We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01855035
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Stroke Other: prolonged ECG monitoring Other: standard care Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. number of cardiovascular deaths [ Time Frame: 24 months after study start ]
  6. number of cerebrovascular deaths [ Time Frame: 24 months after study start ]
  7. number of transient ischemic attacks [ Time Frame: 24 months after study start ]
  8. number of myocardial infarctions [ Time Frame: 24 months after study start ]
  9. number of bleeding complications [ Time Frame: 24 months after study start ]
  10. quality of life [ Time Frame: 24 months after study start ]
  11. 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.

  12. costs [ Time Frame: 24 months after study start ]
  13. number of correct monitorings [ Time Frame: 24 months after study start ]
    To assess the feasibility of monitoring procedures.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01855035


Locations
Layout table for location information
Germany
Dept. of Cardiology and Pneumology, University Medical Center Goettingen
Goettingen, Germany, 37075
Clinic and Policlinic for Neurology, University of Mainz
Mainz, Germany, 55131
Dept. of Neurology, Nordwest-Hospital Sanderbusch
Sande, Germany, 26452
Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital
Wiesbaden, Germany, 65199
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Investigators
Layout table for investigator information
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
  Study Documents (Full-Text)

Documents provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
Study Protocol  [PDF] July 10, 2014

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier: NCT01855035    
Other Study ID Numbers: Find-AF randomised
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Keywords provided by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH:
ischemic stroke
ECG monitoring
atrial fibrillation (/flutter)
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes