Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia

NCT ID: NCT04929457

Last Updated: 2023-03-16

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2033-09-30

Brief Summary

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Longitudinal and observational registry-based cohort study of individuals participating in the national digiphysical screening program for Familial Hypercholesterolemia. The information collected in the screening process will be combined in pseudo-anonymous form with data from the National Board of Health and Welfare (registries: Cause of Death, Diagnoses according to International Classification of Diseases (ICD) and Prescribed drugs) and Statistic Sweden (Longitudinal integrated database for health insurance and labour market studies). Primary analysis: association between Familial Hypercholesterolemia and cardiovascular disease. Secondary analysis: efficacy and health economic aspects of digiphysical screening for Familial Hypercholesterolemia.

Detailed Description

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Conditions

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Familial Hypercholesterolemia Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals screened for Familial Hypercholesterolemia

Individuals participating in diagnostic activities in the digiphysical health care screening program for Familial Hypercholesterolemia and have provided informed consent are included in the cohort.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Swedish personal identification number

Exclusion Criteria

* Decline informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Jonas Brinck

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonas Brinck, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Medicine Huddinge H7, Karolinska Institute, Stockholm

Locations

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Karolinska university hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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DigiLipids

Identifier Type: -

Identifier Source: org_study_id

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