History of previous PCI or CABG prior to index PCI
• EF \<30 % on the echocardiogram at 6 weeks after PCI for MI

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Southern Illinois University School of Medicine

Springfield, Illinois, 62794-9638, United States

Location

Related Publications (1)

• Vassileva CM, Boley T, Markwell S, Hazelrigg S. Meta-analysis of short-term and long-term survival following repair versus replacement for ischemic mitral regurgitation. Eur J Cardiothorac Surg. 2011 Mar;39(3):295-303. doi: 10.1016/j.ejcts.2010.06.034. Epub 2010 Aug 19.

  PMID: 20727782 BACKGROUND

Related Links

• Southern Illinois University School of Medicine website

MeSH Terms

Conditions

Myocardial Infarction; Mitral Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Christina Vassileva, M.D.

  Southern Illinois University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 2, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

US (1)