Stockholm hyperTRIglyceridemia REGister (STRIREG) Study (STRIREG)

The STRIREG study is a retrospective longitudinal general population-based register study including all individuals who had had at least one plasma Tg measurement between 1st January 2000 and 31st December 2021 at Karolinska University Laboratory or Unilabs AB in Region Stockholm (population 2.41 million 2021). The exclusion criteria were a lack of a unique Swedish personal identification number (PIN). The index population consisted of 1,460,184 individuals between the age 0 and 107 years. The index population was extended to form the complete cohort (n=3,607,819) by associating the parents and the siblings (n=2,147,635) to the indexes by interlinkage of personal identification numbers via the Multi-Generation register (see below).

The study baseline for the index population was defined as the date for participant's first Tg measurement.

Study Overview

• Status: Active, not recruiting
• Conditions: Familial Hypertriglyceridemia
• Intervention / Treatment: Other: Heredity for cardiovascular disease; Other: Heredity for pancreatitis; Other: Heredity for type 2 diabetes; Other: Heredity for hypertriglyceridemia

Detailed Description

Hypertriglyceridemia (hTG) is associated with atherosclerotic cardiovascular disease, pancreatitis, and non-alcoholic fatty liver disease in large population-based studies. Less is known about the impact on hereditary hTG and cardiometabolic disease status for the development of hTG and its associated cardiometabolic outcomes. hTG remains a target for lipid lowering therapies and with new pharmacological interventions being developed, there is a need to identify patients that will benefit most from treatment with these new medicines.

The population-based observational Stockholm hyperTRIglyceridemia REGister (STRIREG) study include 1,460,184 index individuals that have measured plasma triglycerides in the clinical routine in Region Stockholm, Sweden, between 1st January 2000 and 31st December 2021. The laboratory measurements also included basic haematology, blood lipid panel, liver function tests and HbA1c. Using the Swedish Multi-Generation register, 2,147,635 parents and siblings to the indexes were identified to form the complete study cohort. Laboratory data from participants were combined with data from several national registers that provided information on cause of death, medical diagnoses, dispensed medicines, and socioeconomic factors including country of birth, education level and marital status.

The multigenerational longitudinal STRIREG cohort provides a unique opportunity to investigate different aspects of familial hTG as well as heredity for other metabolic diseases. Important outcome measures include mortality, cardiovascular mortality, major cardiovascular events, development of incident diabetes, and non-alcoholic fatty liver disease. The STRIREG study will provide a deeper understanding of the impact of heredity on hTG and associated cardiometabolic complications.

• Study Type: Observational
• Enrollment (Actual): 3607819

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Populationbased cohort originating from Stockholm County. with all individuals who had had at least one plasma Triglyceride measurement between 1st January 2000 and 31st December 2021 at Karolinska University Laboratory or Unilabs AB in Stockholm County Sweden. The first degree relatives are parents and siblings to the index patients identified through the Swedish Multi-Generation Register.

Description

Inclusion Criteria: All individuals who had had at least one plasma Triglyceride measurement between 1st January 2000 and 31st December 2021 at Karolinska University Laboratory or Unilabs AB in Stockholm County Sweden.

Exclusion Criteria: No Swedish social security number.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Index patients; All individuals who had had at least one plasma Triglyceride measurement between 1st January 2000 and 31st December 2021 at Karolinska University Laboratory or Unilabs AB in Stockholm County in Sweden.	Other: Heredity for cardiovascular disease; First degree relatives with a diagnosis of Cardiovascular disease.; Other: Heredity for pancreatitis; First degree relatives with a diagnosis of pancreatitis.; Other: Heredity for type 2 diabetes; First degree relatives with a diagnosis of type 2 diabetes.; Other: Heredity for hypertriglyceridemia; First degree relatives with hypertriglyceridemia
First degree relatives to index patients; Parents and the siblings to the index patients by interlinkage of personal identification numbers via the Swedish Multi-Generation register.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All cause mortality	Jan 1 2000 to Dec 31 2021
Cardiovascular mortality	Cardiovascular mortality	Jan 1 2000 to Dec 31 2021
Pancreatitis	Pancreatitis	Jan 1 2000 to Dec 31 2021
Major cardiovascular event (MACE)	Major cardiovascular event (MACE)	Jan 1 2000 to Dec 31 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarction	Myocardial infarction	Jan 1 2000 to Dec 31 2021
Stroke	Stroke	Jan 1 2000 to Dec 31 2021
Peripheral artery disease	Peripheral artery disease	Jan 1 2000 to Dec 31 2021
Type 2 diabetes	Type 2 diabetes	Jan 1 2000 to Dec 31 2021
Cardiac revascularization	Cardiac revascularization	Jan 1 2000 to Dec 31 2021
Non alcoholic fatty liver disease	Non alcoholic fatty liver disease	Jan 1 2000 to Dec 31 2021

Collaborators and Investigators

• Sponsor: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): December 31, 2021
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Hypertriglyceridemia; Hyperlipoproteinemia Type IV
• Other Study ID Numbers: K 2021-10399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No