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

April 30, 2020 updated by: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

402

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 Locations

  • Germany
      • Goettingen, Germany, 37075
        • Dept. of Cardiology and Pneumology, University Medical Center Goettingen
      • Mainz, Germany, 55131
        • Clinic and Policlinic for Neurology, University of Mainz
      • Sande, Germany, 26452
        • Dept. of Neurology, Nordwest-Hospital Sanderbusch
      • Wiesbaden, Germany, 65199
        • Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital

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:

  • 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.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: prolonged ECG monitoring
Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6
Other: prolonged ECG monitoring
10-day Holter ECG measurement
OTHER: standard care
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
Other: standard care
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of atrial fibrillation/flutter
Time Frame: 30 month after study start
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 Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Investigators

  • Principal Investigator: Rolf Wachter, PD Dr. med., Dept. of Cardiology and Pneumology, University Medical Center Goettingen
  • Principal Investigator: Klaus Gröschel, PD Dr.med., Clinic and Policlinic for Neurology, University of Mainz

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.

General Publications

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

May 1, 2013

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

May 15, 2013

First Posted (ESTIMATE)

May 16, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Find-AF randomised

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.

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