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Trial record 20 of 256 for:    "methodist hospital" | Recruiting, Not yet recruiting, Available Studies | Houston

Effect of MitraClip on Acute and Chronic Reverse Cardiac Remodeling Assessed by CMR: The MITRA-REVERSE Study (MITRA-REV)

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ClinicalTrials.gov Identifier: NCT02924363
Recruitment Status : Recruiting
First Posted : October 5, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Piedmont Heart Institute, Inc., Atlanta, GA
Information provided by (Responsible Party):
Dipan Shah, The Methodist Hospital System

Brief Summary:
The purpose of this study is to use cardiac magnetic resonance (CMR) and echocardiography to define the anatomic and functional remodeling that results from MitraClip implantation. A total of sixty (60) patients undergoing MitraClip implantation will be enrolled across multiple sites. The severity of mitral regurgitation, cardiac morphology and function will be assessed in these patients by taking cardiac magnetic resonance imaging with an FDA approved contrast agent at BASELINE (within 30 days prior to MitraClip implantation), during the ACUTE REMODELING PHASE (pre-discharge following implantation), and during the CHRONIC REMODELING PHASE (6 months post-implantation).

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Diagnostic Test: Cardiac MRI with or without contrast dye Diagnostic Test: Blood sample Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants undergoing cardiac magnetic imaging resonance scanning with an FDA cleared MRI and with or without an FDA approved contrast dye.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of MitraClip on Reverse Cardiac Remodeling Assessed by CMR and Echocardiography: The MITRA-REVERSE Study A Prospective Multicenter Study
Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Single arm (cardiac MRI & hematocrit blood sample)
Patients will undergo a pre- & post- MitraClip procedure cardiac magnetic resonance imaging (CMR) scan with an FDA cleared MRI scanner and with or without an FDA approved contrast dye. The scan and the blood draw to assess the hematocrit is research, the MitraClip procedure is standard of care for these patients.
Diagnostic Test: Cardiac MRI with or without contrast dye
MRI scans of the heart are performed before and after the MitraClip clinical procedure with an FDA cleared device with or without an FDA approved contrast dye.

Diagnostic Test: Blood sample
Blood samples collected to calculate hematocrit for measurements of the CMR extracellular matrix.
Other Name: phlebotomy, Complete Blood Count (CBC) for hematocrit value




Primary Outcome Measures :
  1. Ventricular remodeling [ Time Frame: baseline comparison to 6 month scan ]
    Serial CMR scans obtained to document changes in the ventricular remodeling



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females, 18 years of age or older.
  2. Negative pregnancy test (serum or urine β-HCG) within 24 hours of gadolinium contrast administration, if female and of child-bearing potential. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study (this applies only to patients in the gadolinium sub-study).
  3. Symptomatic severe mitral regurgitation (grade 3-4+).
  4. Undergoing MitraClip implantation due to increased surgical risk.
  5. Patients or legally authorized representatives who have the ability to understand the requirements of the study and provide written consent/assent to participate and agree to abide by the study requirements.

Exclusion Criteria:

  1. The patient is enrolled in the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial (COAPT).
  2. The patient is scheduled to undergo percutaneous coronary intervention with MitraClip procedure.
  3. The patient has Stage D Congestive Heart Failure or inability to lay flat for 60 minutes.
  4. The patient has a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up.
  5. The patient has contraindications to CMR, including:

    1. Implanted defibrillator or pacemaker that is not MRI conditional
    2. Epicardial pacemaker leads, or any abandoned leads
    3. Ferromagnetic aneurysm clip
    4. Ferromagnetic halo device
    5. Cochlear implants
    6. Implanted infusion pumps
    7. Severe claustrophobia
    8. Any other conditions which represent contraindication to CMR.
  6. The patient is clinically unstable

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): NCT02924363


Contacts
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Contact: Mohamad G Ghosn, PhD 713-441-9837 mghosn@houstonmethodist.org

Locations
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United States, Georgia
Piedmont Heart Institute Active, not recruiting
Atlanta, Georgia, United States, 30309
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Mohamad Ghosn, PhD    713-441-9837    mghosn@houstonmethodist.org   
Principal Investigator: Dipan J Shah, MD         
Sponsors and Collaborators
Dipan Shah
Piedmont Heart Institute, Inc., Atlanta, GA
Investigators
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Principal Investigator: Dipan J Shah, MD The Methodist Hospital System

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Responsible Party: Dipan Shah, Dipan J. Shah, MD, Director Cardiovascular MRI Laboratory, Houston Methodist DeBakey Heart & Vascular Center (HMDHVC), The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT02924363     History of Changes
Other Study ID Numbers: Pro00013041
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dipan Shah, The Methodist Hospital System:
Cardiac Magnetic Resonance
Mitra Clip
Mitral Valve

Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases