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StrokeNCT01855035

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

A study testing prolonged ECG monitoring in people with Stroke, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Stroke
What is being tested?
prolonged ECG monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
4 sitesGermany
Study dates
May 2013to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Dept. of Cardiology and Pneumology, University Medical Center Goettingen

    Göttingen, 37075

  • Clinic and Policlinic for Neurology, University of Mainz

    Mainz, 55131

  • Dept. of Neurology, Nordwest-Hospital Sanderbusch

    Sande, 26452

  • Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital

    Wiesbaden, 65199

Other trials in Germany

About this study

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

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).

Conditions
Stroke
Being tested
prolonged ECG monitoring, standard care
Keywords
ischemic stroke, ECG monitoring, atrial fibrillation (/flutter)
Medical subject headings
Stroke, Ischemic Stroke, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • prolonged ECG monitoringOther

    10-day Holter ECG measurement

  • standard careOther

    Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).

Study groups in NCT01855035
Study groupRoleWhat they receive
prolonged ECG monitoringExperimentalProlonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6
Receives: Other: prolonged ECG monitoring
standard careOtherUsual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
Receives: Other: standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 month after study start

Secondary outcomes (13)

  1. 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.

    Measured: 24 months after study start

  2. 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.

    Measured: 30 months after study start

  3. 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.

    Measured: 24 months after study start

  4. 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.

    Measured: 24 months after study start

  5. number of cardiovascular deaths

    Measured: 24 months after study start

  6. number of cerebrovascular deaths

    Measured: 24 months after study start

  7. number of transient ischemic attacks

    Measured: 24 months after study start

  8. number of myocardial infarctions

    Measured: 24 months after study start

  9. number of bleeding complications

    Measured: 24 months after study start

  10. quality of life

    Measured: 24 months after study start

  11. 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.

    Measured: 24 months after study start

  12. costs

    Measured: 24 months after study start

  13. number of correct monitorings

    To assess the feasibility of monitoring procedures.

    Measured: 24 months after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionSep 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01855035
Sponsor's protocol ID
Find-AF randomised
Status last verified
Apr 2020
First submitted
7 May 2013
Last updated
4 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 28187920

  • 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.

    PubMed 25262252

  • Weber-Kruger M, Zapf A, Protsenko E, Liman J, Hamann GF, Kermer P, Wasser K, Uphaus T, Groschel S, Groschel K, Wachter R. Evaluation of predictors indicating paroxysmal atrial fibrillation in patients with acute ischemic strokes: the Find-AFRANDOMISED trial. Neurol Res Pract. 2026 Feb 23;8(1):12. doi: 10.1186/s42466-026-00471-x.

    PubMed 41731623

  • 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.

    PubMed 33421630

  • 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.

    PubMed 31813354

  • 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.

    PubMed 31071137

Questions about this trial

What is this clinical trial studying?

A study testing prolonged ECG monitoring in people with Stroke, run by Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of atrial fibrillation/flutter (time frame: 30 month after study start). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01855035, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.

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