Intensive Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study

NCT04371055 | Active Not Recruiting DMC

• 1 other identifier: Find-AF 2
• Study Type: interventional
• Target: 5,227
• Locations: 1 country
• Sites: 52

Brief Summary

Patients who have suffered a stroke are having an increased risk of having recurrent stroke in the future. This risk of stroke is increased by atrial fibrillation, which often "comes and goes" (called paroxysmal) and hence escapes routine diagnostics. The hypothesis of Find-AF 2 is that enhanced (evaluation in a ECG core lab), prolonged (at least 7 days of rhythm monitoring annually) and intensified (continuous rhythm monitoring in high risk patients) not only finds atrial fibrillation more often, but that changes in therapeutic management (e. g. start of anticoagulation after detection of atrial fibrillation) results in a decrease of cardioembolism (which can be either recurrent stroke or systemic embolism). To prove this hypothesis, patients will be randomised into two groups: the first group will receive the currently available standard care for patients with stroke. In the second group, cardiac rhythm monitoring adapted to the risk of the occurrence of atrial fibrillation is performed - either with a 7-day long-term ECG (at baseline, after 3 and 12 months and every 12 months thereafter) or with continuous monitoring using an implantable cardiac monitor. If atrial fibrillation is detected, this information will be given to the treating study physician. Any therapeutic decision is at the discretion of the treating physician, but should follow current guidelines.

Conditions

Ischemic Stroke; Atrial Fibrillation

Keywords

Atrial Fibrillation; Ischemic Stroke; ECG Monitoring; Secondary Prevention

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism

  The trial will be event driven. The minimum follow-up in each patient is 24 months, but may be followed for up to 60 months.

  from the date of randomization until the date of first documented ischemic stroke or date of first systemic embolism, whichever comes first, assessed up to 60 months

• Primary safety endpoint: Time until the first haemorrhagic stroke

  Time until the first haemorrhagic stroke

  from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months

Secondary Outcomes (8)

• Time until the combination of stroke, myocardial infarction and cardiovascular death

  from the date of randomization until the date of first documented stroke, the date of myocardial infarction and the date of cardiovascular death, whichever comes first, assessed up to 60 months

• Time until any stroke

  from the date of randomization until the date of first documented any stroke, assessed up to 60 months

• Time until new onset of AF

  from the date of randomization until the date of first documented AF, assessed up to 60 months

• Time until all cause mortality

  from the date of randomization until the date of all cause mortality assessed up to 60 months

• Time until myocardial infarction

  from the date of randomization until the date of all myocardial infarction, assessed up to 60 months

Study Arms (2)

Risk-adapted ECG monitoring for atrial fibrillation

EXPERIMENTAL

Intervention Group with high Risk for AF: Continuous Rhythm Monitoring using an implantable cardiac Monitor Intervention group with low risk for AF: 7-day Holter ECG at baseline, after 3 and 12 months and then annually until the end of the study or the first occurrence of atrial Fibrillation

Other: 7-day Holter ECG; Other: Implantable cardiac monitor

Standard of Care

OTHER

Standard of care rhythm monitoring

Other: Standard of care

Interventions

7-day Holter ECG OTHER

7-day Holter ECG at baseline and after 3 and 12 months and then annually until the end of the study or the first (in patients with low risk of atrial fibrillation)

Risk-adapted ECG monitoring for atrial fibrillation

Implantable cardiac monitor OTHER

Continuous rhythm monitoring using an implantable cardiac monitor

Risk-adapted ECG monitoring for atrial fibrillation

Standard of care OTHER

Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)

Standard of Care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent ischemic stroke (sudden focal neurologic deficit lasting \> 24h consistent with the territory of a major cerebral artery) and/or a corresponding lesion on brain imaging within the last 30 days
• Age ≥ 60 years
• Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symptoms.
• Written informed consent

You may not qualify if:

• Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG
• Current indication or contraindication for oral anticoagulation at randomisation
• Intracerebral bleeding in medical history
• Patient scheduled for ECG-monitoring lasting \> 7 days (Holter-ECG, implanted loop recorder, etc.)
• Implanted pacemaker device or cardioverter/ defibrillator
• Patient not willing to be treated with oral anticoagulants
• Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.
• History of carotid endarterectomy or percutaneous intervention of cerebral artery within the last 30 days.
• Life expectancy \<1 year for reasons other than stroke (e.g. metastatic cancer)
• patients under legal supervision or guardianship
• psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties,...) or participate in the required tests
• participation in other randomised interventional trials
• suspected lack of compliance

Sponsors & Collaborators

• University of Leipzig: lead
• Johannes Gutenberg University Mainz: collaborator

Study Sites (52)

ISD München

München, Bavaria, Germany

Location

Klinikum Nürnberg

Nuremberg, Bavaria, 90471, Germany

Location

Klinikum Bremen Mitte

Bremen, City state Bremen, Germany

Location

University of Leipzig, Clinic for Neurology

Leipzig, Saxony, 04103, Germany

Location

Vivantes Klinikum Neukölln Berlin

Berlin, State of Berlin, Germany

Location

Klinikum Altenburger Land

Altenburg, Germany

Location

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, Germany

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Rhön Klinikum Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Location

Sozialstiftung Bamberg; Klinikum am Bruderwald

Bamberg, Germany

Location

BG Klinikum, Unfall-KH Berlin gGmbH

Berlin, Germany

Location

Vivantes, Humboldt-Klinikum Berlin

Berlin, Germany

Location

Vivantes Klinikum Spandau

Berlin-Spandau, Germany

Location

Evangelisches Klinikum Bethel, Klinik für Neurologie

Bielefeld, 33611, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie

Coburg, 96450, Germany

Location

Klinikum Darmstadt

Darmstadt, Germany

Location

Städtisches Klinikum Dresden, Standort Friedrichstadt

Dresden, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

University of Essen, Clinic for Neurology

Essen, 45147, Germany

Location

Klinikum Frankfurt Höchst

Frankfurt, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Klinikum Fulda

Fulda, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, Germany

Location

University of Göttingen, Clinic for Neurology

Göttingen, 37075, Germany

Location

Bezirkskrankenhaus Günzburg

Günzburg, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau

Halle, Germany

Location

Albertinenkrankenhaus Hamburg

Hamburg, Germany

Location

Asklepios Klinik Altona Hamburg

Hamburg, Germany

Location

Asklepios Klinik Wandsbek, Hamburg

Hamburg, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, Germany

Location

Klinikum Höxter

Höxter, Germany

Location

Klinikum Ibbenbüren

Ibbenbueren, Germany

Location

Klinikum St. Georg Leipzig

Leipzig, Germany

Location

Städtisches Klinikum Lüneburg gemeinnützige GmbH

Lüneburg, Germany

Location

University of Mainz, Clinic for Neurology

Mainz, 55131, Germany

Location

Carl-von-Basedow Klinikum Merseburg

Merseburg, Germany

Location

Klinikum Minden

Minden, Germany

Location

Ökumenisches Hainich Klinikum Mühlhausen

Mühlhausen, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Klinikum Osnabrück GmbH

Osnabrück, Germany

Location

Klinikum Passau

Passau, Germany

Location

Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie

Sande, 26452, Germany

Location

Kreisklinikum Siegen

Siegen, Germany

Location

Kliniken Südostbayern AG, Klinikum Traunstein

Traunstein, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Helios Dr. Horst Schmidt-Kliniken Wiesbaden

Wiesbaden, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Related Publications (2)

• Uhe T, Wasser K, Weber-Kruger M, Schabitz WR, Kohrmann M, Brachmann J, Laufs U, Dichgans M, Gelbrich G, Petroff D, Prettin C, Michalski D, Kraft A, Etgen T, Schellinger PD, Soda H, Bethke F, Ertl M, Kallmunzer B, Grond M, Althaus K, Hamann GF, Mende M, Wagner M, Groschel S, Uphaus T, Groschel K, Wachter R; Find-AF 2 study group. Intensive heart rhythm monitoring to decrease ischemic stroke and systemic embolism-the Find-AF 2 study-rationale and design. Am Heart J. 2023 Nov;265:66-76. doi: 10.1016/j.ahj.2023.06.016. Epub 2023 Jul 7.

  PMID: 37422010 BACKGROUND

• Wasser K, Uhe T, Schabitz WR, Kohrmann M, Dichgans M, Brachmann J, Laufs U, Gelbrich G, Petroff D, Prettin C, Michalski D, Pelz J, Kraft A, Etgen T, Soda H, Bethke F, Schellinger PD, Althaus K, Hamann GF, Grond M, Kallmunzer B, Petersen M, Pallesen LP, Ertl M, Zickler P, Poli S, Haeusler KG, Steiner T, Sparenberg P, Kermer P, Kopczak A, Kellert L, Nuckel M, Liman J, Ringleb PA, Mende M, Wagner M, Bochert D, Schnieder M, Amanzada I, Groschel S, Hahn M, Uphaus T, Groschel K, Wachter R; Find-AF 2 study group. Baseline characteristics of patients with acute ischaemic stroke included in the randomised controlled Find-AF 2 trial. Neurol Res Pract. 2025 Jun 26;7(1):45. doi: 10.1186/s42466-025-00399-8.

  PMID: 40571918 DERIVED

Related Links

• Study homepage with information for medical experts and the general public

MeSH Terms

Conditions

Ischemic Stroke; Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Rolf Wachter, Prof. Dr.

  University of Leipzig, Clinic and Policlinis for Cardiology

  STUDY CHAIR

• Klaus Gröschel, Prof. Dr.

  University of Mainz, Clinic and Policlinis for Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor for Clinical and Interventional Cardiology

Model Details: Randomised, parallel, multicenter interventional trial with blinded assessment of the primary endpoint

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 1, 2020
• Study Start: July 7, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after publication of the major results

Locations

DE (52)