Clinical trial NCT01855035: Finding Atrial Fibrillation in Stroke - Evaluation of Enhanced and Prolonged Holter Monitoring
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: ischemic stroke
ECG monitoring
atrial fibrillation (/flutter)
Lead sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 402
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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.

Primary outcomes:
measure: number of atrial fibrillation/flutter
timeFrame: 30 month after study start
Secondary outcomes:
measure: number of atrial fibrillation (/flutter) within 12 months after patient's inclusion
timeFrame: 24 months after study start
measure: number of atrial fibrillation (/flutter) without hospitalisation
timeFrame: 30 months after study start
measure: number of recurrent stroke or systemic embolism
timeFrame: 24 months after study start
measure: total mortality
timeFrame: 24 months after study start
measure: number of cardiovascular deaths
timeFrame: 24 months after study start
measure: number of cerebrovascular deaths
timeFrame: 24 months after study start
measure: number of transient ischemic attacks
timeFrame: 24 months after study start
measure: number of myocardial infarctions
timeFrame: 24 months after study start
measure: number of bleeding complications
timeFrame: 24 months after study start
measure: quality of life
timeFrame: 24 months after study start
measure: number of atrial fibrillation (/flutter) in extended monitoring period
timeFrame: 24 months after study start
measure: costs
timeFrame: 24 months after study start
measure: number of correct monitorings
timeFrame: 24 months after study start
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: Dept. of Cardiology and Pneumology, University Medical Center Goettingen
city: Mainz
country: Germany
facility: Clinic and Policlinic for Neurology, University of Mainz
city: Sande
country: Germany
facility: Dept. of Neurology, Nordwest-Hospital Sanderbusch
city: Wiesbaden
country: Germany
facility: Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital
Study officials:
affiliation: Dept. of Cardiology and Pneumology, University Medical Center Goettingen
name: Rolf Wachter, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic and Policlinic for Neurology, University of Mainz
name: Klaus Gröschel, PD Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wachter R, Groschel K, Gelbrich G, Hamann GF, Kermer P, Liman J, Seegers J, Wasser K, Schulte A, Jurries F, Messerschmid A, Behnke N, Groschel S, Uphaus T, Grings A, Ibis T, Klimpe S, Wagner-Heck M, Arnold M, Protsenko E, Heuschmann PU, Conen D, Weber-Kruger M; Find-AF(randomised) Investigators and Coordinators. Holter-electrocardiogram-monitoring in patients with acute ischaemic stroke (Find-AFRANDOMISED): 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.
citation: Weber-Kruger M, Gelbrich G, Stahrenberg R, Liman J, Kermer P, Hamann GF, Seegers J, Groschel 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.
citation: Sadlonova M, Wasser K, Nagel J, Weber-Kruger M, Groschel S, Uphaus T, Liman J, Hamann GF, Kermer P, Groschel K, Herrmann-Lingen C, Wachter R. Health-related quality of life, anxiety and depression up to 12 months post-stroke: Influence of sex, age, stroke severity and atrial fibrillation - A longitudinal subanalysis of the Find-AFRANDOMISED trial. J Psychosom Res. 2021 Mar;142:110353. doi: 10.1016/j.jpsychores.2020.110353. Epub 2021 Jan 2.
citation: Wasser K, Weber-Kruger M, Groschel S, Uphaus T, Liman J, Hamann GF, Kermer P, Seegers J, Binder L, Gelbrich G, Groschel K, Wachter R. Brain Natriuretic Peptide and Discovery of Atrial Fibrillation After Stroke: A Subanalysis of the Find-AFRANDOMISED Trial. Stroke. 2020 Feb;51(2):395-401. doi: 10.1161/STROKEAHA.119.026496. Epub 2019 Dec 9.
citation: Wasser K, Weber-Kruger M, Jurries F, Liman J, Hamann GF, Kermer P, Uphaus T, Protsenko E, Seegers J, Mende M, Groschel K, Wachter R. The cardiac diagnostic work-up in stroke patients-A subanalysis of the Find-AFRANDOMISED trial. PLoS One. 2019 May 9;14(5):e0216530. doi: 10.1371/journal.pone.0216530. eCollection 2019.