NCT02204267

Brief Summary

Investigator-initiated prospective randomized multicentre study to uncover the true burden of paroxysmal atrial fibrillation in a representative population of acute stroke patients without known atrial fibrillation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,470

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

5.4 years

First QC Date

July 29, 2014

Last Update Submit

November 11, 2020

Conditions

StrokeAtrial Fibrillation

Keywords

Strokeatrial fibrillationECG

Outcome Measures

Primary Outcomes (1)

  • Number of patients on oral anticoagulation (NOAC or VKA)

    Number of study patients on oral anticoagulation (NOAC or VKA) at 12 months after the index stroke either randomized to standardized prolonged ECG monitoring in-hospital or those randomized to usual stroke unit diagnostic procedures alone.

    12 months

Secondary Outcomes (1)

  • Number of stroke patients with newly detected atrial fibrillation

    7 days

Other Outcomes (2)

  • Impact of stroke unit level on the rate of atrial fibrillation detection

    7 days

  • Number of recurrent strokes, major bleeds, myocardial infarction and all-cause death (composite endpoint) within 6, 12 and 24 months after the index stroke

    24 months

Study Arms (2)

prolonged ECG monitoring

EXPERIMENTAL

Regular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring

Other: prolonged ECG monitoringDevice: ECG

no additional ECG recording

NO INTERVENTION

Regular stroke unit treatment and diagnostic procedures according to guidelines

Interventions

prolonged ECG monitoringOTHER

Start of long-term ECG immediately after admission to the stroke unit by using a portable ECG recorder for a max. duration of 7 days (or hospital discharge)

prolonged ECG monitoring
ECGDEVICE
prolonged ECG monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ischemic stroke or transitory ischemic attack (with clinical deficit on enrolment or MRI detected acute brain lesion on admission)
  • Age ≥ 18 years
  • Written or oral informed consent
  • Stroke unit admission within 72 hours after stroke onset
  • Start of standardized prolonged ECG monitoring within 24 hours after admission to the stroke unit
  • Willingness to take part in the planned follow up examinations

You may not qualify if:

  • Known atrial fibrillation
  • Atrial fibrillation detected by ECG on admission
  • Atrial fibrillation detected prior study enrollment on the stroke unit
  • Life expectancy \< 1 year (before actual stroke)
  • Life expectancy \< 1 month (after actual stroke)
  • Indication for oral anticoagulation other than atrial fibrillation (e.g. mechanical heart valve)
  • Severity level according National Institute of Health Stroke Scale (NIHSS) score \> 22
  • Participation in an interventional trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitaetsmedizin Berlin

Berlin, 12203, Germany

Location

Related Publications (7)

  • Haeusler KG, Tutuncu S, Fiessler C, Jawad-Ul-Qamar M, Kunze C, Schurig J, Dietzel J, Kramer M, Petzold GC, Royl G, Helberg T, Thomalla G, Nabavi DG, Rother J, Laufs U, Veltkamp R, Heuschmann PU, Kirchhof P, Olma MC, Endres M. Excessive Supraventricular Ectopic Activity in Patients With Acute Ischemic Stroke Is Associated With Atrial Fibrillation Detection Within 24 Months After Stroke: A Predefined Analysis of the MonDAFIS Study. J Am Heart Assoc. 2025 Jan 21;14(2):e034512. doi: 10.1161/JAHA.123.034512. Epub 2025 Jan 10.

    PMID: 39791425DERIVED

  • Tutuncu S, Olma MC, Kunze C, Dietzel J, Schurig J, Rosenkranz M, Stingele R, Maschke M, Heuschmann PU, Kirchhof P, Laufs U, Nabavi DG, Rother J, Thomalla G, Veltkamp R, Endres M, Haeusler KG; MonDAFIS Investigators. Heart failure, recurrent vascular events and death in patients with ischemic stroke-results of the MonDAFIS study. Intern Emerg Med. 2024 Aug;19(5):1247-1254. doi: 10.1007/s11739-024-03594-8. Epub 2024 Apr 15.

    PMID: 38619714DERIVED

  • Ingwersen T, Olma MC, Schlemm E, Mayer C, Cheng B, Tutuncu S, Kirchhof P, Veltkamp R, Rother J, Laufs U, Nabavi DG, Ntaios G, Endres M, Haeusler KG, Thomalla G. Independent external validation of a stroke recurrence score in patients with embolic stroke of undetermined source. Neurol Res Pract. 2023 Oct 5;5(1):51. doi: 10.1186/s42466-023-00279-z.

    PMID: 37794453DERIVED

  • Olma MC, Tutuncu S, Grittner U, Kunze C, Jawad-Ul-Qamar M, Kirchhof P, Rother J, Thomalla G, Veltkamp R, Laufs U, Nabavi DG, Heuschmann PU, Endres M, Haeusler KG. Extent of routine diagnostic cardiac work-up at certified German stroke units participating in the prospective MonDAFIS study. Neurol Res Pract. 2023 Jun 1;5(1):21. doi: 10.1186/s42466-023-00246-8.

    PMID: 37259147DERIVED

  • Olma MC, Tutuncu S, Fiessler C, Kunze C, Kramer M, Steindorf-Sabath L, Jawad-Ul-Qamar M, Kirchhof P, Laufs U, Schurig J, Kraft P, Rother J, Gunther A, Thomalla G, Dimitrijeski B, Nabavi DG, Veltkamp R, Heuschmann PU, Haeusler KG, Endres M; MonDAFIS Investigators [Link]. In-Hospital ECG Findings, Changes in Medical Management, and Cardiovascular Outcomes in Patients With Acute Stroke or Transient Ischemic Attack. J Am Heart Assoc. 2023 Jan 17;12(2):e027149. doi: 10.1161/JAHA.122.027149. Epub 2023 Jan 11.

    PMID: 36628982DERIVED

  • Haeusler KG, Kirchhof P, Kunze C, Tutuncu S, Fiessler C, Malsch C, Olma MC, Jawad-Ul-Qamar M, Kramer M, Wachter R, Michalski D, Kraft A, Rizos T, Groschel K, Thomalla G, Nabavi DG, Rother J, Laufs U, Veltkamp R, Heuschmann PU, Endres M; MonDAFIS Investigators. Systematic monitoring for detection of atrial fibrillation in patients with acute ischaemic stroke (MonDAFIS): a randomised, open-label, multicentre study. Lancet Neurol. 2021 Jun;20(6):426-436. doi: 10.1016/S1474-4422(21)00067-3.

    PMID: 34022169DERIVED

  • Haeusler KG, Kirchhof P, Heuschmann PU, Laufs U, Busse O, Kunze C, Thomalla G, Nabavi DG, Rother J, Veltkamp R, Endres M. Impact of standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke (MonDAFIS): Rationale and design of a prospective randomized multicenter study. Am Heart J. 2016 Feb;172:19-25. doi: 10.1016/j.ahj.2015.10.010. Epub 2015 Oct 21.

    PMID: 26856211DERIVED

MeSH Terms

Conditions

StrokeAtrial Fibrillation

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Matthias Endres, MD

    Center for Stroke Research Berlin, Charité University Berlin, Campus Mitte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 30, 2014

Study Start

December 1, 2014

Primary Completion

May 1, 2020

Study Completion

October 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

DE(1)