Atrial FibrillationACE1950NCT01555411

Akershus Cardiac Examination (ACE) 1950 Study

An observational study of Atrial Fibrillation and Heart Failure, run by Vestre Viken Hospital Trust at 2 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Akershus Cardiac Examination (ACE) 1950 Study is a large, observational, prospective, longitudinal, population-based cohort study. The overall aim is to establish an extensive cardio- and cerebrovascular age cohort of elderly subjects for various longitudinal long-term follow-up studies of cardiovascular and… Read more about this study

Who is it for?: Ages 62 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Atrial Fibrillation, Heart Failure, Mild Cognitive Impairment
How many people: 3,706 participants
Where: 2 sitesNorway
Study dates: Sep 2012to 31 Dec 2050
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 62 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Residents of Akershus County, Norway, born in 1950.

Who may be able to join

Resident in Akershus County (as per October 2011, prior to study invitation)
Born in the year of 1950
Ability to consent to participation

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Norway2 sites

Akershus University Hospital
Lørenskog, Akershus, 1478
Vestre Viken HT, Baerum Hospital, Department of Medical Research
Sandvika, Akershus, 3004

Other trials in Norway

About this study

Official title: Akershus Cardiac Examination 1950 Study - a Cohort Study on Cardio- and Cerebrovascular Disease in 62-65-year-old Subjects

Read the detailed description

Design: The Akershus Cardiac Examination (ACE) 1950 Study is a population-based, prospective, cerebro- and cardiovascular age-cohort study of all men and women born in 1950 in Akershus County, Norway.

Time schedule: Study inclusion and baseline examinations took place in the period September 2012 - May 2015.

Current status: 10-year follow-up examinations of all participants are undertaken in 2023-2025, and sub-studies are ongoing.

Conditions: Atrial Fibrillation, Heart Failure, Mild Cognitive Impairment, Cardiovascular Diseases, Cerebrovascular Disorders
Keywords: Cardiovascular epidemiology, Prospective, observational cohort study, Biomarkers, Cardio- and cerebrovascular imaging
Medical subject headings: Atrial Fibrillation, Heart Failure, Cognitive Dysfunction, Cardiovascular Diseases, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01555411
Study group	Role	What they receive
No treatment		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Outcomes related to CVD and CV-associated conditions
Measured: Maximum 35 years

Secondary outcomes (3)

Specific CV endpoints; e.g. acute myocardial infarction, heart failure, atrial fibrillation, etc.
Measured: Maximum 35 years
Specific CV-associated conditions, including renal, cerebrovascular, pulmonary, etc.
Measured: Maximum 35 years
Specific clinical phenotypes; e.g. myocardial and arterial structure and function, lung function, etc.
Measured: Maximum 35 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201231 Dec 2050

First posted15 Mar 2012 (estimated)
Study startSep 2012
Primary completion31 Dec 2050 (estimated)
Study completion31 Dec 2050 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies 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: 3,706 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01555411
Sponsor's protocol ID: 2011/1475 C
Other IDs: AFIA (initial study name)
Acronym: ACE1950
Status last verified: May 2024
First submitted: 13 Mar 2012
Last updated: 8 May 2024
Results posted: No
Data monitoring committee: Yes

Publications

Berge T, Vigen T, Pervez MO, Ihle-Hansen H, Lyngbakken MN, Omland T, Smith P, Steine K, Rosjo H, Tveit A; ACE 1950 Study Group. Heart and Brain Interactions--the Akershus Cardiac Examination (ACE) 1950 Study Design. Scand Cardiovasc J. 2015;49(6):308-15. doi: 10.3109/14017431.2015.1086813. Epub 2015 Sep 12.
PubMed 26364744
Ihle-Hansen H, Vigen T, Berge T, Einvik G, Aarsland D, Ronning OM, Thommessen B, Rosjo H, Tveit A, Ihle-Hansen H. Montreal Cognitive Assessment in a 63- to 65-year-old Norwegian Cohort from the General Population: Data from the Akershus Cardiac Examination 1950 Study. Dement Geriatr Cogn Dis Extra. 2017 Sep 28;7(3):318-327. doi: 10.1159/000480496. eCollection 2017 Sep-Dec.
PubMed 29118784
Berge T, Brynildsen J, Larssen HKN, Onarheim S, Jenssen GR, Ihle-Hansen H, Christophersen IE, Myrstad M, Rosjo H, Smith P, Tveit A. Systematic screening for atrial fibrillation in a 65-year-old population with risk factors for stroke: data from the Akershus Cardiac Examination 1950 study. Europace. 2018 Nov 1;20(FI_3):f299-f305. doi: 10.1093/europace/eux293.
PubMed 29095966
Berge T, Lyngbakken MN, Ihle-Hansen H, Brynildsen J, Pervez MO, Aagaard EN, Vigen T, Kvisvik B, Christophersen IE, Steine K, Omland T, Smith P, Rosjo H, Tveit A. Prevalence of atrial fibrillation and cardiovascular risk factors in a 63-65 years old general population cohort: the Akershus Cardiac Examination (ACE) 1950 Study. BMJ Open. 2018 Aug 1;8(7):e021704. doi: 10.1136/bmjopen-2018-021704.
PubMed 30068617
Ihle-Hansen H, Vigen T, Ihle-Hansen H, Ronning OM, Berge T, Thommessen B, Lyngbakken MN, Orstad EB, Enger S, Nygard S, Rosjo H, Tveit A. Prevalence of Carotid Plaque in a 63- to 65-Year-Old Norwegian Cohort From the General Population: The ACE (Akershus Cardiac Examination) 1950 Study. J Am Heart Assoc. 2018 May 8;7(10):e008562. doi: 10.1161/JAHA.118.008562.
PubMed 29739796
Chandra A, Rosjo H, Eide IA, Vigen T, Ihle-Hansen H, Orstad EB, Ronning OM, Lyngbakken MN, Berge T, Schmidt EB, Omland T, Tveit A, Svensson M. Plasma marine n-3 polyunsaturated fatty acids and cardiovascular risk factors: data from the ACE 1950 study. Eur J Nutr. 2020 Jun;59(4):1505-1515. doi: 10.1007/s00394-019-02007-3. Epub 2019 May 23.
PubMed 31123865
Vigen T, Ihle-Hansen H, Lyngbakken MN, Berge T, Thommessen B, Ihle-Hansen H, Orstad EB, Enger S, Ariansen I, Rosjo H, Tveit A, Ronning OM. Blood pressure at age 40 predicts carotid atherosclerosis two decades later: data from the Akershus Cardiac Examination 1950 Study. J Hypertens. 2019 Oct;37(10):1982-1990. doi: 10.1097/HJH.0000000000002131.
PubMed 31116158
Ihle-Hansen H, Vigen T, Berge T, Hagberg G, Engedal K, Ronning OM, Thommessen B, Lyngbakken MN, Nygard S, Rosjo H, Tveit A, Ihle-Hansen H. Carotid Atherosclerosis and Cognitive Function in a General Population Aged 63-65 Years: Data from the Akershus Cardiac Examination (ACE) 1950 Study. J Alzheimers Dis. 2019;70(4):1041-1049. doi: 10.3233/JAD-190327.
PubMed 31306128
Aagaard EN, Kvisvik B, Pervez MO, Lyngbakken MN, Berge T, Enger S, Orstad EB, Smith P, Omland T, Tveit A, Rosjo H, Steine K. Left ventricular mechanical dispersion in a general population: Data from the Akershus Cardiac Examination 1950 study. Eur Heart J Cardiovasc Imaging. 2020 Feb 1;21(2):183-190. doi: 10.1093/ehjci/jez210.
PubMed 31504360
Vigen T, Ihle-Hansen H, Lyngbakken MN, Berge T, Thommessen B, Ihle-Hansen H, Orstad EB, Enger S, Rosjo H, Tveit A, Ronning OM. Carotid Atherosclerosis is Associated with Middle Cerebral Artery Pulsatility Index. J Neuroimaging. 2020 Mar;30(2):233-239. doi: 10.1111/jon.12684. Epub 2019 Dec 30.
PubMed 31889363
Ronningen PS, Berge T, Solberg MG, Enger S, Nygard S, Pervez MO, Orstad EB, Kvisvik B, Aagaard EN, Rosjo H, Tveit A, Steine K. Sex differences and higher upper normal limits for left atrial end-systolic volume in individuals in their mid-60s: data from the ACE 1950 Study. Eur Heart J Cardiovasc Imaging. 2020 May 1;21(5):501-507. doi: 10.1093/ehjci/jeaa004.
PubMed 32031593
Lyngbakken MN, Aagaard EN, Kvisvik B, Berge T, Pervez MO, Brynildsen J, Tveit A, Steine K, Rosjo H, Omland T. Cardiac Troponin I and T Are Associated with Left Ventricular Function and Structure: Data from the Akershus Cardiac Examination 1950 Study. Clin Chem. 2020 Apr 1;66(4):567-578. doi: 10.1093/clinchem/hvaa023.
PubMed 32227098
Chandra A, Rosjo H, Svensson M, Vigen T, Ihle-Hansen H, Orstad EB, Ronning OM, Lyngbakken MN, Nygard S, Berge T, Schmidt EB, Omland T, Tveit A, Eide IA. Plasma linoleic acid levels and cardiovascular risk factors: results from the Norwegian ACE 1950 Study. Eur J Clin Nutr. 2020 Dec;74(12):1707-1717. doi: 10.1038/s41430-020-0641-4. Epub 2020 Apr 27.
PubMed 32341488
Chandra A, Lyngbakken MN, Eide IA, Rosjo H, Vigen T, Ihle-Hansen H, Orstad EB, Ronning OM, Berge T, Schmidt EB, Tveit A, Omland T, Svensson M. Plasma Trans Fatty Acid Levels, Cardiovascular Risk Factors and Lifestyle: Results from the Akershus Cardiac Examination 1950 Study. Nutrients. 2020 May 14;12(5):1419. doi: 10.3390/nu12051419.
PubMed 32423040
Lyngbakken MN, Kvisvik B, Aagaard EN, Berge T, Pervez MO, Brynildsen J, Tveit A, Steine K, Rosjo H, Omland T. B-Type Natriuretic Peptide Is Associated with Indices of Left Ventricular Dysfunction in Healthy Subjects from the General Population: The Akershus Cardiac Examination 1950 Study. Clin Chem. 2021 Jan 8;67(1):204-215. doi: 10.1093/clinchem/hvaa257.
PubMed 33279958

