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
  Purpose

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).


Condition Intervention
Stroke
Other: prolonged ECG monitoring
Other: standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prolonged ECG monitoring
Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6
Other: prolonged ECG monitoring
10-day Holter ECG measurement
standard care
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
Other: standard care
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01855035

Locations
Germany
Dept. of Cardiology and Pneumology, University Medical Center Goettingen Recruiting
Goettingen, Germany, 37075
Contact: Wachter, PD Dr. med.    +49-551-39-9258    wachter@med.uni-goettingen.de   
Principal Investigator: Rolf Wachter, PD Dr. med.         
Sub-Investigator: Jan Liman, Dr.         
Sub-Investigator: Katrin Wasser, Dr.         
Sub-Investigator: Janin Wohlfahrt         
Sub-Investigator: Mark Weber-Krüger         
Clinic and Policlinic for Neurology, University of Mainz Recruiting
Mainz, Germany, 55131
Contact: Klaus Gröschel, PD Dr. med.    +49-6131-173105    Klaus.groeschel@unimedizin-mainz.de   
Principal Investigator: Klaus Gröschel, PD Dr. med.         
Sub-Investigator: Anne Grings         
Dept. of Neurology, Nordwest-Hospital Sanderbusch Recruiting
Sande, Germany, 26452
Contact: Pawel Kermer, Prof. Dr. med.    +49-4422-801401    p.kermer@sanderbusch.de   
Principal Investigator: Pawel Kermer, Prof. Dr. med.         
Sub-Investigator: Evgeny Protsenko         
Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital Recruiting
Wiesbaden, Germany, 65199
Contact: Gerhard Hamann, Prof. Dr. med.    +49-611-43-2376    gerhard.hamann@hsk-wiesbaden.de   
Principal Investigator: Gerhard Hamann, Prof. Dr. med.         
Sub-Investigator: Michaela Wagner-Heck, Dr.         
Sub-Investigator: Jugoslav Erceg         
Sub-Investigator: Joachim Hüwel, Dr.         
Sub-Investigator: Sven Klimpe, Dr.         
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Investigators
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
  More Information

No publications provided

Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier: NCT01855035     History of Changes
Other Study ID Numbers: Find-AF randomised
Study First Received: May 7, 2013
Last Updated: October 28, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
ischemic stroke
ECG monitoring
atrial fibrillation (/flutter)

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

ClinicalTrials.gov processed this record on August 20, 2014