Cascade Testing In Identifying At-risk Family Members Of Individuals With Familial Hypercholesterolemia (FH) In PCP

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07653555
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cascade testing — OTHER
    Patient relatives will be contacted either directly or indirectly per patient preference: The indirect contact method provides patients with structured Mayo approved educational materials to support the index patient in accurate and consistent communication with relatives. Relatives have the option to contact the study team for cascade genetic testing. The direct contact method provides patients with a letter inviting relatives to contact the study team. After contact, relatives are offered educational materials and the opportunity for cascade genetic testing.
  • Standard of Care — OTHER
    No structured outreach is provided to patient or family members. Relatives may have their primary care provider refer them to genetic counseling services for cascade testing coordination.

Study Details

The purpose of this study is to evaluate the effectiveness of two models of cascade testing in identifying at-risk family members of individuals diagnosed with familial hypercholesterolemia (FH).

Key Dates

Start date
Jun 20, 2026
Status verified
Jun 2026
Primary completion
Jun 20, 2028
Completion
Sep 20, 2029

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Usual Care
    Patients will receive standard of care support
  • Experimental: Structured Outreach
    Patients and relatives will receive outreach in the form of direct or indirect contact

Primary Outcome Measure

Genetic testing among first- and second-degree relatives within 12 months of index patient enrollment [ Time Frame: 2 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Family Medicine Research Study Coordinators
[email protected]
507-422-6823
Elisa J. Houwink, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic in Rochester· Rochester, MN

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