Acute Management and Outcomes after ischemic STroke in patients with known Atrial Fibrillation
Organizational Data
- DRKS-ID:
- DRKS00035815
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2025-01-03
- Last update in DRKS:
- 2025-07-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
MOST-AF
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
The aim of the MOST-AF registry is to establish a prospective German registry of acute ischemic stroke patients with known atrial fibrillation. The objectives of the registry are to describe the clinical characteristics of its target population; to document the practice of acute stroke management on German Stroke Units; and to record routine data on clinical trajectories and functional outcome.
Health condition or problem studied
- ICD-10-GM (translation):
- I63 - Cerebral infarction
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Acute stroke patients with known atrial fibrillation receive standard care. Data on acute management and past medical history is extracted from routine clinical notes. Data on 90-day outcomes is collected via a follow-up interview.
Endpoints
- Primary outcome:
- Functional outcome (modified Rankin Scale) after 3 months
- Secondary outcome:
- Symptomatic intracranial hemorrhage (mSITS-MOST) within 36 hours
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Cross-sectional study
- Study type non-interventional:
- Register study
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Hamburg-Eppendorf Hamburg
- University medical center Universitätsklinikum Leipzig Leipzig
- University medical center Charité Berlin Berlin
- Medical center Klinikum Lüneburg Lüneburg
- University medical center Universitätsklinikum Tübingen Tübingen
- University medical center Universitätsklinikum Heidelberg Heidelberg
- University medical center Universitätsklinikum Dresden Dresden
- University medical center Klinikum der Universität München München
- University medical center Universitätsmedizin Mainz Mainz
- University medical center Medizinische Hochschule Hannover Hannover
- University medical center TUM Universitätsklinikum München
- Medical center München Klinik Harlaching München
- Medical center Klinikum Darmstadt Darmstadt
- Medical center Sana Klinken Duisburg Duisburg
- Medical center St. Josef Krankenhaus Moers Moers
- Medical center St.-Katharinen-Hospital Frechen
- Medical center Nordwest-Krankenhaus Sanderbusch Sande
- Medical center Agaplesion Bethesda Krankenhaus Bergedorf Hamburg
- Medical center Klinikum Worms Worms
Recruitment period and number of participants
- Planned study start date:
- 2025-02-01
- Actual study start date:
- 2025-02-01
- Planned study completion date:
- 2028-01-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1200
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Clinical diagnosis of acute ischemic stroke Stroke symptom onset within 24 hours prior to presentation Known diagnosis of atrial fibrillation Treatment on a certified German Stroke Unit or Neuro-Intensive Care Unit
Exclusion Criteria
First diagnosis of atrial fibrillation in-hospital Participation in a randomized acute stroke trial with concealed treatment allocation
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Hamburg-EppendorfMartinistr. 5220251 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Hamburg-EppendorfDr. Dr. Eckhard SchlemmMartinistr. 5220251 HamburgGermany
- Telephone:
- +4915222898447
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Contact for Public Queries
- Address:
- Universitätsklinikum Hamburg-EppendorfDr. Dr. Eckhard SchlemmMartinistr. 5220251 HamburgGermany
- Telephone:
- +4915222898447
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Principal Investigator
- Address:
- Universitätsklinikum Hamburg-EppendorfDr. Dr. Eckhard SchlemmMartinistr. 5220251 HamburgGermany
- Telephone:
- +4915222898447
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Hamburg-EpendorfMartinistr. 5220251 HamburgGermany
- Telephone:
- +4915222898447
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uke.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Ärztekammer HamburgWeidestraße 122 b22083 HamburgGermany
- Telephone:
- +49-40-202299240
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aerztekammer-hamburg.org/ethikkommission.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2024-08-27
- Ethics committee number:
- 2024-101348-BO-ff
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-08-28
Other Address Ethics Committee
- Address:
- Ethik-Kommission bei der Ärztekammer Schleswig-HolsteinBismarckallee 8-1223795 Bad SegebergGermany
- Telephone:
- +49-4551-803433
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aeksh.de/wir-ueber-uns/ehrenamt/kommissionen/ethikkommissionen
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-11-27
Other Address Ethics Committee
- Address:
- Ethik-Kommission der Landesärztekammer ThüringenIm Semmicht 3307751 JenaGermany
- Telephone:
- +49-3641-614213
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.laek-thueringen.de/aerzte/ethikkommission/
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-12-04
Other Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer HessenHanauer Landstraße 15260314 Frankfurt am MainGermany
- Telephone:
- +49-69-97672209
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.laekh.de/fuer-aerztinnen-und-aerzte/rund-ums-recht/ethik-kommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2024-12-13
Other Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer NordrheinTersteegenstr. 940474 DüsseldorfGermany
- Telephone:
- +49-211-43022272
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aekno.de/aerztekammer/ethik-kommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2025-01-28
Other Address Ethics Committee
- Address:
- Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität GießenFrankfurter Straße 51-5335392 GießenGermany
- Telephone:
- +49-641-9942470
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-giessen.de/fbz/fb11/dekanat/ethikkommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2025-03-06
Other Address Ethics Committee
- Address:
- Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am MenschenBerliner Allee 2030175 HannoverGermany
- Telephone:
- +49-511-38023102
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aekn.de/aekn/kommissionen/ethikkommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- 2025-01-16
Other Address Ethics Committee
- Address:
- Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum TübingenGartenstr. 4772074 TübingenGermany
- Telephone:
- +49-7071-2977661
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-tuebingen.de/de/medizinische-fakultaet/ethikkommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2025-05-07
Other Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin, Universitätsklinikum der Goethe-UniversitätTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63013758
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de/ueber-uns/vorstand-des-universitaetsklinikums/dekan/ethikkommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- No approval required according to the EC
- Date of the vote:
- 2025-02-03
Other Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Rheinland-PfalzMittlere Bleiche 4055116 MainzGermany
- Telephone:
- +49-6131-288220
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.laek-rlp.de/ausschuesse-kommissionen/ethikkommission/
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2025-05-19
Further identification numbers
- Other WHO Primary Registry or Data Provider ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- We will share individual participant data that underly any results reports, after deidentification. We will make available data and the study protocol beginning 3 months and ending 5 years following article publication to researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to e.schlemm@uke.de.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publications/study results:
- No Entry
- Date of the first journal publication of results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry