Intensive Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study (Find-AF2)

January 26, 2023 updated by: Rolf Wachter, University of Leipzig

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

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.

Study Overview

Detailed Description

The Find AF 2 study will investigate whether intensified rhythm monitoring in patients with recent ischemic stroke leads to a decrease in recurrent thromboembolism (defined as recurrent ischemic stroke or systemic embolism). This will be achieved by identifying patients with paroxysmal atrial fibrillation and subsequently switching secondary prevention therapy from antiplatelet therapy to oral anticoagulation. The intensity of heart rhythm monitoring will be risk-adjusted: Patients with an estimated low risk of atrial fibrillation receive a 7-day Holter ECG, which is repeated after 3 and 12 months and annually thereafter. Patients with a high risk of atrial fibrillation (defined by increased supraventricular ectopic activity) receive continuous ECG monitoring using an implanted loop recorder. The control arm is treated according to local standards, which includes cardiac rhythm monitoring for at least 24 hours according to current guidelines. Prior to randomization, a 24-hour Holter ECG is performed in both study arms, ensuring minimal ECG monitoring for patients in the control arm and allowing risk stratification in the intervention arm. Additional ECG monitoring using stroke telemetry and/or additional Holter ECGs is possible according to local standards, provided it does not exceed 7 days. Patients in both study arms will be followed up for at least 24 months.

It should be noted that this study only provides diagnostic information, the therapeutic decision is left to the treating physician.

Study Type

Interventional

Enrollment (Anticipated)

