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Akershus Cardiac Examination (ACE) 1950 Study (ACE1950)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01555411
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : October 24, 2019
Sponsor:
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Vestre Viken Hospital Trust

Tracking Information
First Submitted Date March 13, 2012
First Posted Date March 15, 2012
Last Update Posted Date October 24, 2019
Actual Study Start Date September 2012
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2014)
Outcomes related to CVD and CV-associated conditions [ Time Frame: Maximum 35 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: August 13, 2014)
  • 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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 13, 2014)
  • 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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Akershus Cardiac Examination (ACE) 1950 Study
Official Title Akershus Cardiac Examination 1950 Study - a Cohort Study on Cardio- and Cerebrovascular Disease in 62-65-year-old Subjects
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples, including for genetic testing, and urine.
Sampling Method Non-Probability Sample
Study Population Residents of Akershus County, Norway, born in 1950.
Condition
  • Atrial Fibrillation
  • Heart Failure
  • Mild Cognitive Impairment
  • Cardiovascular Diseases
  • Cerebrovascular Disorders
Intervention Not Provided
Study Groups/Cohorts No treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 1, 2018)
3706
Original Estimated Enrollment
 (submitted: March 13, 2012)
6000
Estimated Study Completion Date January 2050
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 62 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01555411
Other Study ID Numbers 2011/1475 C
AFIA (initial study name) ( Other Identifier: Vestre Viken Hospital Trust and Akershus University Hospital )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vestre Viken Hospital Trust
Study Sponsor Vestre Viken Hospital Trust
Collaborators 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
PRS Account Vestre Viken Hospital Trust
Verification Date October 2019