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

This study has been withdrawn prior to enrollment.
(no patients enrolled)
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University
ClinicalTrials.gov Identifier:
NCT01156441
First received: June 30, 2010
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Mitral Regurgitation
Procedure: surgical mitral valve repair w/ mitral valve annuloplasty
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medical Versus Surgical Management of Patients With Moderate Mitral Regurgitation Following Percutaneous Coronary Intervention for Myocardial Infarction: A Pilot Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • patient survival [ Time Frame: baseline to 1 year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • congestive heart failure requiring hospitalization [ Time Frame: baseline and 1 year ] [ Designated as safety issue: Yes ]
    Hospitalization for congestive heart failure will be prospectively documented for all study subjects from recruitment through one year.

  • mitral regurgitation grade [ Time Frame: baseline and 1 year ] [ Designated as safety issue: Yes ]
    Transthoracic echocardiogram will be obtained to assess the presence and or severity of mitral regurgiation.

  • new atrial fibrillation [ Time Frame: baseline, 3 months, 6 months and 1 year ] [ Designated as safety issue: Yes ]
    EKG will be obtained during routine clinical follow up visits and at one year.

  • NYHA functional class [ Time Frame: baseline, 3 months, 6 months and 1 year ] [ Designated as safety issue: Yes ]
    This will be assessed via patient questionnaire using the standard NYHA classification.


Enrollment: 0
Study Start Date: July 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156441

Locations
United States, Illinois
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9638
Sponsors and Collaborators
Southern Illinois University
Investigators
Principal Investigator: Christina Vassileva, M.D. Southern Illinois University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT01156441     History of Changes
Other Study ID Numbers: VAS-SIU-10-003-1
Study First Received: June 30, 2010
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Illinois University:
Myocardial Infarction
Mitral Regurgitation
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Myocardial Infarction
Infarction
Mitral Valve Insufficiency
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Heart Valve Diseases

ClinicalTrials.gov processed this record on October 19, 2014