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. 2022 Aug 1;22(1):347.
doi: 10.1186/s12872-022-02785-5.

Long-term outcome of a 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

Christian Boehme #  1 , Lena Domig #  1   2 , Silvia Komarek  1   2 , Thomas Toell  1 , Lukas Mayer  1 , Benjamin Dejakum  1   2 , Stefan Krebs  3 , Raimund Pechlaner  1 , Alexandra Bernegger  3 , Christoph Mueller  1 , Gerhard Rumpold  4 , Andrea Griesmacher  5 , Marion Vigl  3 , Gudrun Schoenherr  1 , Christoph Schmidauer  1 , Julia Ferrari  3 , Wilfried Lang  3   6 , Michael Knoflach  1 , Stefan Kiechl  7
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Long-term outcome of a 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

Christian Boehme et al. BMC Cardiovasc Disord. .

Abstract

Background: Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of incident cardiovascular events and recurrent stroke. 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. We conducted the STROKE-CARD trial (NCT02156778), a multifaceted pragmatic disease management program between 2014 and 2018 with follow-up until 2019. This program successfully reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischaemic stroke or TIA within 12 months after the index event. To investigate potential long-term effects of STROKE-CARD care compared to standard care, an extension of follow-up is warranted.

Methods: We aim to include all patients from the STROKE-CARD trial (n = 2149) for long-term follow-up between 2019 and 2021 with the study visit scheduled 3-6 years after the stroke/TIA event. The co-primary endpoint is the composite of major recurrent cardiovascular events (nonfatal stroke, nonfatal myocardial infarction, and vascular death) from hospital discharge until the long-term follow-up visit and health-related quality of life measured with the European Quality of Life-5 Dimensions (EQ-5D-3L) at the final visit. Secondary endpoints include overall mortality, long-term functional outcome, and target-level achievement in risk factor management.

Discussion: This long-term follow-up will provide evidence on whether the pragmatic post-stroke/TIA intervention program STROKE-CARD is capable of preventing recurrent cardiovascular events and improving quality-of-life in the long run. Trial registration clinicaltrials.gov: NCT04205006 on 19 December 2019.

Keywords: Disease management program; Ischaemic stroke; Stroke long-term follow-up; Stroke secondary prevention; Transient ischaemic attack.

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Conflict of interest statement

The authors declare that they have no competing interests.

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