Overview

This trial is active, not recruiting.

Condition stroke
Treatments prolonged ecg monitoring, standard care
Sponsor Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Start date May 2013
End date August 2014
Trial size 400 participants
Trial identifier NCT01855035, Find-AF randomised

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6
prolonged ecg monitoring
10-day Holter ECG measurement
(Other)
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
standard care
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Primary Outcomes

Measure
number of atrial fibrillation/flutter
time frame: 30 month after study start

Secondary Outcomes

Measure
number of atrial fibrillation (/flutter) within 12 months after patient's inclusion
time frame: 24 months after study start
number of atrial fibrillation (/flutter) without hospitalisation
time frame: 30 months after study start
number of recurrent stroke or systemic embolism
time frame: 24 months after study start
total mortality
time frame: 24 months after study start
number of cardiovascular deaths
time frame: 24 months after study start
number of cerebrovascular deaths
time frame: 24 months after study start
number of transient ischemic attacks
time frame: 24 months after study start
number of myocardial infarctions
time frame: 24 months after study start
number of bleeding complications
time frame: 24 months after study start
quality of life
time frame: 24 months after study start
number of atrial fibrillation (/flutter) in extended monitoring period
time frame: 24 months after study start
costs
time frame: 24 months after study start
number of correct monitorings
time frame: 24 months after study start

Eligibility Criteria

Male or female participants at least 60 years old.

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.

Additional Information

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
Principal investigator Rolf Wachter, PD Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH.