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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Sponsor:
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier:
NCT01855035
First received: May 7, 2013
Last updated: October 28, 2013
Last verified: May 2013

May 7, 2013
October 28, 2013
May 2013
May 2015   (final data collection date for primary outcome measure)
number of atrial fibrillation/flutter [ Time Frame: 30 month after study start ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01855035 on ClinicalTrials.gov Archive Site
  • number of atrial fibrillation (/flutter) within 12 months after patient's inclusion [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • number of cerebrovascular deaths [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of transient ischemic attacks [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of myocardial infarctions [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of bleeding complications [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of atrial fibrillation (/flutter) in extended monitoring period [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • number of correct monitorings [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
    To assess the feasibility of monitoring procedures.
  • number of atrial fibrillation (/flutter) within 12 months [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Recurrent stroke or systemic embolism after 12 months.
  • total mortality [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
    Total death after 12 months.
  • number of cardiovascular deaths [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of cerebrovascular deaths [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of transient ischemic attacks [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of myocardial infarctions [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of bleeding complications [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
  • number of atrial fibrillation (/flutter) in extended monitoring period [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • number of correct monitorings [ Time Frame: 24 months after study start ] [ Designated as safety issue: No ]
    To assess the feasibility of monitoring procedures.
Not Provided
Not Provided
 
Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring
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

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Stroke
  • 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).
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
November 2015
May 2015   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Germany
 
NCT01855035
Find-AF randomised
No
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Not Provided
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
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
May 2013

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