Akershus Cardiac Examination (ACE) 1950 Study (ACE1950)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vestre Viken Hospital Trust
Sponsor:
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier:
NCT01555411
First received: March 13, 2012
Last updated: June 25, 2014
Last verified: June 2014

March 13, 2012
June 25, 2014
September 2012
December 2015   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01555411 on ClinicalTrials.gov Archive Site
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Akershus Cardiac Examination (ACE) 1950 Study
Akershus Cardiac Examination 1950 Study - a Cohort Study on Cardio- and Cerebrovascular Disease in 62-65-year-old Subjects

Akershus Cardiac Examination (ACE) 1950 Study will be 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.

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. The first PhD degree is expected to be completed by 2016. This large cohort study is expected to form the basis of a number of sub-studies and PhD degrees in the years to come.

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. At the moment 4 PhD projects are involved in the project, and more projects will be planned in the future. 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood and serum specimens, for later not yet fully defined analysis.

Non-Probability Sample

Residents of Akershus County, Norway, born in 1950.

  • Atrial Fibrillation
  • Heart Failure
  • Stroke
  • Cardiovascular Diseases
Not Provided
No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
December 2050
December 2015   (final data collection date for primary outcome measure)

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
Both
62 Years to 65 Years
Yes
Contact: Arnljot Tveit, M.D., PhD +47-67809924 arnljot.tveit@vestreviken.no
Contact: Helge Røsjø, M.D., PhD helge.rosjo@medisin.uio.no
Norway
 
NCT01555411
2011/1475 C, AFIA (initial study name)
Yes
Vestre Viken Hospital Trust
Vestre Viken Hospital Trust
University Hospital, Akershus
Study Director: Arnljot Tveit, MD, PhD Vestre Viken Health Trust, Department of Medical Research
Study Director: Helge Røsjø, MD, PhD Akershus University Hospital Trust
Principal Investigator: Trygve Berge, MD Vestre Viken Health Trust, Department of Medical Research
Principal Investigator: Mohammad Osman Pervez, MD Akershus University Hospital Trust
Principal Investigator: Håkon Ihle-Hansen, MD Vestre Viken Health Trust, Department of Medical Research
Principal Investigator: Thea Vigen, MD Akershus University Hospital Trust
Vestre Viken Hospital Trust
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP