Familial HypertriglyceridemiaSTRIREGNCT06104943
Stockholm hyperTRIglyceridemia REGister (STRIREG) Study
An observational study of Familial Hypertriglyceridemia, run by Region Stockholm.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Familial Hypertriglyceridemia
- What is being tested?
- Heredity for cardiovascular disease, Heredity for pancreatitis and Heredity for type 2 diabetes
- How many people
- 3,607,819 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 31 Dec 2027
- How long will I take part?
- 21 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
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.
About this 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.
Read the 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.
- Conditions
- Familial Hypertriglyceridemia
- Being tested
- Heredity for cardiovascular disease, Heredity for pancreatitis, Heredity for type 2 diabetes, Heredity for hypertriglyceridemia
- Medical subject headings
- Hyperlipoproteinemia Type IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heredity for cardiovascular diseaseOther
First degree relatives with a diagnosis of Cardiovascular disease.
Heredity for pancreatitisOther
First degree relatives with a diagnosis of pancreatitis.
Heredity for type 2 diabetesOther
First degree relatives with a diagnosis of type 2 diabetes.
Heredity for hypertriglyceridemiaOther
First degree relatives with hypertriglyceridemia
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Heredity for cardiovascular disease; Other: Heredity for pancreatitis; Other: Heredity for type 2 diabetes; Other: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All cause mortality
Measured: Jan 1 2000 to Dec 31 2021
Cardiovascular mortality
Cardiovascular mortality
Measured: Jan 1 2000 to Dec 31 2021
Pancreatitis
Pancreatitis
Measured: Jan 1 2000 to Dec 31 2021
Major cardiovascular event (MACE)
Major cardiovascular event (MACE)
Measured: Jan 1 2000 to Dec 31 2021
Secondary outcomes (6)
Myocardial infarction
Myocardial infarction
Measured: Jan 1 2000 to Dec 31 2021
Stroke
Stroke
Measured: Jan 1 2000 to Dec 31 2021
Peripheral artery disease
Peripheral artery disease
Measured: Jan 1 2000 to Dec 31 2021
Type 2 diabetes
Type 2 diabetes
Measured: Jan 1 2000 to Dec 31 2021
Cardiac revascularization
Cardiac revascularization
Measured: Jan 1 2000 to Dec 31 2021
Non alcoholic fatty liver disease
Non alcoholic fatty liver disease
Measured: Jan 1 2000 to Dec 31 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Jan 2000
- Primary completion31 Dec 2021
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,607,819 participants (actual)
- Target duration
- 21 Years
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104943
- Sponsor's protocol ID
- K 2021-10399
- Acronym
- STRIREG
- Status last verified
- Sep 2023
- First submitted
- 23 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stockholm hyperTRIglyceridemia REGister (STRIREG) Study
- ClinicalTrials.gov ID
- NCT06104943
- Acronym / sponsor ID
- STRIREG / K 2021-10399
- Conditions
- Familial Hypertriglyceridemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,607,819 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 21 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Index patients | – | Other: Heredity for cardiovascular disease, Other: Heredity for pancreatitis, Other: Heredity for type 2 diabetes, Other: Heredity for hypertriglyceridemiaAll 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heredity for cardiovascular diseaseFirst degree relatives with a diagnosis of Cardiovascular disease. | Other | Index patients |
| Heredity for pancreatitisFirst degree relatives with a diagnosis of pancreatitis. | Other | Index patients |
| Heredity for type 2 diabetesFirst degree relatives with a diagnosis of type 2 diabetes. | Other | Index patients |
| Heredity for hypertriglyceridemiaFirst degree relatives with hypertriglyceridemia | Other | Index patients |
Primary outcome
Mortality
Time frame: Jan 1 2000 to Dec 31 2021
All cause mortality
Cardiovascular mortality
Time frame: Jan 1 2000 to Dec 31 2021
Cardiovascular mortality
Pancreatitis
Time frame: Jan 1 2000 to Dec 31 2021
Pancreatitis
Major cardiovascular event (MACE)
Time frame: Jan 1 2000 to Dec 31 2021
Major cardiovascular event (MACE)
6 secondary outcomes
Myocardial infarction
Time frame: Jan 1 2000 to Dec 31 2021
Stroke
Time frame: Jan 1 2000 to Dec 31 2021
Peripheral artery disease
Time frame: Jan 1 2000 to Dec 31 2021
Type 2 diabetes
Time frame: Jan 1 2000 to Dec 31 2021
Cardiac revascularization
Time frame: Jan 1 2000 to Dec 31 2021
Non alcoholic fatty liver disease
Time frame: Jan 1 2000 to Dec 31 2021
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hypertriglyceridemia, run by Region Stockholm.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Jan 1 2000 to Dec 31 2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.