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AzTrials

StrokeMonDAFISNCT02204267

Impact of Standardized MONitoring for Detection of Atrial Fibrillation in Ischemic Stroke

A study testing prolonged ECG monitoring and ECG in people with Stroke and Atrial Fibrillation, run by Charite University, Berlin, Germany at 1 site 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Atrial Fibrillation
What is being tested?
prolonged ECG monitoring and ECG
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,470 participants
Where
1 siteGermany
Study dates
Dec 2014to Oct 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité Universitaetsmedizin Berlin

    Berlin, 12203

Other trials in Germany

About this study

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.

Being tested
prolonged ECG monitoring, ECG
Keywords
Stroke, atrial fibrillation, ECG
Medical subject headings
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

    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)

  • ECGDevice

Study groups in NCT02204267
Study groupRoleWhat they receive
prolonged ECG monitoringExperimentalRegular stroke unit treatment and diagnostic procedures according to guidelines and additional prolonged ECG monitoring
Receives: Other: prolonged ECG monitoring; Device: ECG
no additional ECG recordingNo interventionRegular stroke unit treatment and diagnostic procedures according to guidelines

What is being measured

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

  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.

    Measured: 12 months

Secondary outcomes (1)

  1. Number of stroke patients with newly detected atrial fibrillation

    Number of stroke patients with newly detected atrial fibrillation using a standardized prolonged ECG monitoring compared to usual stroke unit diagnostic procedures alone.

    Measured: 7 days

Timeline

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

  1. First posted30 Jul 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionMay 2020
  4. Study completionOct 2020

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02204267
Sponsor's protocol ID
MonDAFIS
Other IDs
EA2/033/14
Acronym
MonDAFIS
Status last verified
Nov 2020
First submitted
29 Jul 2014
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 39791425

  • 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.

    PubMed 38619714

  • 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.

    PubMed 37794453

  • 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.

    PubMed 37259147

  • 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.

    PubMed 36628982

  • 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.

    PubMed 34022169

  • 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.

    PubMed 26856211

Questions about this trial

What is this clinical trial studying?

A study testing prolonged ECG monitoring and ECG in people with Stroke and Atrial Fibrillation, run by Charite University, Berlin, Germany at 1 site 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 6 inclusion and 8 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 patients on oral anticoagulation (NOAC or VKA) (time frame: 12 months). 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 NCT02204267, which also lists 7 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 13 Nov 2020.

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