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 : June 16, 2015
|Condition or disease|
|Atrial Fibrillation Heart Failure Mild Cognitive Impairment Cardiovascular Diseases Cerebrovascular Disorders|
Objectives: The overall aim of the Akershus Cardiac Examination (ACE) 1950 Study is to establish an extensive cardiovascular age cohort of elderly subjects for various longitudinal long-term follow-up studies of cardiovascular disease (CVD) and cerebrovascular disease (CeVD), focused towards atrial fibrillation, heart failure, stroke and cognitive function.
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. A comprehensive baseline examination, including advanced ultrasound imaging and biobanking, will be performed on 4,000+ men and women born in 1950.
Methods: Subjects of either gender residing permanently in Akershus County and born in the year 1950 (approximately 6000 residents of eligible age) will be invited to participate in the study. At the baseline visit of the ACE 1950 Study, all participants are subjected to; (1) structured clinical examination and interview, (2) advanced imaging (echocardiography, carotid and intracranial artery ultrasound), (3) blood sampling to establish a state-of-the-art biobank with genetic, serum and plasma samples (storage at -80°C), as well as immediate clinical chemistry analyses such as an extended hematogram, electrolytes, creatinine, liver enzymes, thyroid hormones, lipids, fasting blood glucose and glycated haemoglobin, (4) key clinical variables such as weight, height, hip- and waist circumference and blood pressure (measured in the sitting and supine position x 3, after 10 minutes rest), (5) 12-lead digital ECG in the supine position after 10 minutes rest (10-second recordings with 25 mm/s and 10 mm/mV), (6) cognitive function assessment by Ten-word test (CERAD), Montreal Cognitive Assessment (MOCA) and Trail-Making Test A + B. (7) pulmonary function test by standard spirometry, (8) a study-specific ACE 1950 questionnaire, as well as the validated questionnaires of Short-Form-36 (SF-36), the Hospital and Anxiety Scale (HADS) and Personality Type D Scale 14 (DS-14).
Time schedule: A comprehensive planning process, including preparation of protocol and applications, took place during 2011. After ethical approval, study inclusion and baseline examinations started September 2012. Inclusion is ongoing, and anticipated to last until 2015.
Study administration: The ACE 1950 Study is a collaborative project between two leading research groups at Baerum Hospital, Vestre Viken Hospital Trust and Akershus University Hospital. The study is directed by a steering committee. Each site has established a study team including one study director at each site, investigators (MDs, PhD students), study nurses and echo technicians. All study personnel have gone through joint training towards standard study procedures. Internal monitoring as well as tests of inter-observer variability between the sites are performed regularly, to ensure equal standards. An Events and Endpoints Committee will be set up.
Current status: As per July 2014, >1,900 subjects are recruited and have gone through baseline examinations. The response rate is anticipated at approximately 65-70% among the study population. Completion of the baseline examinations, with an expected approximately 4,000 subjects, is expected by the end of 2015.
Scientific significance: The ACE 1950 Study will generate new and relevant insight into novel approaches for identification of sub-clinical CVD/CeVD. Early identification of disease markers will ultimately allow for improved disease prevention.
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|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|
|Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||December 2050|
- Outcomes related to CVD and CV-associated conditions [ Time Frame: Maximum 35 years ]
- 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 ]
- 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
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
|Vestre Viken HT, Baerum Hospital, Department of Medical Research|
|Baerum, Akershus, Norway, 3004|
|Akershus University Hospital|
|Lørenskog, Akershus, Norway, 1478|
|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|