Akershus Cardiac Examination (ACE) 1950 Study (ACE1950)

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ClinicalTrials.gov Identifier: NCT01555411

Recruitment Status : Active, not recruiting

First Posted : March 15, 2012

Last Update Posted : May 7, 2018

Sponsor:

Collaborator:

University Hospital, Akershus

Information provided by (Responsible Party):

Vestre Viken Hospital Trust

Study Description

Brief 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 cerebrovascular disease.

Condition or disease
Atrial Fibrillation Heart Failure Mild Cognitive Impairment Cardiovascular Diseases Cerebrovascular Disorders

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. Follow-up and sub-studies are ongoing.

Current status: As per May 2018, follow-up and sub-studies are ongoing.

Study Design


Study Type :	Observational
Actual Enrollment :	3706 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Akershus Cardiac Examination 1950 Study - a Cohort Study on Cardio- and Cerebrovascular Disease in 62-65-year-old Subjects
Study Start Date :	September 2012
Actual Primary Completion Date :	May 2015
Estimated Study Completion Date :	December 2050

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Familial atrial fibrillation

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
No treatment

Outcome Measures

Primary Outcome Measures :

Outcomes related to CVD and CV-associated conditions [ Time Frame: Maximum 35 years ]

Secondary Outcome Measures :

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 ]

Other Outcome Measures:

Impact of left atrial size and function measurements by echocardiography on stroke risk in an 62-65-year-old cohort [ Time Frame: Within 35 years ]
Relation between cognitive function and sub-clinical CVD in a 62-65-year-old Norwegian population cohort [ Time Frame: Maximum 35 years ]

Biospecimen Retention: Samples With DNA

Blood samples, including for genetic testing, and urine.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	62 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Residents of Akershus County, Norway, born in 1950.

Criteria

Inclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555411

Locations


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

Sponsors and Collaborators

Vestre Viken Hospital Trust

University Hospital, Akershus

Investigators


Study Director:	Arnljot Tveit, MD, PhD	Vestre Viken Hospital Trust, Department of Medical Research
Study Director:	Helge Røsjø, MD, PhD	University Hospital, Akershus
Principal Investigator:	Trygve Berge - member of steering committee, MD	Vestre Viken Hospital Trust, Department of Medical Research
Principal Investigator:	Pål Smith - member of steering committee, MD, PhD	University Hospital, Akershus
Principal Investigator:	Kjetil Steine - member of steering committee, MD, PhD	University Hospital, Akershus
Principal Investigator:	Torbjørn Omland - member of steering committee, MD, PhD	University Hospital, Akershus
Principal Investigator:	Magnus N Lyngbakken - member of steering committee, MD	University Hospital, Akershus

More Information

Additional Information:

Study website This link exits the ClinicalTrials.gov site

Publications of Results:

Ihle-Hansen H, Vigen T, Berge T, Einvik G, Aarsland D, Rønning OM, Thommessen B, Røsjø 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.

Berge T, Brynildsen J, Larssen HKN, Onarheim S, Jenssen GR, Ihle-Hansen H, Christophersen IE, Myrstad M, Røsjø 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.

Other Publications:

Berge T, Vigen T, Pervez MO, Ihle-Hansen H, Lyngbakken MN, Omland T, Smith P, Steine K, Røsjø 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Røsjø 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.

Ihle-Hansen H, Vigen T, Ihle-Hansen H, Rønning OM, Berge T, Thommessen B, Lyngbakken MN, Orstad EB, Enger S, Nygård S, Røsjø 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). pii: e008562. doi: 10.1161/JAHA.118.008562.


Responsible Party:	Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier:	NCT01555411 History of Changes
Other Study ID Numbers:	2011/1475 C AFIA (initial study name) ( Other Identifier: Vestre Viken Hospital Trust and Akershus University Hospital )
First Posted:	March 15, 2012 Key Record Dates
Last Update Posted:	May 7, 2018
Last Verified:	May 2018

Keywords provided by Vestre Viken Hospital Trust:


Cardiovascular epidemiology Prospective, observational cohort study Biomarkers Cardio- and cerebrovascular imaging

Additional relevant MeSH terms:


Heart Failure Atrial Fibrillation Cardiovascular Diseases Cognitive Dysfunction Cerebrovascular Disorders Heart Diseases Arrhythmias, Cardiac Pathologic Processes	Cognition Disorders Neurocognitive Disorders Mental Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases

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