Clinical trial NCT04929457: Evaluation of a Digiphysical Screening Method to Identify and Diagnose Familial Hypercholesterolemia
Official title: Evaluation of Digiphysical Screening for Familial Hypercholesterolemia - Efficacy of Digiphysical Screening, Effects on Cardiovascular Morbidity and Mortality and Health Economic Aspects
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Familial Hypercholesterolemia
Hypercholesterolemia
Keywords: familial hypercholesterolemia
cardiovascular disease
coronary artery disease
ischemic stroke
peripheral artery disease
hypercholesterolemia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All individuals that partake in the Swedish national digiphysical screening program for Familial Hypercholesterolemia will be asked to give personal informed consent to participate in the longitudinal observational cohort study.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Swedish personal identification number

Exclusion Criteria:

* Decline informed consent

Primary outcomes:
measure: Cardiovascular disease burden in patients with newly diagnosed Familial Hypercholesterolemia
timeFrame: Through study completion, until 2041.
measure: Change in cardiovascular disease burden in patients with diagnosed Familial Hypercholesterolemia
timeFrame: Through study completion, until 2041.
measure: Impact of mutation positive Familial Hypercholesterolemia on cardiovascular disease burden
timeFrame: Through study completion, until 2041.
measure: Comparison of cardiovascular disease burden between patients with diagnosed Familial Hypercholesterolemia and individuals aquitted from the diagnose
timeFrame: Through study completion, until 2041.
Secondary outcomes:
measure: Key efficacy numbers and ratios of screened and diagnosed for the digiphysical screening method to diagnose Familial Hypercholesterolemia
timeFrame: Through study completion, until 2041.
measure: Health economic aspects of the digiphysical screening method to diagnose Familial Hypercholesterolemia
timeFrame: Through study completion, until 2041.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska university hospital
Study officials:
affiliation: Dept. of Medicine Huddinge H7, Karolinska Institute, Stockholm
name: Jonas Brinck, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: