Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocol
Abstract Background Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of future cardiovascular events. Despite compelling evidence about the efficacy of secondary prevention, a substantial gap exists between risk factor management in real life and that recommended b...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-11-01
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| Series: | BMC Neurology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12883-018-1185-2 |
| _version_ | 1818061119748571136 |
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| author | Thomas Toell Christian Boehme Lukas Mayer Stefan Krebs Clemens Lang Karin Willeit Barbara Prantl Michael Knoflach Gerhard Rumpold Gudrun Schoenherr Andrea Griesmacher Peter Willeit Julia Ferrari Wilfried Lang Stefan Kiechl Johann Willeit |
| author_facet | Thomas Toell Christian Boehme Lukas Mayer Stefan Krebs Clemens Lang Karin Willeit Barbara Prantl Michael Knoflach Gerhard Rumpold Gudrun Schoenherr Andrea Griesmacher Peter Willeit Julia Ferrari Wilfried Lang Stefan Kiechl Johann Willeit |
| author_sort | Thomas Toell |
| collection | DOAJ |
| description | Abstract Background Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of future cardiovascular events. Despite compelling evidence about the efficacy of secondary prevention, a substantial gap exists between risk factor management in real life and that recommended by international guidelines. Moreover, stroke is a leading cause of disability and morbidity which partly emerges from post-stroke complications. Methods/design We designed a block-randomised (2:1 ratio) open pragmatic trial [NCT02156778] with blinded outcome assessment comparing STROKE-CARD to usual post-stroke-patient care. STROKE-CARD is a multifaceted post-stroke disease management program with the objective of reducing recurrent cardiovascular events and improving quality of life in ischaemic stroke and TIA-patients. It combines intensified multi-domain secondary prevention, systematic detection and treatment of post-stroke complications, and patient self-empowerment. Enrolment of 2160 patients with acute ischaemic stroke or TIA (ABCD2-Score ≥ 3) is planned at two study centres in Austria. The co-primary efficacy endpoints are (i) the composite of major recurrent cardiovascular events (nonfatal stroke, nonfatal myocardial infarction, and vascular death) occurring within 12 months after the index event and (ii) one-year health-related quality-of-life measured with the European Quality of Life-5 Dimensions (EQ-5D-3 L) questionaire. Secondary endpoints include all-cause mortality, functional outcome, and target-level achievement in risk factor management. Discussion This trial will provide evidence on whether the pragmatic post-stroke intervention program STROKE-CARD can help prevent cardiovascular events and improve quality-of-life within the setting of a high-quality acute stroke care system. In case of success, STROKE-CARD may be implemented in daily clinical routine and serve as a model for other disease management initiatives. Trial registration ClinicalTrials.gov: NCT02156778. (June 5, 2014, retrospectively registered). |
| first_indexed | 2024-12-10T13:43:15Z |
| format | Article |
| id | doaj.art-57458bc02b6f4bed9f5b031c02fc40ce |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-12-10T13:43:15Z |
| publishDate | 2018-11-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-57458bc02b6f4bed9f5b031c02fc40ce2022-12-22T01:46:34ZengBMCBMC Neurology1471-23772018-11-0118111010.1186/s12883-018-1185-2Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocolThomas Toell0Christian Boehme1Lukas Mayer2Stefan Krebs3Clemens Lang4Karin Willeit5Barbara Prantl6Michael Knoflach7Gerhard Rumpold8Gudrun Schoenherr9Andrea Griesmacher10Peter Willeit11Julia Ferrari12Wilfried Lang13Stefan Kiechl14Johann Willeit15Department of Neurology, Medical University of InnsbruckDepartment of Neurology, Medical University of InnsbruckDepartment of Neurology, Medical University of InnsbruckDepartment of Neurology, Hospital St. John of GodDepartment of Neurology, Hospital St. John of GodDepartment of Neurology, Medical University of InnsbruckDepartment of Neurology, Medical University of InnsbruckDepartment of Neurology, Medical University of InnsbruckDepartment of Medical Psychology, Medical University of InnsbruckDepartment of Neurology, Medical University of InnsbruckCentral Institute of Medical and Chemical Laboratory Diagnostics, University Hospital of InnsbruckDepartment of Neurology, Medical University of InnsbruckDepartment of Neurology, Hospital St. John of GodDepartment of Neurology, Hospital St. John of GodDepartment of Neurology, Medical University of InnsbruckDepartment of Neurology, Medical University of InnsbruckAbstract Background Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of future cardiovascular events. Despite compelling evidence about the efficacy of secondary prevention, a substantial gap exists between risk factor management in real life and that recommended by international guidelines. Moreover, stroke is a leading cause of disability and morbidity which partly emerges from post-stroke complications. Methods/design We designed a block-randomised (2:1 ratio) open pragmatic trial [NCT02156778] with blinded outcome assessment comparing STROKE-CARD to usual post-stroke-patient care. STROKE-CARD is a multifaceted post-stroke disease management program with the objective of reducing recurrent cardiovascular events and improving quality of life in ischaemic stroke and TIA-patients. It combines intensified multi-domain secondary prevention, systematic detection and treatment of post-stroke complications, and patient self-empowerment. Enrolment of 2160 patients with acute ischaemic stroke or TIA (ABCD2-Score ≥ 3) is planned at two study centres in Austria. The co-primary efficacy endpoints are (i) the composite of major recurrent cardiovascular events (nonfatal stroke, nonfatal myocardial infarction, and vascular death) occurring within 12 months after the index event and (ii) one-year health-related quality-of-life measured with the European Quality of Life-5 Dimensions (EQ-5D-3 L) questionaire. Secondary endpoints include all-cause mortality, functional outcome, and target-level achievement in risk factor management. Discussion This trial will provide evidence on whether the pragmatic post-stroke intervention program STROKE-CARD can help prevent cardiovascular events and improve quality-of-life within the setting of a high-quality acute stroke care system. In case of success, STROKE-CARD may be implemented in daily clinical routine and serve as a model for other disease management initiatives. Trial registration ClinicalTrials.gov: NCT02156778. (June 5, 2014, retrospectively registered).http://link.springer.com/article/10.1186/s12883-018-1185-2StrokeTransient ischemic attackSecondary preventionDisease management |
| spellingShingle | Thomas Toell Christian Boehme Lukas Mayer Stefan Krebs Clemens Lang Karin Willeit Barbara Prantl Michael Knoflach Gerhard Rumpold Gudrun Schoenherr Andrea Griesmacher Peter Willeit Julia Ferrari Wilfried Lang Stefan Kiechl Johann Willeit Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocol BMC Neurology Stroke Transient ischemic attack Secondary prevention Disease management |
| title | Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocol |
| title_full | Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocol |
| title_fullStr | Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocol |
| title_full_unstemmed | Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocol |
| title_short | Pragmatic trial of multifaceted intervention (STROKE-CARD care) to reduce cardiovascular risk and improve quality-of-life after ischaemic stroke and transient ischaemic attack –study protocol |
| title_sort | pragmatic trial of multifaceted intervention stroke card care to reduce cardiovascular risk and improve quality of life after ischaemic stroke and transient ischaemic attack study protocol |
| topic | Stroke Transient ischemic attack Secondary prevention Disease management |
| url | http://link.springer.com/article/10.1186/s12883-018-1185-2 |
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