Akershus Cardiac Examination (ACE) 1950 Study "ACE1950"

Active, not recruiting

Phase N/A Results N/A

Update History

17 Jun '15
A location was updated in Baerum.
New
The overall status was removed for Vestre Viken HT, Baerum Hospital, Department of Medical Research.
A location was updated in Lørenskog.
New
The overall status was removed for Akershus University Hospital.
16 Aug '14
The description was updated.
New
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.
Old
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.
27 Jun '14
Trial name was updated.
New
Akershus Cardiac Examination (ACE) 1950 Study
The Summary of Purpose was updated.
New
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.
Old
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.
The description was updated.
New
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.
Old
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.