Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06104943 |
| Other study ID # |
K 2021-10399 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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.
