NCT00693134

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
Last Updated

June 6, 2008

Status Verified

February 1, 2008

Enrollment Period

2.3 years

First QC Date

June 4, 2008

Last Update Submit

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

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy tissue, if available.

MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Officials

  • Tia A Tortoriello-Raymond, MD

    University of Texas - Southwestern Medical Center, Children's Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations