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

This study has been completed.
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00693134
First received: June 4, 2008
Last updated: June 5, 2008
Last verified: February 2008

June 4, 2008
June 5, 2008
March 2004
July 2006   (final data collection date for primary outcome measure)
Determine correlation between proteinases (MMPs and TIMPs) and their regulators in children with acute inflammatory cardiomyopathy. [ Time Frame: Length of hospital stay from time of admission to protocol. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00693134 on ClinicalTrials.gov Archive Site
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Role of Matrix Metalloproteinases (MMPs) and Tissue Inhibitors of Metalloproteinases (TIMPs) in Children With Myocarditis
The Role of Matrix Metalloproteinases and Tissue Inhibitors of Metalloproteinases in Children With Acute Inflammatory Cardiomyopathy

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Biopsy tissue, if available.

Non-Probability Sample

Inpatients of the Cardiac Service at Children's Medical Center.

Myocarditis
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  • Myocarditis Patients
    Patients initially diagnosed with myocarditis.
  • Control Patients
    Patients with no known cardiomyopathies
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
up to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00693134
012004-072
No
Tia Tortoriello-Raymond, MD, Universtty of Texas - Southwestern Medical Center
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Tia A Tortoriello-Raymond, MD University of Texas - Southwestern Medical Center, Children's Medical Center
University of Texas Southwestern Medical Center
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP