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Akershus Cardiac Examination (ACE) 1950 Study (ACE1950)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 13, 2014
Last verified: August 2014
  Purpose

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.


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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Vestre Viken Hospital Trust:

Primary Outcome Measures:
  • Outcomes related to CVD and CV-associated conditions [ Time Frame: Maximum 35 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Specific CV endpoints; e.g. acute myocardial infarction, heart failure, atrial fibrillation, etc. [ Time Frame: Maximum 35 years ] [ Designated as safety issue: No ]
  • Specific CV-associated conditions, including renal, cerebrovascular, pulmonary, etc. [ Time Frame: Maximum 35 years ] [ Designated as safety issue: No ]
  • Specific clinical phenotypes; e.g. myocardial and arterial structure and function, lung function, etc. [ Time Frame: Maximum 35 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Relation between cognitive function and sub-clinical CVD in a 62-65-year-old Norwegian population cohort [ Time Frame: Maximum 35 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples, including for genetic testing, and urine.


Estimated Enrollment: 4000
Study Start Date: September 2012
Estimated Study Completion Date: December 2050
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   62 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555411

Contacts
Contact: Arnljot Tveit, M.D., PhD +47-67809924 arnljot.tveit@vestreviken.no
Contact: Helge Røsjø, M.D., PhD +47-91502900 helge.rosjo@medisin.uio.no

Locations
Norway
Vestre Viken HT, Baerum Hospital, Department of Medical Research Recruiting
Baerum, Akershus, Norway, 3004
Contact: Arnljot Tveit, MD, PhD    +4767809924    arnljot.tveit@vestreviken.no   
Contact: Trygve Berge, MD    +4767809117    trygve.berge@vestreviken.no   
Sub-Investigator: Trygve Berge, MD         
Sub-Investigator: Håkon Ihle-Hansen, MD         
Principal Investigator: Arnljot Tveit, MD, PhD         
Akershus University Hospital Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Helge Røsjø, MD, PhD    +4791502900    helge.rosjo@medisin.uio.no   
Contact: Mohammad Osman Pervez, MD       mohammad.osman.pervez@ahus.no   
Sub-Investigator: Mohammad Osman Pervez, MD         
Sub-Investigator: Thea Vigen, MD         
Principal Investigator: Helge Røsjø, MD, PhD         
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
  More Information

No publications provided

Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT01555411     History of Changes
Other Study ID Numbers: 2011/1475 C, AFIA (initial study name)
Study First Received: March 13, 2012
Last Updated: August 13, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Vestre Viken Hospital Trust:
Cardiovascular epidemiology
Prospective, observational cohort study
Biomarkers
Cardio- and cerebrovascular imaging

Additional relevant MeSH terms:
Atrial Fibrillation
Cardiovascular Diseases
Cerebrovascular Disorders
Cognition Disorders
Heart Failure
Mild Cognitive Impairment
Arrhythmias, Cardiac
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Heart Diseases
Mental Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014