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Completed

NCT Number: NCT01855035

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

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).

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Key information

Conditions

Stroke Arrhythmias, Cardiac Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Cardiology and Pneumology, University Medical Center Goettingen, Göttingen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

prolonged ECG monitoring

Other

10-day Holter ECG measurement

Standard care

Other

Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 16, 2013
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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