Cascade Genetic Testing of Familial Hypercholesterolemia (CATCH)
Primary Purpose
Familial Hypercholesterolemia
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
web-based centralized service and message
Sponsored by
About this trial
This is an interventional screening trial for Familial Hypercholesterolemia
Eligibility Criteria
Inclusion Criteria:
- patients with severe hypercholesterolemia and familial or personal history of early-onset cardiovascular disease = Dutch Lipid Clinic Network score (DLNC) >= 6 points.
Exclusion Criteria:
- Patients without at least one contactable first-degree family members
Sites / Locations
- Center for primary care and public health (Unisanté), University of LausanneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
Monogenic positive FH, direct contact
Monogenic positive FH, usual care
Monogenic negative FH, direct contact
Monogenic negative FH, usual care
Arm Description
Outcomes
Primary Outcome Measures
the yield of detection of familial hypercholesterolemia (FH)
The yield of detection is the number of test performed/number of contactable relatives.
Secondary Outcome Measures
Full Information
NCT ID
NCT04419090
First Posted
June 3, 2020
Last Updated
May 18, 2022
Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborators
Swiss Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04419090
Brief Title
Cascade Genetic Testing of Familial Hypercholesterolemia
Acronym
CATCH
Official Title
Cascade Genetic Testing of Familial Hypercholesterolemia: the CATCH Multicenter Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborators
Swiss Heart Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Familial hypercholesterolemia (FH) is a frequent genetic disorder (1/200) associated with an increased risk of early-onset myocardial infarction. To improve detection and treatment of patient with FH, cascade genetic testing in families is recommended by many cardiovascular prevention guidelines. However, the implementation of national genetic cascade screening is challenging, because legal protection to guarantee privacy of data do not authorize physicians to directly contact at-risk relatives. Using current mobile information technologies and a centralized web-based platform, we designed an ethical genetic cascade screening program for FH to be tested in Switzerland.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypercholesterolemia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monogenic positive FH, direct contact
Arm Type
Experimental
Arm Title
Monogenic positive FH, usual care
Arm Type
No Intervention
Arm Title
Monogenic negative FH, direct contact
Arm Type
Experimental
Arm Title
Monogenic negative FH, usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
web-based centralized service and message
Intervention Description
Perform three cycles of cascade screening through several generation of family members of an index case. The contact of relatives will be initiated by the index case and supported by a web-based centralized service. The index case will be provided with a prepared email or Whatsapp message that the index case can further forward to his first-degree relatives. The email/message will contain a link to a secured web application with a code for the connection. By clicking on the link, the relative will connect to a specifically designed app. The app will provide information about the transmission mode of FH, the cardiovascular risk associated with FH and the way how to reduce this risk. The relative can then fill out information and provide agreement to be contacted for the study. The nearest specialized clinic will then contact the relative to organize further screening with similar processes.
Primary Outcome Measure Information:
Title
the yield of detection of familial hypercholesterolemia (FH)
Description
The yield of detection is the number of test performed/number of contactable relatives.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with severe hypercholesterolemia and familial or personal history of early-onset cardiovascular disease = Dutch Lipid Clinic Network score (DLNC) >= 6 points.
Exclusion Criteria:
Patients without at least one contactable first-degree family members
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Nanchen, MD
Phone
+41213146107
Email
david.nanchen@unisante.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Nanchen, MD
Organizational Affiliation
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for primary care and public health (Unisanté), University of Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Nanchen, MD
Email
david.nanchen@unisante.ch
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Cascade Genetic Testing of Familial Hypercholesterolemia
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