Journal Article

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

Schoenherr, Gudrun, Kiechl, Stefan, Rumpold, Gerhard, Ferrari, Julia, Lang, Clemens, Mayer, Lukas, Prantl, Barbara, Boehme, Christian, Krebs, Stefan, Lang, Wilfried, Willeit, Karin, Knoflach, Michael, Willeit, Peter, Griesmacher, Andrea, Toell, Thomas, Willeit, Johann

2018

Overview

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).

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Austria / Blood pressure / Cardiovascular diseases / Cardiovascular Diseases - mortality / Cardiovascular Diseases - prevention & control / Care and treatment / Cerebral infarction / Cerebrovascular disease and stroke / Clinical trials / Disease management / Disease prevention / Empowerment / Fatalities / Female / Health aspects / Hospitals / Humans / Intervention / Ischemic Attack, Transient - therapy / Male / Medicine / Medicine & Public Health / Morbidity / Myocardial infarction / Myocardial Infarction - mortality / Myocardial Infarction - prevention & control / Neurochemistry / Neurology / Neurosurgery / Outcome Assessment, Health Care / Patients / Quality of Life / Retrospective Studies / Risk Factors / Secondary prevention / Secondary Prevention - methods / Stroke / Stroke - mortality / Stroke - therapy / Stroke patients / Study Protocol / Transient ischemic attack