Akershus Cardiac Examination Study 1950 (ACE1950)

This study is currently recruiting participants.
Verified April 2013 by Vestre Viken Hospital Trust
Sponsor:
Information provided by (Responsible Party):
Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier:
NCT01555411
First received: March 13, 2012
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

ACE 1950 will be a large, observational, prospective, longitudinal, population-based cohort study. Subjects of either gender residing permanently in Akershus County and born in the year 1950 (approximately 6000 residents are of eligible age) will be invited to participate in the study.

The primary objective is to identify predictors for future AF development (clinical, biochemical, genetic, electrocardiographic and echocardiographic). The study will aim at identifying modifiable risk factors. Secondary objectives include assessment of prevalence and incidence of AF, as well as investigating clinical characteristics and comorbidity in the study population at baseline.


Condition
Atrial Fibrillation
Heart Failure
Stroke
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Akershus Cardiac Examination Study 1950 - a Cohort Study on Cardiovascular Disease in 60-65 Year-old Subjects

Resource links provided by NLM:


Further study details as provided by Vestre Viken Hospital Trust:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 6000
Study Start Date: January 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:

Background:

Atrial fibrillation (AF) is the most common heart rhythm disorder. The condition is associated with substantial mortality and morbidity from thromboembolism, heart failure and impaired cognitive function. AF plays a causal role in about 1/5 of ischemic stroke cases. An estimated 70,000 people in Norway have an AF diagnosis today. Most subjects with AF are older than 60 years. The absolute number of subjects with AF is increasing rapidly in the westernized world and is expected to triple between now and year 2050. Catheter ablation techniques for treatment of AF are improving; however, such treatment is expensive, not readily obtainable and long-term prognosis is uncertain. Secondary prevention of AF has proved difficult without anti-arrhythmic drugs; however "upstream" therapy for primary prevention of AF in subjects at risk of developing AF may be useful. Characterization of potentially modifiable risk factors for AF may therefore have substantial clinical importance.

Objectives:

The primary objective is to identify predictors for future AF development (clinical, biochemical, genetic, electrocardiographic and echocardiographic). The study will aim at identifying modifiable risk factors. Secondary objectives include assessment of prevalence and incidence of AF, as well as investigating clinical characteristics and comorbidity in the study population at baseline.

Methods:

ACE 1950 will be a large, observational, prospective, longitudinal, population-based cohort study. Subjects of either gender residing permanently in Akershus County and born in the year 1950 (approximately 6000 residents are of eligible age) will be invited to participate in the study. Participants will go through a thorough baseline examination, including a physical exam with height, weight and blood pressure measurements. Blood samples will be drawn for routine tests as well as more advanced biomarkers analysis. ECG and echocardiography will be performed. Self-completed questionnaires on medical history and quality of life will also be collected. The participants will then go through annual follow-up visits with new questionnaires and ECG, and will be encouraged to contact the study group if atrial fibrillation incidents occur.

Time schedule:

A comprehensive planning process, including preparation of protocol and applications, has taken place during 2011. The project is now awaiting ethical approval and is expected to start with study inclusion and baseline examinations early in 2012. This is expected to last for approximately 2 years. Baseline examinations are expected to be completed by 2013, and continuous follow-up of the participants will then begin. The first PhD degree is expected to be completed by the end of 2014. This large cohort study is expected to form the basis of a number of sub-studies and PhD degrees in years to come.

Scientific significance:

The most recent population-based studies on development of AF were launched up to 10-15 years ago, and did not, from the outset, study novel biomarkers or imaging techniques, nor were modern therapeutic modalities assessed. Consequently, a knowledge gap remains. We still do not know why prevalence figures differ so much between studies, or why men seemingly are more affected than women. A longitudinal study such as ours may answer more important questions, for instance, the relation of AF to other diseases such as dementia and diabetes. Moreover, it will be the most comprehensive atrial fibrillation population study ever performed in Norway.

  Eligibility

Ages Eligible for Study:   62 Years to 62 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
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: Trygve Berge, M.D. +47-67809117 trygve.berge@vestreviken.no

Locations
Norway
Akershus University Hospital Trust Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Helge Røsjø, MD, PhD       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         
Vestre Viken HF, Medical Research Department Recruiting
Rud, Akershus, Norway, 1309
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         
Sponsors and Collaborators
Vestre Viken Hospital Trust
Investigators
Study Director: Arnljot Tveit, MD, PhD Vestre Viken HF, Medical Research Department
Study Director: Helge Røsjø, MD, PhD Akershus University Hospital Trust
Principal Investigator: Trygve Berge, MD Vestre Viken HF, Medical Research Department
Principal Investigator: Mohammad Osman Pervez, MD Akershus University Hospital Trust, Dep. of Cardiology
  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: April 30, 2013
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
Cardiovascular imaging

Additional relevant MeSH terms:
Atrial Fibrillation
Cardiovascular Diseases
Heart Failure
Stroke
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014