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
1 other identifier
observational
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2004
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedJune 6, 2008
February 1, 2008
2.3 years
June 4, 2008
June 5, 2008
Conditions
Outcome Measures
Primary Outcomes (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.
Study Arms (2)
Myocarditis Patients
Patients initially diagnosed with myocarditis.
Control Patients
Patients with no known cardiomyopathies
Eligibility Criteria
Inpatients of the Cardiac Service at Children's Medical Center.
You may qualify if:
- \. Evidence from diagnostic tests and physical exam that confirm inflammatory cardiomyopathy.
You may not qualify if:
- Patients with structural heart disease other than septal defects or patent ductus arteriosus
- Patients with history of arrhythmia
- Patients with history of ventricular dysfunction diagnosed by echocardiograms
- Patients with history of chronic systemic illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Medical Center
Dallas, Texas, 75235, United States
Biospecimen
Biopsy tissue, if available.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tia A Tortoriello-Raymond, MD
University of Texas - Southwestern Medical Center, Children's Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
March 1, 2004
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
June 6, 2008
Record last verified: 2008-02