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

June 12, 2014 updated by: Southern Illinois University

Medical Versus Surgical Management of Patients With Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention for Myocardial Infarction: A Pilot Prospective Randomized Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Mitral regurgitation (MR) is a frequent complication of myocardial infarction. Ischemic MR portends a poor prognosis on long term follow up. This pilot prospective randomized trial is a safety and feasibility trial to evaluate mitral valve repair versus surgical management in patients with residual MR after primary percutaneous coronary intervention (PCI). Patients will be screened for possible inclusion to identify those that have first MI treated with primary PCI. Patients with moderate MR at 6 or more weeks following first primary PCI will be randomized to continued medical management versus surgical mitral valve repair. Patients with previous or subsequent coronary artery bypass surgery and patients with severe ventricular dysfunction will be excluded. Patients will be followed for one year from the time of randomization. The safety and feasibility data will be used to design a large trial powered to detect a difference in mortality between treatment arms.

Results of this study could lead to a radical change in the treatment paradigm for patients with ischemic MR following PCI for acute MI. In addition, insight gained from this study could advance our understanding of the interrelationship between LV remodeling and MR and shed some light into the mechanism of ventricular function deterioration following MI. Moreover, it may provide a framework for the development of further recommendations with respect to the indications for surgical intervention in this patient population.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 62794-9638
        • Southern Illinois University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: surgical mitral valve repair
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

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.

Other Names:
  • mitral valve annuloplasty
NO_INTERVENTION: control: medical management
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient survival
Time Frame: baseline to 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
congestive heart failure requiring hospitalization
Time Frame: baseline and 1 year
Hospitalization for congestive heart failure will be prospectively documented for all study subjects from recruitment through one year.
baseline and 1 year
mitral regurgitation grade
Time Frame: baseline and 1 year
Transthoracic echocardiogram will be obtained to assess the presence and or severity of mitral regurgiation.
baseline and 1 year
new atrial fibrillation
Time Frame: baseline, 3 months, 6 months and 1 year
EKG will be obtained during routine clinical follow up visits and at one year.
baseline, 3 months, 6 months and 1 year
NYHA functional class
Time Frame: baseline, 3 months, 6 months and 1 year
This will be assessed via patient questionnaire using the standard NYHA classification.
baseline, 3 months, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Illinois University

Investigators

  • Principal Investigator: Christina Vassileva, M.D., Southern Illinois University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (ESTIMATE)

July 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAS-SIU-10-003-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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