NCT01855035

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

4.3 years

First QC Date

May 7, 2013

Last Update Submit

April 30, 2020

Conditions

Stroke

Keywords

ischemic strokeECG monitoringatrial fibrillation (/flutter)

Outcome Measures

Primary Outcomes (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.

    30 month after study start

Secondary Outcomes (13)

  • number of atrial fibrillation (/flutter) within 12 months after patient's inclusion

    24 months after study start

  • number of atrial fibrillation (/flutter) without hospitalisation

    30 months after study start

  • number of recurrent stroke or systemic embolism

    24 months after study start

  • total mortality

    24 months after study start

  • number of cardiovascular deaths

    24 months after study start

  • +8 more secondary outcomes

Study Arms (2)

prolonged ECG monitoring

EXPERIMENTAL

Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6

Other: prolonged ECG monitoring

standard care

OTHER

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

Other: standard care

Interventions

prolonged ECG monitoringOTHER

10-day Holter ECG measurement

prolonged ECG monitoring
standard careOTHER

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

standard care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dept. of Cardiology and Pneumology, University Medical Center Goettingen

Göttingen, 37075, Germany

Location

Clinic and Policlinic for Neurology, University of Mainz

Mainz, 55131, Germany

Location

Dept. of Neurology, Nordwest-Hospital Sanderbusch

Sande, 26452, Germany

Location

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

Wiesbaden, 65199, Germany

Location

Related Publications (5)

  • 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.

    PMID: 28187920BACKGROUND

  • 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.

    PMID: 25262252BACKGROUND

  • 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.

    PMID: 33421630DERIVED

  • 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.

    PMID: 31813354DERIVED

  • 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.

    PMID: 31071137DERIVED

MeSH Terms

Conditions

StrokeIschemic StrokeAtrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 16, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2017

Study Completion

November 1, 2017

Last Updated

May 4, 2020

Record last verified: 2020-04

Locations

DE(4)