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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prolonged ECG monitoring | Experimental | Prolonged ECG monitoring: 10-day Holter ECG at months 0, 3 and 6 |
|
| standard care | Other | Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prolonged ECG monitoring | Other | 10-day Holter ECG measurement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months after study start |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Cardiology and Pneumology, University Medical Center Goettingen | Göttingen | 37075 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28187920 | Background | 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. | |
| 25262252 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2014 | Apr 30, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| standard care |
| Other |
Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring). |
|
| 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. | 30 months after study start |
| 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. | 24 months after study start |
| 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. | 24 months after study start |
| number of cardiovascular deaths | 24 months after study start |
| number of cerebrovascular deaths | 24 months after study start |
| number of transient ischemic attacks | 24 months after study start |
| number of myocardial infarctions | 24 months after study start |
| number of bleeding complications | 24 months after study start |
| quality of life | 24 months after study start |
| 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. | 24 months after study start |
| costs | 24 months after study start |
| number of correct monitorings | To assess the feasibility of monitoring procedures. | 24 months after study start |
| Clinic and Policlinic for Neurology, University of Mainz |
| Mainz |
| 55131 |
| Germany |
| Dept. of Neurology, Nordwest-Hospital Sanderbusch | Sande | 26452 | Germany |
| Dept. of Neurology, HSK, Dr. Horst-Schmidt-Hospital | Wiesbaden | 65199 | Germany |
| Background |
| 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. |
| 41731623 | Derived | 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. |
| 33421630 | Derived | 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. |
| 31813354 | Derived | 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. |
| 31071137 | Derived | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |