Stockholm hyperTRIglyceridemia REGister (STRIREG) Study

Familial Hypertriglyceridemia Clinical Trial

— STRIREG  

Official title:

Stockholm hyperTRIglyceridemia REGister (STRIREG) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06104943
• Other study ID #: K 2021-10399
• Status: Active, not recruiting
• Start date: January 1, 2000
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: Region Stockholm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3607819
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Familial Hypertriglyceridemia
• Hyperlipoproteinemia Type IV
• Hypertriglyceridemia

Intervention

Other:
• Heredity for cardiovascular disease
First degree relatives with a diagnosis of Cardiovascular disease.
• Heredity for pancreatitis
First degree relatives with a diagnosis of pancreatitis.
• Heredity for type 2 diabetes
First degree relatives with a diagnosis of type 2 diabetes.
• Heredity for hypertriglyceridemia
First degree relatives with hypertriglyceridemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Stockholm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All cause mortality	Jan 1 2000 to Dec 31 2021
Primary	Cardiovascular mortality	Cardiovascular mortality	Jan 1 2000 to Dec 31 2021
Primary	Pancreatitis	Pancreatitis	Jan 1 2000 to Dec 31 2021
Primary	Major cardiovascular event (MACE)	Major cardiovascular event (MACE)	Jan 1 2000 to Dec 31 2021
Secondary	Myocardial infarction	Myocardial infarction	Jan 1 2000 to Dec 31 2021
Secondary	Stroke	Stroke	Jan 1 2000 to Dec 31 2021
Secondary	Peripheral artery disease	Peripheral artery disease	Jan 1 2000 to Dec 31 2021
Secondary	Type 2 diabetes	Type 2 diabetes	Jan 1 2000 to Dec 31 2021
Secondary	Cardiac revascularization	Cardiac revascularization	Jan 1 2000 to Dec 31 2021
Secondary	Non alcoholic fatty liver disease	Non alcoholic fatty liver disease	Jan 1 2000 to Dec 31 2021