Coronary Heart DiseaseP5NCT03650127
Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi FinTerveys Study
An observational study of Coronary Heart Disease and Type 2 Diabetes, run by Markus Perola at 1 site in Finland.
Trial summary
P5.fi study - P4 together with a fifth 'P' and '.fi' for population health Finally Implemented in Finland - studies the value of returning genetic and metabolomic risk information in two diseases (coronary heart disease and type 2 diabetes) and one feature (venous thromboembolism). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Type 2 Diabetes, Deep Vein Thrombosis
- How many people
- 3,449 participants
- Where
- 1 siteFinland
- Study dates
- 2 Feb 2018to 31 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population of FinHealth 2017 -study represent the general population of Finland. All participants are over 18 years of age and have been selected randomly from the population registry. All FinHealth 2017 participants with DNA sample and permission for a re-contact were invited to P5.fi study.
Who may be able to join
- Only participants of FinHealth 2017 -study are eligible for the study
Who cannot join
- Participants not part of FinHealth 2017 -study are not eligible
Trial locations and contacts
1 site in 1 country.
Finland1 site
National Institute of Health and Welfare
Helsinki, Uusimaa, 00271
About this study
Official title: Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi
P5.fi study - P4 together with a fifth 'P' and '.fi' for population health Finally Implemented in Finland - studies the value of returning genetic and metabolomic risk information in two diseases (coronary heart disease and type 2 diabetes) and one feature (venous thromboembolism). The hypothesis of the study is that 1) combining genetic and metabolic risk with traditional risk factors adds value to the personal risk assessment of these diseases, 2) such risk information can be provided to individuals using a web based user portal in an easily understandable and useful format, and 3) receiving genetic and metabolomic risk information has an effect on the health of the study participants.
The study is a continuation of FinHealth 2017 -study, which involved more than 7,000 Finns from around the country. The participants of FinHealth were invited to participate in P5.fi -study. The new research utilises information, samples, and measurements obtained in the FinHealth Study. Prospective clinical significance of selected genetic and metabolomic risk scores will be studied in 30.000 Finnish individuals. The study will analyze the genetic and metabolomic profile of the P5.fi participants and develop and test a protocol for returning them health related risk information. The impact of the intervention will by followed up by questionnaires and national health registers for five years.
- Keywords
- Genetic risk score, metabolic risk score, health promotion, web-based, intervention
- Medical subject headings
- Coronary Disease, Diabetes Mellitus, Type 2, Venous Thrombosis, Genetic Risk Score
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary heart disease/Type 2 diabetes/Venous thromboembolism diagnosis
Disease diagnosis observed from the national hospitalization and death registries.
Measured: Measure is assessed after a year from the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start2 Feb 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- 3,449 participants (actual)
Sponsor and investigators
- Lead sponsor
- Markus Perola
- Sponsor type
- Other government
- Collaborators
- University of Helsinki, Institute for Molecular Medicine
- Responsible party
- Sponsor-investigator, Markus Perola, Finnish Institute for Health and Welfare
- Investigators
- Markus Perola, MD, PhD, Principal investigator, National Institute of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650127
- Sponsor's protocol ID
- 1474/6.00.00/2018
- Acronym
- P5
- Status last verified
- Jan 2021
- First submitted
- 24 Aug 2018
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Returning Genome and Metabolome Data to FinTerveys 2017 Participants: P5.fi
- ClinicalTrials.gov ID
- NCT03650127
- Acronym / sponsor ID
- P5 / 1474/6.00.00/2018
- Keywords
- Genetic risk score, metabolic risk score, health promotion, web-based, intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,449 participants (actual)
- Lead sponsor
- Markus PerolaOther government
- Collaborators
- University of Helsinki, Institute for Molecular Medicine
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Aug 2018 (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.
P5.fi study - P4 together with a fifth 'P' and '.fi' for population health Finally Implemented in Finland - studies the value of returning genetic and metabolomic risk information in two diseases (coronary heart disease and type 2 diabetes) and one feature (venous thromboembolism). The hypothesis of the study is that 1) combining genetic and metabolic risk with traditional risk factors adds value to the personal risk assessment of these diseases, 2) such risk information can be provided to individuals using a web based user portal in an easily understandable and useful format, and 3) receiving genetic and metabolomic risk information has an effect on the health of the study participants.
The study is a continuation of FinHealth 2017 -study, which involved more than 7,000 Finns from around the country. The participants of FinHealth were invited to participate in P5.fi -study. The new research utilises information, samples, and measurements obtained in the FinHealth Study. Prospective clinical significance of selected genetic and metabolomic risk scores will be studied in 30.000 Finnish individuals. The study will analyze the genetic and metabolomic profile of the P5.fi participants and develop and test a protocol for returning them health related risk information. The impact of the intervention will by followed up by questionnaires and national health registers for five years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population of FinHealth 2017 -study represent the general population of Finland. All participants are over 18 years of age and have been selected randomly from the population registry. All FinHealth 2017 participants with DNA sample and permission for a re-contact were invited to P5.fi study.
Key inclusion criteria (1 listed)
- Only participants of FinHealth 2017 -study are eligible for the study
Key exclusion criteria (1 listed)
- Participants not part of FinHealth 2017 -study are not eligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary heart disease/Type 2 diabetes/Venous thromboembolism diagnosis
Time frame: Measure is assessed after a year from the start of the study.
Disease diagnosis observed from the national hospitalization and death registries.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
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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.
Markus Perola, MD, PhD principal investigator
National Institute of Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Type 2 Diabetes, run by Markus Perola at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Coronary heart disease/Type 2 diabetes/Venous thromboembolism diagnosis (time frame: Measure is assessed after a year from the start of the study.). 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 15 Jan 2021.