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Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring

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ClinicalTrials.gov Identifier: NCT01855035
Recruitment Status : Unknown
Verified February 2017 by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH.
Recruitment status was:  Active, not recruiting
First Posted : May 16, 2013
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Tracking Information
First Submitted Date  ICMJE May 7, 2013
First Posted Date  ICMJE May 16, 2013
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
number of atrial fibrillation/flutter [ Time Frame: 30 month after study start ]
The primary endpoint is the detection of newly diagnosed atrial fibrillation/flutter within 6 months and before occurrence of recurrent stroke or systemic embolism in the treatment group compared to control group.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01855035 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
  • number of atrial fibrillation (/flutter) within 12 months after patient's inclusion [ Time Frame: 24 months after study start ]
    Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint but within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
  • number of atrial fibrillation (/flutter) without hospitalisation [ Time Frame: 30 months after study start ]
    Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint with the exception that hospitalisation for atrial fibrillation (/flutter) will be considered as censoring.
  • number of recurrent stroke or systemic embolism [ Time Frame: 24 months after study start ]
    Recurrent stroke or systemic embolism within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
  • total mortality [ Time Frame: 24 months after study start ]
    Total death within 12 months after patient's inclusion. As patients are recruited for 12 months, this outcome measure is determined 24 months after study start.
  • number of cardiovascular deaths [ Time Frame: 24 months after study start ]
  • number of cerebrovascular deaths [ Time Frame: 24 months after study start ]
  • number of transient ischemic attacks [ Time Frame: 24 months after study start ]
  • number of myocardial infarctions [ Time Frame: 24 months after study start ]
  • number of bleeding complications [ Time Frame: 24 months after study start ]
  • quality of life [ Time Frame: 24 months after study start ]
  • number of atrial fibrillation (/flutter) in extended monitoring period [ Time Frame: 24 months after study start ]
    Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months.
  • costs [ Time Frame: 24 months after study start ]
  • number of correct monitorings [ Time Frame: 24 months after study start ]
    To assess the feasibility of monitoring procedures.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
  • number of atrial fibrillation (/flutter) within 12 months [ Time Frame: 24 months after study start ]
    Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint but within 12 months.
  • number of atrial fibrillation (/flutter) without hospitalisation [ Time Frame: 30 months after study start ]
    Detection of newly diagnosed atrial fibrillation (/flutter) as defined for the primary endpoint with the exception that hospitalisation for atrial fibrillation (/flutter) will be considered as censoring.
  • number of recurrent stroke or systemic embolism [ Time Frame: 24 months after study start ]
    Recurrent stroke or systemic embolism after 12 months.
  • total mortality [ Time Frame: 24 months after study start ]
    Total death after 12 months.
  • number of cardiovascular deaths [ Time Frame: 24 months after study start ]
  • number of cerebrovascular deaths [ Time Frame: 24 months after study start ]
  • number of transient ischemic attacks [ Time Frame: 24 months after study start ]
  • number of myocardial infarctions [ Time Frame: 24 months after study start ]
  • number of bleeding complications [ Time Frame: 24 months after study start ]
  • quality of life [ Time Frame: 24 months after study start ]
  • number of atrial fibrillation (/flutter) in extended monitoring period [ Time Frame: 24 months after study start ]
    Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months.
  • costs [ Time Frame: 24 months after study start ]
  • number of correct monitorings [ Time Frame: 24 months after study start ]
    To assess the feasibility of monitoring procedures.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring
Official Title  ICMJE A Prospective, Randomised, Controlled Study to Determine the Detection of Atrial Fibrillation by Prolonged and Enhanced Holter Monitoring as Compared to Usual Care in Stroke Patients
Brief Summary The purpose of this study is to assess whether repeated enhanced and prolonged ECG monitoring after ischemic stroke results in a higher detection of atrial fibrillation (/flutter) compared to usual care (at least 24 hour of cardiac monitoring).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Stroke
Intervention  ICMJE
  • Other: prolonged ECG monitoring
    10-day Holter ECG measurement
  • Other: standard care
    Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
Study Arms  ICMJE
  • Experimental: prolonged ECG monitoring
    Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6
    Intervention: Other: prolonged ECG monitoring
  • standard care
    Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
    Intervention: Other: standard care
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  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 15, 2013)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging.
  • Stroke symptoms started ≤ 7 days ago.
  • Age ≥ 60 years.
  • Modified Rankin scale ≤ 2 (prior to index event).

Exclusion Criteria:

  • Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.
  • Indication for oral anticoagulation at randomisation.
  • Absolute contra-indication against oral anticoagulation at randomisation.
  • Intracerebral bleeding in medical history.
  • Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours.
  • Significant carotid artery or vertebral artery stenosis > 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms.
  • Implanted pacemaker device or cardioverter/defibrillator.
  • Life expectancy < 1 year for reasons other than stroke (e.g. metastatic cancer).
  • Concomitant participation in other controlled randomised trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01855035
Other Study ID Numbers  ICMJE Find-AF randomised
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Study Sponsor  ICMJE Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rolf Wachter, PD Dr. med. Dept. of Cardiology and Pneumology, University Medical Center Goettingen
Principal Investigator: Klaus Gröschel, PD Dr.med. Clinic and Policlinic for Neurology, University of Mainz
PRS Account Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP