Stockholm hyperTRIglyceridemia REGister (STRIREG) Study

Sponsor
Region Stockholm (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06104943
Collaborator
(none)
3,607,819
336

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
3607819 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Stockholm hyperTRIglyceridemia REGister (STRIREG) Study
Actual Study Start Date :
Jan 1, 2000
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Mortality [Jan 1 2000 to Dec 31 2021]

    All cause mortality

  2. Cardiovascular mortality [Jan 1 2000 to Dec 31 2021]

    Cardiovascular mortality

  3. Pancreatitis [Jan 1 2000 to Dec 31 2021]

    Pancreatitis

  4. Major cardiovascular event (MACE) [Jan 1 2000 to Dec 31 2021]

    Major cardiovascular event (MACE)

Secondary Outcome Measures

  1. Myocardial infarction [Jan 1 2000 to Dec 31 2021]

    Myocardial infarction

  2. Stroke [Jan 1 2000 to Dec 31 2021]

    Stroke

  3. Peripheral artery disease [Jan 1 2000 to Dec 31 2021]

    Peripheral artery disease

  4. Type 2 diabetes [Jan 1 2000 to Dec 31 2021]

    Type 2 diabetes

  5. Cardiac revascularization [Jan 1 2000 to Dec 31 2021]

    Cardiac revascularization

  6. Non alcoholic fatty liver disease [Jan 1 2000 to Dec 31 2021]

    Non alcoholic fatty liver disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Region Stockholm

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Region Stockholm
ClinicalTrials.gov Identifier:
NCT06104943
Other Study ID Numbers:
  • K 2021-10399
First Posted:
Oct 27, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2023