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Long Term Follow Up for CTSN Mitral Valve Repair Studies

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03066050
First Posted: February 28, 2017
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  Purpose
This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about patients' health 5-10 years after their mitral valve surgeries. The investigators will collect long-term health information on SMR and MMR trial participants using electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases.

Condition Intervention
Mitral Valve Insufficiency Coronary Artery Disease Other: MV Repair Other: MV Replacement Other: CABG

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: Long-Term Follow-Up For Participants Of: Evaluation Of Outcomes Following Mitral Valve Repair/Replacement In SMR and Surgical Interventions For MMR Trials

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Survival [ Time Frame: up to 10 years post-surgery (at the time of registry data transfer) ]
    All-cause mortality will be assessed.


Secondary Outcome Measures:
  • Repeat Cardiac Interventions for MR [ Time Frame: up to 10 years post-surgery (at the time of registry data transfer) ]
    Repeat cardiac interventions for MR in particular will be determined for the duration of follow-up and will be analyzed using a time-to-event analysis.

  • Hospital Costs [ Time Frame: up to 10 years post-surgery (at the time of registry data transfer) ]
    Hospital costs will be calculated for the duration of follow-up utilizing the minimum PHI necessary to link the CTSN databases to other databases (e.g., Vizient, CMS Medicare, and Canadian Province databases). Cost data will be extracted from the Vizient operational database system for member sites or national payer or state-wide databases. Dates of charges and revenue codes will be used to match the cost data with data on readmissions. We will estimate costs including center-specific ratios of cost to charges. These ratios will be based on the annual Medicare costs reports submitted annually by participating study sites to Medicare. These data will be used to impute data for patients treated at hospitals, which are non-Vizient members.

  • Cost Effectiveness [ Time Frame: up to 10 years post-surgery (at the time of registry data transfer) ]
    Cost Effectiveness using Incremental Cost Effectiveness Ratio and Net Health Benefit parameters. The primary objective of the cost-effectiveness analysis (CEA) is to estimate the incremental cost-effectiveness ratio (ICER) of the intervention under investigation as compared to the study-defined alternative. This ratio measures the ratio of the difference in costs and outcomes between the two study arms for each trial, with outcomes measured as life-years. We will also compute net health benefits (NHB) as an alternative way of looking at cost-effectiveness. This parameter compares the incremental effectiveness of an intervention with the minimum health effect that society would demand in return for the investment; i.e., with the health produced by investing at the societal ceiling cost-effectiveness ratio.


Estimated Enrollment: 469
Actual Study Start Date: May 3, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SMR MV Repair
This group of patients had been randomized in the SMR study to mitral valve repair with annuloplasty ring.
Other: MV Repair
Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Other Name: Mitral Valve Repair
MV Replacement
This group of patients had been randomized in the SMR study to mitral valve replacement.
Other: MV Replacement
Participants underwent mitral valve replacement and complete preservation of the sub-valvular apparatus.
Other Name: Mitral Valve Replacement
MMR MV Repair
This group of patients had been randomized in the MMR study to mitral valve repair with annuloplasty ring.
Other: MV Repair
Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Other Name: Mitral Valve Repair
CABG
This group of patients had been randomized in the MMR study to receive CABG
Other: CABG
Participants underwent coronary artery bypass grafting
Other Name: Coronary Artery Bypass Grafting

Detailed Description:

This study is a continuation of two CTSN randomized trials --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- for the purpose of assessing the long-term outcomes of the index surgical therapies. Key clinical outcomes will be collected utilizing electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases. Extended follow-up data will be obtained on up to 199 SMR and 270 MMR trial participants, who were alive at their 2-year follow-up evaluation. Patients will be followed for a minimum of 5 years and up to 10 years after randomization (the time of index surgical procedure). This follow-up data collection will be conducted by the Cardiothoracic Surgical Trials Network (CTSN) primarily utilizing the minimal PHI necessary to link data obtained from the MMR and SMR trials to other healthcare- and/or vital status-related databases.

Because the design of surgical trials for ischemic mitral regurgitation that would use mortality as a primary endpoint requires the enrollment of thousands of patients, the selected primary endpoint for the CTSN SMR and MMR trials was an echocardiographic measure of left ventricular remodeling. Secondary endpoints included, among others, survival, adverse events, readmissions and costs over a 2-year period. The SMR trial showed no difference in left ventricular reverse remodeling, but the rate of moderate or severe mitral regurgitation recurrence was significantly higher with mitral valve repair, resulting in more heart failure-related adverse events and cardiovascular admissions. Longer-term follow-up will be critical to assess whether this observed trend amongst SMR patients will continue and whether a survival difference will manifest over time. In moderate ischemic mitral regurgitation, mitral valve repair provided a more durable correction of mitral regurgitation than coronary artery bypass grafting (CABG) alone, but repair did not improve survival or reduce overall adverse events or readmissions, and was associated with an early hazard of neurological and supraventricular arrhythmic events. Longer-term follow-up of MMR patients will provide insights into whether the higher degree of recurrent mitral regurgitation with CABG alone will be associated with differences in adverse events, readmissions and survival. Additionally, the benefits of alternative surgical treatments for ischemic mitral regurgitation, which have differential upfront risks and costs, will likely extend beyond 2 years. Cost-effectiveness analysis will delineate the long-term cost-benefit trade-offs between mitral valve repair versus replacement for SMR, and of CABG with repair versus CABG alone for MMR, which should inform surgical decision making, and examine how differences in life expectancy and risk profiles of different patient groups affect cost-effectiveness over time. This extended follow-up should provide important clinical and health policy insights.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention
Criteria

Inclusion Criteria:

  • Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention

Exclusion Criteria:

  • Patients participating in the MMR and SMR trials who withdrew consent prior to the 2-year follow-up evaluation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066050


  Show 24 Study Locations
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Annetine C Gelijns, PhD Icahn School of Medicine at Mount Sinai
Study Chair: Richard Weisel, MD Toronto General Hospital
  More Information

Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03066050     History of Changes
Other Study ID Numbers: GCO 08-1078-00012
U01HL088942 ( U.S. NIH Grant/Contract )
First Submitted: February 2, 2017
First Posted: February 28, 2017
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Ischemic Mitral Regurgitation
Mitral Valve Disease
Moderate Mitral Regurgitation
Severe Mitral Regurgitation

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