5200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Altenburg, Germany
        • Recruiting
        • Klinikum Altenburger Land
        • Contact:
          • Jörg Berrouschot, Prof. Dr.
      • Aschaffenburg, Germany
        • Recruiting
        • Klinikum Aschaffenburg-Alzenau
        • Contact:
          • Oliver Bähr, Prof. Dr.
      • Augsburg, Germany
        • Recruiting
        • Universitätsklinikum Augsburg
        • Contact:
          • Michael Ertl, PD Dr.
      • Bad Neustadt An Der Saale, Germany
        • Recruiting
        • Rhön Klinikum Campus Bad Neustadt
        • Contact:
          • Hassan Soda, Dr.
      • Bamberg, Germany
        • Recruiting
        • Sozialstiftung Bamberg; Klinikum am Bruderwald
        • Contact:
          • Herwig Strik, Prof. Dr.
      • Berlin, Germany
        • Recruiting
        • BG Klinikum, Unfall-KH Berlin gGmbH
        • Contact:
          • Mirko Seidel, Dr.
      • Berlin, Germany
        • Recruiting
        • Vivantes Klinikum Neukölln Berlin
        • Contact:
          • Darius G Nabavi, Prof. Dr.
      • Berlin, Germany
        • Recruiting
        • Vivantes, Humboldt-Klinikum Berlin
        • Contact:
          • Bettina Schmitz, Prof. Dr.
      • Berlin-Spandau, Germany
        • Recruiting
        • Vivantes Klinikum Spandau
        • Contact:
          • Jörg Müller, Prof. Dr.
      • Bielefeld, Germany, 33611
        • Recruiting
        • Evangelisches Klinikum Bethel, Klinik für Neurologie
        • Contact:
          • Wolf R Schäbitz, Prof. Dr.
      • Bonn, Germany
        • Recruiting
        • Universitatsklinikum Bonn
        • Contact:
          • Gabor Petzold, Prof. Dr.
      • Bremen, Germany
        • Recruiting
        • Klinikum Bremen Mitte
        • Contact:
          • Andreas Kastrup, Prof. Dr.
      • Coburg, Germany, 96450
        • Recruiting
        • Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie
        • Contact:
          • Christian Mahnkopf, Dr.
      • Darmstadt, Germany
        • Recruiting
        • Klinikum Darmstadt
        • Contact:
          • Rainer Kollmar, Prof. Dr.
      • Dresden, Germany
        • Recruiting
        • Städtisches Klinikum Dresden, Standort Friedrichstadt
        • Contact:
          • Sebastian Schellong, Prof. Dr.
      • Dresden, Germany
        • Recruiting
        • Universitätsklinikum Carl Gustav Carus
        • Contact:
          • Lars P Pallesen, Dr.
      • Erlangen, Germany
        • Recruiting
        • Universitatsklinikum Erlangen
        • Contact:
          • Bernd Kallmünzer, PD Dr.
      • Essen, Germany, 45147
        • Recruiting
        • University of Essen, Clinic for Neurology
        • Contact:
          • Martin Köhrmann, Prof. Dr.
      • Frankfurt, Germany
        • Recruiting
        • Universitatsklinikum Frankfurt
        • Contact:
          • Natalia Kurka, Dr.
      • Frankfurt, Germany
        • Recruiting
        • Klinikum Frankfurt Höchst
        • Contact:
          • Thorsten Steiner, Prof. Dr.
      • Fulda, Germany
        • Recruiting
        • Klinikum Fulda
        • Contact:
          • Tobias Neumann-Haefelin, Prof. Dr.
      • Gießen, Germany
        • Recruiting
        • Universitätsklinikum Giessen und Marburg GmbH
        • Contact:
          • Martin Jünemann, Dr.
        • Contact:
          • Hagen Huttner, Prof. Dr.
      • Göttingen, Germany, 37075
        • Recruiting
        • University of Göttingen, Clinic for Neurology
        • Contact:
          • Jan Liman, Prof. Dr.
      • Günzburg, Germany
        • Recruiting
        • Bezirkskrankenhaus Günzburg
        • Contact:
          • Gerhard F Hamann, Prof.
      • Halle, Germany
        • Recruiting
        • Krankenhaus Martha-Maria Halle-Dölau
        • Contact:
          • Frank Hoffmann, Dr.
      • Hamburg, Germany
        • Recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:
          • Götz Thomalla, Prof. Dr.
      • Hamburg, Germany
        • Recruiting
        • Albertinenkrankenhaus Hamburg
        • Contact:
          • Michael Rosenkranz, PD Dr.
      • Hamburg, Germany
        • Recruiting
        • Asklepios Klinik Altona Hamburg
        • Contact:
          • Joachim Röther, Prof. Dr.
      • Hamburg, Germany
        • Recruiting
        • Asklepios Klinik Wandsbek, Hamburg
        • Contact:
          • Lars Marquardt, PD Dr. Dr.
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Karin Weißenborn, Prof. Dr.
      • Heidelberg, Germany
        • Recruiting
        • UniversitatsKlinikum Heidelberg
        • Contact:
          • Peter A. Ringleb, Prof. Dr.
      • Höxter, Germany
        • Recruiting
        • Klinikum Höxter
        • Contact:
          • Mark Obermann, Prof. Dr.
      • Ibbenbüren, Germany
        • Recruiting
        • Klinikum Ibbenbüren
        • Contact:
          • Florian Bethke, Dr.
      • Kaiserslautern, Germany
        • Withdrawn
        • Westpfalz Klinikum GmbH - Standort Kaiserslautern
      • Leipzig, Germany
        • Terminated
        • Klinikum St. Georg Leipzig
      • Lüneburg, Germany
        • Recruiting
        • Städtisches Klinikum Lüneburg gemeinnützige GmbH
        • Contact:
          • Waltraud Pfeilschifter, Prof. Dr.
      • Mainz, Germany, 55131
        • Recruiting
        • University of Mainz, Clinic for Neurology
        • Contact:
          • Klaus Gröschel, Prof. Dr.
      • Mannheim, Germany
        • Withdrawn
        • Universitätsklinikum Mannheim
      • Merseburg, Germany
        • Recruiting
        • Carl-von-Basedow Klinikum Merseburg
        • Contact:
          • Carsten Hobohm, Dr.
      • Minden, Germany
        • Recruiting
        • Klinikum Minden
        • Contact:
          • Peter Schellinger, Prof. Dr.
      • Mühlhausen, Germany
        • Recruiting
        • Ökumenisches Hainich Klinikum Mühlhausen
        • Contact:
          • Marek Jauß, Prof. Dr.
      • Münster, Germany
        • Recruiting
        • Universitätsklinikum Münster
        • Contact:
          • Jens Minnerup, Prof. Dr.
      • Osnabrück, Germany
        • Recruiting
        • Klinikum Osnabrück GmbH
        • Contact:
          • Lars U Krause, Dr.
      • Passau, Germany
        • Recruiting
        • Klinikum Passau
        • Contact:
          • Tobias Freilinger, Prof. Dr.
      • Sande, Germany, 26452
        • Recruiting
        • Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie
        • Contact:
          • Pawel Kermer, Prof. Dr.
      • Siegen, Germany
        • Recruiting
        • Kreisklinikum Siegen
        • Contact:
          • Martin Grond, Prof. Dr.
      • Traunstein, Germany
        • Recruiting
        • Kliniken Südostbayern AG, Klinikum Traunstein
        • Contact:
          • Thorleif Etgen, Prof. Dr.
      • Tübingen, Germany
        • Recruiting
        • Universitatsklinikum Tubingen
      • Ulm, Germany
        • Recruiting
        • Universitatsklinikum Ulm
        • Contact:
          • Katharina Althaus, Dr.
      • Wiesbaden, Germany
        • Recruiting
        • Helios Dr. Horst Schmidt-Kliniken Wiesbaden
        • Contact:
          • Frank A Wollenweber, Prof. Dr.
      • Würzburg, Germany
        • Recruiting
        • Universitatsklinikum Wurzburg
        • Contact:
          • Karl G Häusler, Prof. Dr.
    • Bayern
      • München, Bayern, Germany
        • Recruiting
        • ISD München
        • Contact:
          • Martin Dichgans, Prof. Dr.
      • Nürnberg, Bayern, Germany, 90471
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • Recruiting
        • University of Leipzig, Clinic for Neurology
        • Contact:
          • Dominik Michalski, Prof. Dr.
        • Contact:
          • Rolf Wachter, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Age ≥ 60 years
  3. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symptoms.
  4. Written informed consent

