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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855035
• Other study ID #: Find-AF randomised
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: November 2017

Study information

• Verified date: April 2020
• Source: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Other:
• prolonged ECG monitoring
10-day Holter ECG measurement
• standard care
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Locations

Country	Name	City	State
Germany	Dept. of Cardiology and Pneumology, University Medical Center Goettingen	Goettingen
Germany	Clinic and Policlinic for Neurology, University of Mainz	Mainz
Germany	Dept. of Neurology, Nordwest-Hospital Sanderbusch	Sande
Germany	Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Wachter R, Gröschel K, Gelbrich G, Hamann GF, Kermer P, Liman J, Seegers J, Wasser K, Schulte A, Jürries F, Messerschmid A, Behnke N, Gröschel S, Uphaus T, Grings A, Ibis T, Klimpe S, Wagner-Heck M, Arnold M, Protsenko E, Heuschmann PU, Conen D, Weber-Krüger M; Find-AF(randomised) Investigators and Coordinators. Holter-electrocardiogram-monitoring in patients with acute ischaemic stroke (Find-AF(RANDOMISED)): an open-label randomised controlled trial. Lancet Neurol. 2017 Apr;16(4):282-290. doi: 10.1016/S1474-4422(17)30002-9. Epub 2017 Feb 8. Erratum in: Lancet Neurol. 2017 Apr;16(4):261. — View Citation

Weber-Krüger M, Gelbrich G, Stahrenberg R, Liman J, Kermer P, Hamann GF, Seegers J, Gröschel K, Wachter R; Find-AF(RANDOMISED) investigators. Finding atrial fibrillation in stroke patients: Randomized evaluation of enhanced and prolonged Holter monitoring--Find-AF(RANDOMISED) --rationale and design. Am Heart J. 2014 Oct;168(4):438-445.e1. doi: 10.1016/j.ahj.2014.06.018. Epub 2014 Jul 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of atrial fibrillation/flutter	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.	30 month after study start
Secondary	number of atrial fibrillation (/flutter) within 12 months after patient's inclusion	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.	24 months after study start
Secondary	number of atrial fibrillation (/flutter) without hospitalisation	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.	30 months after study start
Secondary	number of recurrent stroke or systemic embolism	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.	24 months after study start
Secondary	total mortality	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.	24 months after study start
Secondary	number of cardiovascular deaths		24 months after study start
Secondary	number of cerebrovascular deaths		24 months after study start
Secondary	number of transient ischemic attacks		24 months after study start
Secondary	number of myocardial infarctions		24 months after study start
Secondary	number of bleeding complications		24 months after study start
Secondary	quality of life		24 months after study start
Secondary	number of atrial fibrillation (/flutter) in extended monitoring period	Incremental detection of atrial fibrillation (/flutter) in the extended Holter monitoring periods after 3 and 6 months.	24 months after study start
Secondary	costs		24 months after study start
Secondary	number of correct monitorings	To assess the feasibility of monitoring procedures.	24 months after study start