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PRecIsion Medicine in CardiomyopathY (PRIMaCY)

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ClinicalTrials.gov Identifier: NCT04036799
Recruitment Status : Active, not recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborators:
Stanford University
Children's Hospital of Philadelphia
New York Presbyterian Hospital
University of Texas Southwestern Medical Center
University of Michigan
Children's Hospital Medical Center, Cincinnati
Provincial Health Services Authority
Stollery Children's Hospital
Children's Hospital of Eastern Ontario
The Royal Children's Hospital Melbourne
Children's Healthcare of Atlanta
Primary Children's Hospital
Medical University of South Carolina
Boston Children’s Hospital
Texas Children's Hospital
The Cleveland Clinic
Monroe Carell Jr. Children's Hospital at Vanderbilt
Children's Hospital Colorado
Indiana University Health
OHSU Doernbecher Children's Hospital
Children's Hospital Los Angeles
Information provided by (Responsible Party):
Seema Mital, The Hospital for Sick Children

Brief Summary:
This is a retrospective cohort study of pediatric hypertrophic cardiomyopathy (HCM) patients using chart and registry review methodology. The studies objective is to develop and validate a sudden cardiac death (SCD) risk calculator that is age-appropriate for children with HCM that includes clinical and genetic factors.

Condition or disease
Hypertrophic Cardiomyopathy Sudden Cardiac Death

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development of a Risk Calculator to Predict Sudden Cardiac Death in Children With Hypertrophic Cardiomyopathy
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Group/Cohort
Hypertrophic Cardiomyopathy



Primary Outcome Measures :
  1. Number of participants with a composite sudden cardiac death event [ Time Frame: Time to sudden cardiac death event within 5 years from first evaluation. ]
    The composite SCD event includes post diagnosis SCD, aborted SCD (including ventricular fibrillation, sustained ventricular tachycardia), primary ICD insertion with appropriate shock, secondary ICD insertion



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals meeting eligibility criteria at first presentation were included.
Criteria

Inclusion Criteria:

  • phenotype-positive patients diagnosed with hypertrophic cardiomyopathy
  • phenotype-negative, genotype positive patients considered at risk for developing hypertrophic cardiomyopathy

Exclusion Criteria:

  • Neuromuscular, metabolic, syndromic (other than Noonan Syndrome and related RAS-opathies) or endocrine (including infants of diabetic mothers) causes of HCM
  • (Other treatable causes of left ventricular hypertrophy (systemic hypertension, anatomic defects causing left ventricular outflow tract obstruction e.g. aortic stenosis, subAS, subaortic membrane, coarctation)

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Responsible Party: Seema Mital, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04036799     History of Changes
Other Study ID Numbers: 1000055819
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seema Mital, The Hospital for Sick Children:
Pediatric
Risk Prediction
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Death, Sudden, Cardiac
Death
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Heart Arrest
Death, Sudden