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Surgical Interventions for Moderate Ischemic Mitral Regurgitation
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), November 2008
First Received: February 5, 2009   Last Updated: April 3, 2009   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00838786
  Purpose

The research activities in this protocol are meant to support the multicenter CSTN (Cardiothoracic Surgical Trials Network) protocol, Surgical Interventions for Moderate Ischemic Mitral Regurgitation which is being conducted at Suburban Hospital. This protocol deals with only the research studies being conducted at the NIH Clinical Center. Patients undergoing surgery at the NIH Heart Center at Suburban Hospital will be recruited for this study. The Principal Investigator there is Dr. Keith Horvath and the majority of procedures will be performed at Suburban Hospital and monitored by the Suburban Hospital Institutional Review Board (IRB). The preoperative and follow-up echo and cardiopulmonary stress tests on enrolled patients, however, will be performed at the NIH Clinical Center and will be described in detail by this protocol. In addition, to ensure consistency of data quality, NIH staff will be assisting with the acquisition of the intro-operative echo studies at Suburban Hospital.

The overall objective of this study is to evaluate the safety and efficacy of mitral valve repair (MVR) for moderate ischemic mitral regurgitation.

Specifically, this study compares mitral valve repair combined with coronary artery bypass grafting (CABG) to coronary artery bypass grafting alone in this patient population. Patients will be randomly assigned (1:1) to CABG + MVR or CABG alone.

...


Condition Intervention Phase
Coronary Artery Disease
Mitral Regurgitation
Procedure: CABG
Procedure: MVR
Phase II

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Surgical Interventions for Moderate Ischemic Mitral Regurgitation

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To evaluate the safety and efficacy of mitral valve repair for moderate ischemic mitral regurgitation.

Secondary Outcome Measures:
  • To assess the impact of CABG alone and CABG plus mitral valve repair on the target population in the following areas: cardiac performance, mortality, adverse events, quality of life, functional status, presence and severity of MR, health resource use

Estimated Enrollment: 10
Study Start Date: January 2009
Intervention Details:
    Procedure: CABG
    N/A
    Procedure: MVR
    N/A
Detailed Description:

The research activities in this protocol are meant to support the multicenter CSTN (Cardiothoracic Surgical Trials Network) protocol, Surgical Interventions for Moderate Ischemic Mitral Regurgitation which is being conducted at Suburban Hospital. This protocol deals with only the research studies being conducted at the NIH Clinical Center. Patients undergoing surgery at the NIH Heart Center at Suburban Hospital will be recruited for this study. The Principal Investigator there is Dr. Keith Horvath and the majority of procedures will be performed at Suburban Hospital and monitored by the Suburban Hospital Institutional Review Board (IRB). The preoperative and follow-up echo and cardiopulmonary stress tests on enrolled patients, however, will be performed at the NIH Clinical Center and will be described in detail by this protocol. In addition, to ensure consistency of data quality, NIH staff will be assisting with the acquisition of the intro-operative echo studies at Suburban Hospital.

The overall objective of this study is to evaluate the safety and efficacy of mitral valve repair (MVR) for moderate ischemic mitral regurgitation.

Specifically, this study compares mitral valve repair combined with coronary artery bypass grafting (CABG) to coronary artery bypass grafting alone in this patient population. Patients will be randomly assigned (1:1) to CABG + MVR or CABG alone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

The patient population for this trial consists of adult patients with moderate ischemic mitral regurgitation and clinically significant coronary artery disease with a clinical indication for coronary artery bypass grafting (CABG). All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity. All patients enrolled in the treatment study will undergo preoperative echocardiogram and cardiopulmonary stress testing at the NIH Clinical Center through the current protocol.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838786

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
Study ID Numbers: 090050, 09-H-0050
Study First Received: February 5, 2009
Last Updated: April 3, 2009
ClinicalTrials.gov Identifier: NCT00838786     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Ischemic Mitral Regurgitation
Coronary Artery Disease
Coronary Artery Bypass Grafting
Left Ventricular Remodeling
Coronary Artery Disease
Coronary Artery Bypass Grafting
Mitral Valve

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease
Heart Valve Diseases
Mitral Valve Insufficiency

ClinicalTrials.gov processed this record on May 06, 2009