Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Professor Mårten Rosenqvist, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01593553
First received: May 4, 2012
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Stroke
Other: ECG screening for atrial fibrillation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Reduced incidence of stroke among 75 year old subjects. [ Time Frame: Five years. Interim analysis after 3 years. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cost effectivity [ Time Frame: Five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 6500
Study Start Date: March 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ECG screening Other: ECG screening for atrial fibrillation
ECG screening for atrial fibrillation with intermittent ECG recording for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.
No Intervention: Control group

  Eligibility

Ages Eligible for Study:   75 Years to 76 Years
Genders Eligible for Study:   Both
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
  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: NCT01593553

Contacts
Contact: Anna Hollander, RN LicMedSci +46-8-51778214 anna.hollander@karolinska.se

Locations
Sweden
Karolinska Trial Alliance, KTA Prim Recruiting
Stockholm, Sweden, 11361
Contact: Mårten Rosenqvist, Professor       marten.rosenqvist@sodersjukhuset.se   
Contact: Anna Hollander, RN       anna.hollander@karolinska.se   
Sponsors and Collaborators
Karolinska University Hospital
  More Information

No publications provided

Responsible Party: Professor Mårten Rosenqvist, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01593553     History of Changes
Other Study ID Numbers: Strokestop
Study First Received: May 4, 2012
Last Updated: May 7, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Screening
Stroke prevention
Cost effectiveness

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

ClinicalTrials.gov processed this record on August 26, 2014