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

I

Institut für anwendungsorientierte Forschung und klinische Studien

Status

Completed

Conditions

Stroke

Treatments

Other: standard care
Other: prolonged ECG monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT01855035
Find-AF randomised

Details and patient eligibility

About

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).

Enrollment

402 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

402 participants in 2 patient groups

prolonged ECG monitoring
Experimental group
Description:
Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6
Treatment:
Other: prolonged ECG monitoring
standard care
Other group
Description:
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
Treatment:
Other: standard care

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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