Acute Myocardial InfarctionNCT03258983
Alpha-linolenic Acid and the Risk of ASCVD
An observational study of Acute Myocardial Infarction and Ischemic Stroke, run by Aalborg University Hospital.
Trial summary
Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial infarction, ischemic stroke and peripheral artery disease. However, the results of previous studies have been inconsistent. Read more about this study
- Who is it for?
- Ages 50 to 64 years
- Conditions the study is for
- Acute Myocardial Infarction, Ischemic Stroke, Peripheral Artery Disease
- What is being tested?
- Alpha-linolenic acid
- How many people
- 57,053 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 1993to 10 Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 64 years
- All sexes
- Adult
Study population: The Diet, Cancer and Health cohort was established over a period of 3.5 years between 1993 and 1997 by inviting 160,725 men and women to participate. All eligible participants were native Danish citizens without a previous diagnosis of cancer, aged 50-64 years, and living in the areas of Copenhagen and Aarhus. A total of 57053 accepted to participate in the Diet, Cancer and Health cohort study. A subcohort of 3500 participants were drawn randomly from the cohort at baseline.
Who may be able to join
- Born in Denmark
- Age between 50 and 64 years
- Living in the areas of Copenhagen and Aarhus
Who cannot join
- Previous cancer
About this study
Official title: Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease
Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial infarction, ischemic stroke and peripheral artery disease. However, the results of previous studies have been inconsistent.
Objectives: To investigate the associations between dietary intake of ALA, adipose tissue content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.
Read more
Methods: This project will be based on data from the Danish cohort study Diet, Cancer and Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary intake of ALA will be assessed using a validated semiquantitative food-frequency questionnaire and adipose tissue content will be determined with the use of gas chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed information on lifestyle factors, medical history and anthropometri was collected at baseline.
Incident cases have been identified through national registries and the diagnoses have previously been validated.
Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas analyses on adipose tissue content of ALA will be analysed based on a case-cohort design. Hazard ratioes with 95% confidence intervals will be used to describe the associations between the exposure variables and the outcome variables of interest.
- Being tested
- Alpha-linolenic acid
- Keywords
- Alpha-linolenic acid, Dietary intake, Adipose tissue, Nutritional epidemiology
- Medical subject headings
- Ischemic Stroke, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-linolenic acidOther
Also called ALA (18:3-n3)
Exposure to dietary intake of alpha-linolenic acid (ALA) will be assessed using a detailed food frequency questionaire filled in by participants included in the Diet, Cancer and Health cohort at baseline. Exposure to adipose tissue content of ALA will be determined by gas chromatography in all incident cases and in subcohort of 3500 participants randomly drawn from the total cohort.
| Study group | Role | What they receive |
|---|---|---|
| The Diet, Cancer and Health cohort | Not described Receives: Other: Alpha-linolenic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident acute myocardial infarction
Measured: From baseline until July 2013
Incident ischemic stroke including total and subtypes of ischemic stroke
Measured: From baseline until November 2009
Incident peripheral artery disease
Measured: From baseline until December 2009
Secondary outcomes (1)
Incident fatal myocardial infarction
Measured: From baseline until July 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start24 Nov 1993
- Primary completion10 Jul 2013
- Study completion10 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- 57,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Responsible party
- Principal investigator, Christian Sørensen Bork, Aalborg University Hospital
- Investigators
- Christian S Bork, MD, Principal investigator, Department of Cardiology, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258983
- Sponsor's protocol ID
- 17-R115-A7415-22060 - 2016-229
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.
PubMed 17786808Bork CS, Veno SK, Lundbye-Christensen S, Jakobsen MU, Tjonneland A, Schmidt EB, Overvad K. Dietary Intake of alpha-Linolenic Acid Is Not Appreciably Associated with Risk of Ischemic Stroke among Middle-Aged Danish Men and Women. J Nutr. 2018 Jun 1;148(6):952-958. doi: 10.1093/jn/nxy056.
PubMed 29767732
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-linolenic Acid and the Risk of Atherosclerotic Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03258983
- Acronym / sponsor ID
- 17-R115-A7415-22060 - 2016-229
- Keywords
- Alpha-linolenic acid, Dietary intake, Adipose tissue, Nutritional epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57,053 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- 24 Nov 1993 (actual)
- Primary completion
- 10 Jul 2013 (actual)
- Study completion
- 10 Jul 2013 (actual)
- First posted
- 23 Aug 2017 (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.
Background: The plant-derived omega-3 fatty acid alpha-linolenic acid (ALA, 18:3-n-3) may reduce the risk of atherosclerotic cardiovascular disease, including incident myocardial infarction, ischemic stroke and peripheral artery disease. However, the results of previous studies have been inconsistent.
Objectives: To investigate the associations between dietary intake of ALA, adipose tissue content of ALA, and the risk of the major atherosclerotic cardiovascular diseases incident myocardial infarction, ischemic stroke and subtypes, and peripheral artery disease.
Methods: This project will be based on data from the Danish cohort study Diet, Cancer and Health which consisted of 57,053 men and women at recruitment between 1993 and 1997. Dietary intake of ALA will be assessed using a validated semiquantitative food-frequency questionnaire and adipose tissue content will be determined with the use of gas chromatography analyses of adipose tissue biopsies collected at baseline. Also, detailed information on lifestyle factors, medical history and anthropometri was collected at baseline.
Incident cases have been identified through national registries and the diagnoses have previously been validated.
Analyses of dietary intake of ALA will be analysed using a traditional cohort design, whereas analyses on adipose tissue content of ALA will be analysed based on a case-cohort design. Hazard ratioes with 95% confidence intervals will be used to describe the associations between the exposure variables and the outcome variables of interest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The Diet, Cancer and Health cohort | – | Other: Alpha-linolenic acid |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Age groups
- Adult
- Study population
- The Diet, Cancer and Health cohort was established over a period of 3.5 years between 1993 and 1997 by inviting 160,725 men and women to participate. All eligible participants were native Danish citizens without a previous diagnosis of cancer, aged 50-64 years, and living in the areas of Copenhagen and Aarhus. A total of 57053 accepted to participate in the Diet, Cancer and Health cohort study. A subcohort of 3500 participants were drawn randomly from the cohort at baseline.
Key inclusion criteria (3 listed)
- Born in Denmark
- Age between 50 and 64 years
- Living in the areas of Copenhagen and Aarhus
Key exclusion criteria (1 listed)
- Previous cancer
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 |
|---|---|---|
| Alpha-linolenic acidAlso: ALA (18:3-n3)Exposure to dietary intake of alpha-linolenic acid (ALA) will be assessed using a detailed food frequency questionaire filled in by participants included in the Diet, Cancer and Health cohort at baseline. Exposure to adipose tissue content of ALA will be determined by gas chromatography in all incident cases and in subcohort of 3500 participants randomly drawn from the total cohort. | Other | The Diet, Cancer and Health cohort |
Primary outcome
Incident acute myocardial infarction
Time frame: From baseline until July 2013
Incident ischemic stroke including total and subtypes of ischemic stroke
Time frame: From baseline until November 2009
Incident peripheral artery disease
Time frame: From baseline until December 2009
1 secondary outcome
Incident fatal myocardial infarction
Time frame: From baseline until July 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Background: PubMed 17786808Tjonneland A, Olsen A, Boll K, Stripp C, Christensen J, Engholm G, Overvad K. Study design, exposure variables, and socioeconomic determinants of participation in Diet, Cancer and Health: a population-based prospective cohort study of 57,053 men and women in Denmark. Scand J Public Health. 2007;35(4):432-41. doi: 10.1080/14034940601047986.
- Derived from this study: PubMed 29767732Bork CS, Veno SK, Lundbye-Christensen S, Jakobsen MU, Tjonneland A, Schmidt EB, Overvad K. Dietary Intake of alpha-Linolenic Acid Is Not Appreciably Associated with Risk of Ischemic Stroke among Middle-Aged Danish Men and Women. J Nutr. 2018 Jun 1;148(6):952-958. doi: 10.1093/jn/nxy056.
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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.
Christian S Bork, MD principal investigator
Department of Cardiology, Aalborg University Hospital, Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Ischemic Stroke, run by Aalborg University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incident acute myocardial infarction (time frame: From baseline until July 2013). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258983, which also lists 2 linked publications.
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 23 Aug 2017.