Clinical Trial of the Sequence of Cardiovascular Genetic Counseling and Testing
NCT ID: NCT05422573
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
510 participants
INTERVENTIONAL
2022-12-20
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Standard of care
Pre-test genetic counseling appointment with results returned by phone or EHR. Post-test appointment available upon request.
No interventions assigned to this group
Efficiency
Pre-test genetics education by educational video with an OPTIONAL call with a genetic counselor to address questions. Pre-test appointment available by request. Post-test genetic counseling appointment.
post-test cardiovascular genetic counseling with pre-test education by video
post-test cardiovascular genetic counseling with pre-test education by video
optional phone call with genetic counselor pre-test
OPTIONAL phone call with genetic counselor pre-test
Flipped
Pre-test genetics education by educational video with a REQUIRED call with a genetic counselor to address questions. Pre-test appointment available by request. Post-test genetic counseling appointment.
post-test cardiovascular genetic counseling with pre-test education by video
post-test cardiovascular genetic counseling with pre-test education by video
required phone call with genetic counselor pre-test
REQUIRED phone call with genetic counselor pre-test.
Interventions
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post-test cardiovascular genetic counseling with pre-test education by video
post-test cardiovascular genetic counseling with pre-test education by video
required phone call with genetic counselor pre-test
REQUIRED phone call with genetic counselor pre-test.
optional phone call with genetic counselor pre-test
OPTIONAL phone call with genetic counselor pre-test
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis or suspected clinical diagnosis of a potentially inherited cardiovascular disease including a) hypertrophic, dilated, or arrhythmogenic cardiomyopathy, b) ventricular or atrial arrhythmias or an ECG-pattern suspicious for an inherited cardiovascular disease including catecholaminergic polymorphic ventricular tachycardia, long QT syndrome, or Brugada syndrome, or c) a diagnosed or suspected lipid disorder or early-onset coronary artery disease,
3. next-generation cardiovascular sequencing panel clinically indicated.
1. Adult (age 18+) scheduled for outpatient genetic counseling in the Johns Hopkins Center for Inherited Heart Diseases,
2. Documented pathogenic or likely pathogenic variant in a gene associated with a hereditary cardiomyopathy, arrhythmia syndrome, or lipid disease in a family member,
3. Referred to the Center for Inherited Heart Diseases for family-specific variant testing.
Exclusion Criteria
2. Previous genetic testing that definitively identified the genetic cause of the patient's condition,
3. Patient unable to speak or read English,
4. Genetic counseling appointment is not anticipated to include genetic testing (for instance if it was scheduled to discuss family communication or adaptation to a new diagnosis),
5. Next generation sequencing panel not clinically indicated (panel cohort only).
18 Years
ALL
No
Sponsors
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National Human Genome Research Institute (NHGRI)
NIH
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Cynthia James
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00320656
Identifier Type: -
Identifier Source: org_study_id
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