Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06104943

Stockholm hyperTRIglyceridemia REGister (STRIREG) Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Familial Hypertriglyceridemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn Hyperlipidemias Hyperlipoproteinemia Type IV Hyperlipoproteinemias Hypertriglyceridemia Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heredity for cardiovascular disease

Other

First degree relatives with a diagnosis of Cardiovascular disease.

Heredity for pancreatitis

Other

First degree relatives with a diagnosis of pancreatitis.

Heredity for type 2 diabetes

Other

First degree relatives with a diagnosis of type 2 diabetes.

Heredity for hypertriglyceridemia

Other

First degree relatives with hypertriglyceridemia

Primary outcomes

  1. Mortality

    Time frame: Jan 1 2000 to Dec 31 2021

    All cause mortality

  2. Cardiovascular mortality

    Time frame: Jan 1 2000 to Dec 31 2021

    Cardiovascular mortality

  3. Pancreatitis

    Time frame: Jan 1 2000 to Dec 31 2021

    Pancreatitis

  4. Major cardiovascular event (MACE)

    Time frame: Jan 1 2000 to Dec 31 2021

    Major cardiovascular event (MACE)

Secondary outcomes

  1. Myocardial infarction

    Time frame: Jan 1 2000 to Dec 31 2021

    Myocardial infarction

  2. Stroke

    Time frame: Jan 1 2000 to Dec 31 2021

    Stroke

  3. Peripheral artery disease

    Time frame: Jan 1 2000 to Dec 31 2021

    Peripheral artery disease

  4. Type 2 diabetes

    Time frame: Jan 1 2000 to Dec 31 2021

    Type 2 diabetes

  5. Cardiac revascularization

    Time frame: Jan 1 2000 to Dec 31 2021

    Cardiac revascularization

  6. Non alcoholic fatty liver disease

    Time frame: Jan 1 2000 to Dec 31 2021

    Non alcoholic fatty liver disease

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Acronym: STRIREG

Important dates

Study start
2000
Primary completion
2021
Study completion
2027
First posted
Oct 27, 2023
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.