Clinical trial NCT01593553: Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden
Official title: Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Keywords: Screening
Stroke prevention
Cost effectiveness
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 7173
Sex: ALL
Minimum age (years): 75
Maximum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether screening for atrial fibrillation by intermittent ECG recording and initiation of anticoagulation treatment among high risk individuals is cost-effective and can lower the incidence of stroke.


Eligibility criteria: Inclusion Criteria:

* Men and women 75-76 years of age living in the region of Stockholm or Halland

Exclusion Criteria:

* Not fulfilling the inclusion criteria

Primary outcomes:
measure: Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause
timeFrame: Five years. Interim analysis after 3 years.
Secondary outcomes:
measure: Ischaemic stroke
timeFrame: Five years. Interim analysis after 3 years.
measure: Ischaemic stroke and systemic thromboembolism
timeFrame: Five years. Interim analysis after 3 years.
measure: Ischaemic stroke and systemic thromboembolism
timeFrame: Five years. Interim analysis after 3 years.
measure: Dementia
timeFrame: Five years. Interim analysis after 3 years.
measure: All cause mortality
timeFrame: Five years. Interim analysis after 3 years.
measure: Cardiovascular mortality
timeFrame: Five years. Interim analysis after 3 years.
measure: Hospitalization due to cardiovascular disease
timeFrame: Five years. Interim analysis after 3 years.
measure: Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization, hospitalization due to cardiovascular disease or death from any cause
timeFrame: Five years. Interim analysis after 3 years.
measure: Cost effectivity
timeFrame: Five years
measure: Initiation and compliance to oral anticoagulation therapy
timeFrame: Five years
measure: Detection of atrial fibrillation
timeFrame: Five years
measure: Pulmonary embolism and deep vein thrombosis
timeFrame: Five years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, KTA Prim
Study officials:
References:
citation: Svennberg E, Friberg L, Frykman V, Al-Khalili F, Engdahl J, Rosenqvist M. Clinical outcomes in systematic screening for atrial fibrillation (STROKESTOP): a multicentre, parallel group, unmasked, randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1498-1506. doi: 10.1016/S0140-6736(21)01637-8. Epub 2021 Aug 29.
citation: Hygrell T, Stridh M, Friberg L, Svennberg E. Prognostic Implications of Supraventricular Arrhythmias. Am J Cardiol. 2021 Jul 15;151:57-63. doi: 10.1016/j.amjcard.2021.04.020.
citation: Svennberg E, Henriksson P, Engdahl J, Hijazi Z, Al-Khalili F, Friberg L, Frykman V. N-terminal pro B-type natriuretic peptide in systematic screening for atrial fibrillation. Heart. 2017 Aug;103(16):1271-1277. doi: 10.1136/heartjnl-2016-310236. Epub 2017 Mar 2.
citation: Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.