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Akershus Cardiac Examination 1950 Study - a Cohort Study on Cardio- and Cerebrovascular Disease in 62-65-year-old Subjects
ClinicalTrials.gov ID: NCT01555411
Acronym / sponsor ID: ACE1950 / 2011/1475 C
Conditions: Atrial Fibrillation, Heart Failure, Mild Cognitive Impairment, Cardiovascular Diseases, Cerebrovascular Disorders
Keywords: Cardiovascular epidemiology, Prospective, observational cohort study, Biomarkers, Cardio- and cerebrovascular imaging
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 3,706 participants (estimated)
Lead sponsor: Vestre Viken Hospital TrustUniversity, hospital or other
Collaborators: University Hospital, Akershus
Study start: Sep 2012 (actual)
Primary completion: 31 Dec 2050 (estimated)
Study completion: 31 Dec 2050 (estimated)
First posted: 15 Mar 2012 (estimated)
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.

Detailed description

Time schedule: Study inclusion and baseline examinations took place in the period September 2012 - May 2015.

Current status: 10-year follow-up examinations of all participants are undertaken in 2023-2025, and sub-studies are ongoing.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
No treatment	–	–

Who may qualify

Ages: 62 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Residents of Akershus County, Norway, born in 1950.

Key inclusion criteria (3 listed)

Resident in Akershus County (as per October 2011, prior to study invitation)
Born in the year of 1950
Ability to consent to participation

Key exclusion criteria (0 listed)

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

Outcomes related to CVD and CV-associated conditions
Time frame: Maximum 35 years

3 secondary outcomes

Specific CV endpoints; e.g. acute myocardial infarction, heart failure, atrial fibrillation, etc.
Time frame: Maximum 35 years
Specific CV-associated conditions, including renal, cerebrovascular, pulmonary, etc.
Time frame: Maximum 35 years
Specific clinical phenotypes; e.g. myocardial and arterial structure and function, lung function, etc.
Time frame: Maximum 35 years

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 8 May 2024.
Background: PubMed 26364744Berge T, Vigen T, Pervez MO, Ihle-Hansen H, Lyngbakken MN, Omland T, Smith P, Steine K, Rosjo H, Tveit A; ACE 1950 Study Group. Heart and Brain Interactions--the Akershus Cardiac Examination (ACE) 1950 Study Design. Scand Cardiovasc J. 2015;49(6):308-15. doi: 10.3109/14017431.2015.1086813. Epub 2015 Sep 12.
Results publication: PubMed 29118784Ihle-Hansen H, Vigen T, Berge T, Einvik G, Aarsland D, Ronning OM, Thommessen B, Rosjo H, Tveit A, Ihle-Hansen H. Montreal Cognitive Assessment in a 63- to 65-year-old Norwegian Cohort from the General Population: Data from the Akershus Cardiac Examination 1950 Study. Dement Geriatr Cogn Dis Extra. 2017 Sep 28;7(3):318-327. doi: 10.1159/000480496. eCollection 2017 Sep-Dec.
Results publication: PubMed 29095966Berge T, Brynildsen J, Larssen HKN, Onarheim S, Jenssen GR, Ihle-Hansen H, Christophersen IE, Myrstad M, Rosjo H, Smith P, Tveit A. Systematic screening for atrial fibrillation in a 65-year-old population with risk factors for stroke: data from the Akershus Cardiac Examination 1950 study. Europace. 2018 Nov 1;20(FI_3):f299-f305. doi: 10.1093/europace/eux293.
Results publication: PubMed 30068617Berge T, Lyngbakken MN, Ihle-Hansen H, Brynildsen J, Pervez MO, Aagaard EN, Vigen T, Kvisvik B, Christophersen IE, Steine K, Omland T, Smith P, Rosjo H, Tveit A. Prevalence of atrial fibrillation and cardiovascular risk factors in a 63-65 years old general population cohort: the Akershus Cardiac Examination (ACE) 1950 Study. BMJ Open. 2018 Aug 1;8(7):e021704. doi: 10.1136/bmjopen-2018-021704.
Results publication: PubMed 29739796Ihle-Hansen H, Vigen T, Ihle-Hansen H, Ronning OM, Berge T, Thommessen B, Lyngbakken MN, Orstad EB, Enger S, Nygard S, Rosjo H, Tveit A. Prevalence of Carotid Plaque in a 63- to 65-Year-Old Norwegian Cohort From the General Population: The ACE (Akershus Cardiac Examination) 1950 Study. J Am Heart Assoc. 2018 May 8;7(10):e008562. doi: 10.1161/JAHA.118.008562.
Results publication: PubMed 31123865Chandra A, Rosjo H, Eide IA, Vigen T, Ihle-Hansen H, Orstad EB, Ronning OM, Lyngbakken MN, Berge T, Schmidt EB, Omland T, Tveit A, Svensson M. Plasma marine n-3 polyunsaturated fatty acids and cardiovascular risk factors: data from the ACE 1950 study. Eur J Nutr. 2020 Jun;59(4):1505-1515. doi: 10.1007/s00394-019-02007-3. Epub 2019 May 23.
Results publication: PubMed 31116158Vigen T, Ihle-Hansen H, Lyngbakken MN, Berge T, Thommessen B, Ihle-Hansen H, Orstad EB, Enger S, Ariansen I, Rosjo H, Tveit A, Ronning OM. Blood pressure at age 40 predicts carotid atherosclerosis two decades later: data from the Akershus Cardiac Examination 1950 Study. J Hypertens. 2019 Oct;37(10):1982-1990. doi: 10.1097/HJH.0000000000002131.
Results publication: PubMed 31306128Ihle-Hansen H, Vigen T, Berge T, Hagberg G, Engedal K, Ronning OM, Thommessen B, Lyngbakken MN, Nygard S, Rosjo H, Tveit A, Ihle-Hansen H. Carotid Atherosclerosis and Cognitive Function in a General Population Aged 63-65 Years: Data from the Akershus Cardiac Examination (ACE) 1950 Study. J Alzheimers Dis. 2019;70(4):1041-1049. doi: 10.3233/JAD-190327.
Results publication: PubMed 31504360Aagaard EN, Kvisvik B, Pervez MO, Lyngbakken MN, Berge T, Enger S, Orstad EB, Smith P, Omland T, Tveit A, Rosjo H, Steine K. Left ventricular mechanical dispersion in a general population: Data from the Akershus Cardiac Examination 1950 study. Eur Heart J Cardiovasc Imaging. 2020 Feb 1;21(2):183-190. doi: 10.1093/ehjci/jez210.
Results publication: PubMed 31889363Vigen T, Ihle-Hansen H, Lyngbakken MN, Berge T, Thommessen B, Ihle-Hansen H, Orstad EB, Enger S, Rosjo H, Tveit A, Ronning OM. Carotid Atherosclerosis is Associated with Middle Cerebral Artery Pulsatility Index. J Neuroimaging. 2020 Mar;30(2):233-239. doi: 10.1111/jon.12684. Epub 2019 Dec 30.
Results publication: PubMed 32031593Ronningen PS, Berge T, Solberg MG, Enger S, Nygard S, Pervez MO, Orstad EB, Kvisvik B, Aagaard EN, Rosjo H, Tveit A, Steine K. Sex differences and higher upper normal limits for left atrial end-systolic volume in individuals in their mid-60s: data from the ACE 1950 Study. Eur Heart J Cardiovasc Imaging. 2020 May 1;21(5):501-507. doi: 10.1093/ehjci/jeaa004.
Results publication: PubMed 32227098Lyngbakken MN, Aagaard EN, Kvisvik B, Berge T, Pervez MO, Brynildsen J, Tveit A, Steine K, Rosjo H, Omland T. Cardiac Troponin I and T Are Associated with Left Ventricular Function and Structure: Data from the Akershus Cardiac Examination 1950 Study. Clin Chem. 2020 Apr 1;66(4):567-578. doi: 10.1093/clinchem/hvaa023.
Study websiteLink provided by the sponsor.

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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.

Arnljot Tveit, MD, PhD study director

Vestre Viken Hospital Trust, Department of Medical Research

Helge Røsjø, MD, PhD study director

University Hospital, Akershus

Trygve Berge - member of steering committee, MD principal investigator

Vestre Viken Hospital Trust, Department of Medical Research

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Heart Failure, run by Vestre Viken Hospital Trust at 2 sites in Norway.

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 0 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. 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?

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?

Outcomes related to CVD and CV-associated conditions (time frame: Maximum 35 years). 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 NCT01555411, which also lists 30 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 8 May 2024.