Role of Matrix Metalloproteinases (MMPs) and Tissue Inhibitors of Metalloproteinases (TIMPs) in Children With Myocarditis

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00693134
Collaborator
(none)
36
1
28
1.3

Study Details

Study Description

Brief Summary

Children can have or develop certain problems with their heart function, specifically with the heart muscle or myocardium. This problem can be caused by many things specifically by infection resulting in myocarditis (inflammation of the heart muscle) or dilated cardiomyopathy (caused by many factors including high blood pressure and heart attacks). The body goes through many processes to repair the injured tissue including using proteins that cause the muscle mass to increase called matrix metalloproteinases (MMPs). The body also uses proteins that direct the MMPs to stop increasing the muscle mass called tissue inhibitory of metalloproteinases (TIMPs). Currently, there are no published studies that explain or evaluate the relationship that MMPs and TIMPs have in myocarditis and dilated cardiomyopathy in children.

The investigator wishes to perform a prospective study of the serum levels of these proteins and their regulators in children with myocarditis and/or dilated cardiomyopathy and compare them with children that have no heart disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All children who present with signs and symptoms of myocarditis and have laboratory findings consistent with cardiomyopathy will be eligible. After prospective consent, all subjects will receive: (1) a complete physical examination, (2) complete transthoracic echocardiogram to better characterize the disease process. Follow-up echocardiograms will be performed at 24-72 hours after admission into the protocol and at discharge from the hospital. Approximately 2 teaspoons of blood will be drawn at: (1) enrollment, (2) 24 hours after, (3) 72 hours after, (4) and at hospital discharge. Those subjects that receive a heart transplant will have blood drawn at the time of transplantation. For those that have a cardiac catheterization or have a muscle biopsy as part of their standard of care, will also have a biopsy of their right ventricle performed.

    Data to be collected: Minimum patient demographic data (age, sex, ethnic origin), vital signs, clinical course events/data (i.e. need for dialysis, length of stay, surgical time points, etc), diagnostic test results (EKGs, ECHOs, etc), significant medical history data, and standard of care laboratory results.

    The investigator wishes to evaluate the relationship of this data with the patient's diagnosis, clinical course, and serum levels of MMP and TIMP proteinases.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    36 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Role of Matrix Metalloproteinases and Tissue Inhibitors of Metalloproteinases in Children With Acute Inflammatory Cardiomyopathy
    Study Start Date :
    Mar 1, 2004
    Actual Primary Completion Date :
    Jul 1, 2006
    Actual Study Completion Date :
    Jul 1, 2006

    Arms and Interventions

    Arm Intervention/Treatment
    Myocarditis Patients

    Patients initially diagnosed with myocarditis.

    Control Patients

    Patients with no known cardiomyopathies

    Outcome Measures

    Primary Outcome Measures

    1. Determine correlation between proteinases (MMPs and TIMPs) and their regulators in children with acute inflammatory cardiomyopathy. [Length of hospital stay from time of admission to protocol.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Evidence from diagnostic tests and physical exam that confirm inflammatory cardiomyopathy.
    Exclusion Criteria:
    1. Patients with structural heart disease other than septal defects or patent ductus arteriosus

    2. Patients with history of arrhythmia

    3. Patients with history of ventricular dysfunction diagnosed by echocardiograms

    4. Patients with history of chronic systemic illness

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Medical Center Dallas Texas United States 75235

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center

    Investigators

    • Principal Investigator: Tia A Tortoriello-Raymond, MD, University of Texas - Southwestern Medical Center, Children's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00693134
    Other Study ID Numbers:
    • 012004-072
    First Posted:
    Jun 6, 2008
    Last Update Posted:
    Jun 6, 2008
    Last Verified:
    Feb 1, 2008
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 6, 2008