NCT06104943

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,607,819

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2000

Longer than P75 for all trials

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jan 2000Dec 2027

Study Start

First participant enrolled

January 1, 2000

Completed
22 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

October 27, 2023

Status Verified

September 1, 2023

Enrollment Period

22 years

First QC Date

October 23, 2023

Last Update Submit

October 23, 2023

Conditions

Familial Hypertriglyceridemia

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Myocardial infarction

    Jan 1 2000 to Dec 31 2021

  • Stroke

    Jan 1 2000 to Dec 31 2021

  • Peripheral artery disease

    Jan 1 2000 to Dec 31 2021

  • Type 2 diabetes

    Jan 1 2000 to Dec 31 2021

  • Cardiac revascularization

    Jan 1 2000 to Dec 31 2021

  • +1 more secondary outcomes

Study Arms (2)

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 diseaseOther: Heredity for pancreatitisOther: Heredity for type 2 diabetesOther: Heredity for 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.

Interventions

Heredity for cardiovascular diseaseOTHER

First degree relatives with a diagnosis of Cardiovascular disease.

Index patients
Heredity for pancreatitisOTHER

First degree relatives with a diagnosis of pancreatitis.

Index patients
Heredity for type 2 diabetesOTHER

First degree relatives with a diagnosis of type 2 diabetes.

Index patients
Heredity for hypertriglyceridemiaOTHER

First degree relatives with hypertriglyceridemia

Index patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperlipoproteinemia Type IV

Interventions

Heredity

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHypertriglyceridemia

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
21 Years
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 27, 2023

Study Start

January 1, 2000

Primary Completion

December 31, 2021

Study Completion (Estimated)

December 31, 2027

Last Updated

October 27, 2023

Record last verified: 2023-09