The ACE 1950 Study is a prospective, population-based, cohort study of the cardio- and cerebrovascular health of all men and women born in 1950 in Akershus County, Norway.
Study population and demography
The study is enrolling men and women born in 1950, who were permanent residents of Akershus County in November 2011, according to the Norwegian Population Registry. There were 5,827 eligible subjects in the study population. Akershus County is an area of 4,918 km2, surrounding Oslo, the capital of Norway. The total population in the area is 576,000 (January 2014), which makes it the second largest county by population after Oslo.
Study sites
Two general hospitals provide health care services to the people of the county: Bærum Hospital (the western region) and Akershus University Hospital (the northern and eastern regions). These two are the collaborating partners and study sites of the ACE 1950 Study. Both sites have established research facilities including experienced staff and biobank facilities.
Baseline examination
At the baseline visit, performed in 2012-2015, all participants were subjected to an interview and a clinical examination including cognitive tests, blood sampling, spirometry, and advanced imaging (Baseline data variables in the ACE 1950 Study).
Follow-up and endpoints
All Norwegian citizens have an 11-digit personal identification number, which can be used to collect event data from national health registries, such as the Norwegian Patient Registry, the CVD Registry, and the Cause of Death Registry. Data from these Sources will be collected from 2016 onwards. Other relevant registries, such as the Norwegian Prescription Database, may also be used. Hospital records will be used as a secondary source, for more detailed information and verification when necessary.
All major cardio- and cerebrovascular events (according to ICD-10 categories), collected from any of the above-mentioned data sources, will be registered by physician researchers, and validated by the Endpoint Committee. Furthermore, we plan to perform linkage of our data to previous cohorts in Norway with partly overlapping participation, enabling a rich collection of prospective data with clinical relevance over several decades.
Ethics
The study protocol has been approved by the Regional Committees for Medical and Health Research Ethics in Norway (September 7th, 2011. Ref. number 2011/1475), and renewed approval is being applied for in case of amendments to the study protocol. The study has also been evaluated by the Norwegian Directorate of Health with regard to genetic analyses. The study consent form permits relevant data to be retrieved from the hospital Medical records, including the general practitioners’ records as well as national morbidity and mortality registries. The study is registered at clinicaltrials.gov with registration number: NCT01555411.
Study organization
Project name: Akershus Cardiac Examination (ACE) 1950 Study.
Project leader: Arnljot Tveit, MD, PhD, Head of Department of Medical Research, Bærum Hospital, Vestre Viken Hospital Trust and Professor of Medicine, Department of Cardiology, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Co-Project leader: Helge Røsjø, MD, PhD, Physician, Division of Medicine, Akershus University Hospital and Researcher, Institute of Clinical Medicine, University of Oslo, Norway. Currently Cardiology fellow and post-doctoral fellow, University Hospital Uppsala and Uppsala Clinical Research Center, Uppsala, Sweden.
Project Coordinator: Trygve Berge, MD, PhD, Researcher, Department of Medical Research, Bærum Hospital, Vestre Viken Hospital Trust.
Steering Committee: Arnljot Tveit (Chairman), Helge Røsjø, Trygve Berge, Pål Smith MD, PhD, Professor emer., Kjetil Steine MD, PhD, Associate Professor (Akershus University Hospital), Torbjørn Omland MD, PhD, Professor (Akershus University Hospital), Magnus Nakrem Lyngbakken MD, PhD (Akershus University Hospital).
User Panel: 4 study participants (one woman and one man from each study site); 2 general practitioners (one from each study site’s catchment area); and 2 representatives from patient organizations (one from the Norwegian Health Association and one from the National Association for Heart and Lung Disease (LHL).
Institutions: The ACE 1950 Study is a collaboration project between the Department of Medical Research, Bærum Hospital, Vestre Viken Hospital Trust and the Research Department, Medical Division, Akershus University Hospital.
Funding: The project is funded by Vestre Viken Hospital trust og Akershus University Hospital. Additional funding has been provided by South-Eastern Norway Regional Health Authority, Norwegian Health Assocociation and University of Oslo.
Approved by REC (Regional Committees for Medical and Health Research Ethics ): Reference 2011/1475.
ClinicalTrials.gov: NCT01555411
Additional information
If you need additional information, please contact the Project leader here.
ACE 1950 