Exclusion Criteria:

  1. Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG
  2. Current indication or contraindication for oral anticoagulation at randomisation
  3. Intracerebral bleeding in medical history
  4. Patient scheduled for ECG-monitoring lasting > 7 days (Holter-ECG, implanted loop recorder, etc.)
  5. Implanted pacemaker device or cardioverter/ defibrillator
  6. Patient not willing to be treated with oral anticoagulants
  7. Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.
  8. History of carotid endarterectomy or percutaneous intervention of cerebral artery within the last 30 days.
  9. Life expectancy <1 year for reasons other than stroke (e.g. metastatic cancer)
  10. patients under legal supervision or guardianship
  11. 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
  12. participation in other randomised interventional trials
  13. suspected lack of compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risk-adapted ECG monitoring for atrial fibrillation

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

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)
Continuous rhythm monitoring using an implantable cardiac monitor
Other: Standard of Care
Standard of care rhythm monitoring
Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism
Time Frame: 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
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 Frame: from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time until the combination of stroke, myocardial infarction and cardiovascular death
Time Frame: 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 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
Time Frame: from the date of randomization until the date of first documented any stroke, 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
Time Frame: from the date of randomization until the date of first documented AF, assessed up to 60 months
Time until new onset of Atrial Fibrillation
from the date of randomization until the date of first documented AF, assessed up to 60 months
Time until all cause mortality
Time Frame: from the date of randomization until the date of all cause mortality 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
Time Frame: from the date of randomization until the date of all myocardial infarction, 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
Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16)
Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16). The SIS-16 ranges from 16 to 80, with higher scores showing better Quality of life.
Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in the EQ-5D five dimensional Quality of Life (QoL)
Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in the EQ-5D five dimensional Quality of Life (QoL)
Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in the overall QoL visual analog scale
Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms, ranging from 0 to 100, with higher values indicating better quality of life
Changes in the overall QoL visual analog scale
Mean change from baseline until study end assessed up to 60 months in both study arms, ranging from 0 to 100, with higher values indicating better quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Rolf Wachter, Prof. Dr., University of Leipzig, Clinic and Policlinis for Cardiology
  • Principal Investigator: Klaus Gröschel, Prof. Dr., University of Mainz, Clinic and Policlinis for Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2020

Primary Completion (Anticipated)

June 30, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 30, 2020

First Posted (Actual)

May 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

after publication of the major results

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Stroke

Clinical Trials on 7-day Holter ECG

3
Subscribe