Stroke-Card Registry

NCT04582825 | Recruiting

• 1 other identifier: VASC-E3-2020-04
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

Brief Summary

Stroke is the second leading cause of death and one of the main contributors to disability. Patients who survive the acute phase of ischemic stroke and those with transient ischemic attack (TIA) are at high risk of subsequent vascular events. Importantly, recurrent strokes are associated with a higher social and economic impact, higher case fatality, and worse clinical outcome than first-ever strokes. The burden of post-stroke complications, residual deficits, and inadequate medical and psychosocial care all contribute to long-term disability and reduced quality of life in these patients. The Department of Neurology of the Medical University Innsbruck undertook the STROKE-CARD trial (NCT02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the Post-Stroke disease-management program STROKE-CARD care. After implementation of STROKE-CARD care, the investigators aim to document the quality of post-stroke care and compare outcome parameters to historical cohorts and the change over time. Furthermore the investigators aim to gain a large data-resource for future research of biomarkers, disease mechanisms, prognosis and imaging mechanisms for R\&D.

Conditions

Ischemic Stroke; Transient Ischemic Attack

Keywords

Stroke secondary prevention; Stroke Risk factors; Biobank; Post-stroke care; Registry

Outcome Measures

Primary Outcomes (2)

• CVD outcome

  CVD outcome defined as nonfatal ischemic stroke, nonfatal hemorrhagic stroke, nonfatal myocardial infarction, or vascular death between hospital discharge and one year in an in-person follow-up and yearly for up to 6 years.

  1-7 years

• Health-related quality of life: scale

  Self-reported health-related quality of life after one year in an in-person follow-up and yearly for up to 6 years using a telephone-based follow-up quantified with the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) overall health utility score14 with rescaled European visual analogue scale weights.

  1-7 years

Secondary Outcomes (5)

• Composite stroke event outcome

  1-7 years

• All-cause mortality

  1-7 years

• Individual 3-level components of the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire

  1-7 years

• Proportions of participants achieving target levels of risk factors

  1-7 years

• Functional outcome

  1-7 years

Interventions

N/A - Observational Study OTHER

N/A - Observational Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute ischemic stroke or high-risk TIA (ABCD2-Score ≥ 4 points) in the last 30 days over 18 years of age will be invited to the study at all study centers in the designated departments.

You may qualify if:

• Patients with acute ischemic stroke or high-risk TIA (ABCD2-Score ≥ 4 points) treated at the Department of Neurology of each study center within 30 days after onset
• Age ≥ 18 years
• Written informed consent

You may not qualify if:

• Patients living outside the catchment area of the participating centers
• Patients under law enforcement or within mandatory military service
• Age \< 18 years

Sponsors & Collaborators

• VASCage GmbH: lead
• Medical University Innsbruck: collaborator
• St John of God Hospital, Vienna: collaborator

Study Sites (2)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Hospital St. John of God

Vienna, Vienna, 1020, Austria

RECRUITING

Related Publications (7)

• Toell T, Boehme C, Mayer L, Krebs S, Lang C, Willeit K, Prantl B, Knoflach M, Rumpold G, Schoenherr G, Griesmacher A, Willeit P, Ferrari J, Lang W, Kiechl S, Willeit J. 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 Neurol. 2018 Nov 6;18(1):187. doi: 10.1186/s12883-018-1185-2.

  PMID: 30400876 BACKGROUND

• Willeit P, Toell T, Boehme C, Krebs S, Mayer L, Lang C, Seekircher L, Tschiderer L, Willeit K, Rumpold G, Schoenherr G, Griesmacher A, Ferrari J, Knoflach M, Lang W, Kiechl S, Willeit J; STROKE-CARD study group. STROKE-CARD care to prevent cardiovascular events and improve quality of life after acute ischaemic stroke or TIA: A randomised clinical trial. EClinicalMedicine. 2020 Jul 28;25:100476. doi: 10.1016/j.eclinm.2020.100476. eCollection 2020 Aug.

  PMID: 32954239 BACKGROUND

• Boehme C, Toell T, Mayer-Suess L, Domig L, Pechlaner R, Willeit K, Tschiderer L, Seekircher L, Willeit P, Griesmacher A, Knoflach M, Willeit J, Kiechl S. The dimension of preventable stroke in a large representative patient cohort. Neurology. 2019 Dec 3;93(23):e2121-e2132. doi: 10.1212/WNL.0000000000008573. Epub 2019 Oct 31.

  PMID: 31672716 BACKGROUND

• Karisik A, Dejakum B, Moelgg K, Granna J, Felicetti S, Pechlaner R, Mayer-Suess L, Toell T, Buergi L, Scherer L, Willeit K, Heidinger M, Lang C, Ferrari J, Krebs S, Kleyhons R, Resch H, Willeit J, Seekircher L, Tschiderer L, Willeit P, Sykora M, Schett G, Lang W, Knoflach M, Kiechl S, Boehme C. Incidence, characteristics, and consequences of fractures after acute ischemic stroke and TIA-A prospective cohort study. Int J Stroke. 2025 Oct;20(9):1141-1149. doi: 10.1177/17474930251345300. Epub 2025 May 20.

  PMID: 40391684 DERIVED

• Moelgg K, Karisik A, Dejakum B, Felicetti S, Boehme C, Mayer-Suess L, Toell T, Knoflach M, Kiechl S, Pechlaner R. Longitudinal dynamics of pulse wave velocity in the days after acute ischaemic stroke: prospective cohort study. BMJ Open. 2025 Apr 3;15(4):e089304. doi: 10.1136/bmjopen-2024-089304.

  PMID: 40180369 DERIVED

• Karisik A, Bader V, Moelgg K, Buergi L, Dejakum B, Komarek S, Eller MT, Toell T, Mayer-Suess L, Pechlaner R, Granna J, Sollereder S, Rossi S, Schoenherr G, Willeit J, Willeit P, Lang W, Kiechl S, Knoflach M, Boehme C; STROKE-CARD study group. Comorbidities associated with dysphagia after acute ischemic stroke. BMC Neurol. 2024 Sep 28;24(1):358. doi: 10.1186/s12883-024-03863-1.

  PMID: 39342159 DERIVED

• Komarek S, Dejakum B, Moelgg K, Boehme C, Karisik A, Toell T, Kiechl S, Knoflach M, Pechlaner R, Mayer-Suess L. No association between SARS-CoV-2 vaccination and ischaemic stroke or high-risk transient ischaemic attack. J Neurol Sci. 2024 Jan 15;456:120834. doi: 10.1016/j.jns.2023.120834. Epub 2023 Oct 11.

  PMID: 38134562 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be collected at baseline and the follow-up visits in the department. In addition to plasma (5 aliquots á 500 µL-1000 µL) and serum (5 aliquots á 500 µL per evaluation), a whole blood sample (2.7 mL) will be archived. Additionally samples of thrombi extracted by mechanical thrombectomy procedures will be collected for further projects

MeSH Terms

Conditions

Ischemic Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Stefan Kiechl, MD

  Medical University Innsbruck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Böhme, MD

CONTACT

+43 512 504; christian.boehme@i-med.ac.at

Ulrike Pachmann, MSc

CONTACT

+43 512 554435; ulrike.pachmann@vascage.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2020
• First Posted: October 12, 2020
• Study Start: December 9, 2020
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

AU (2)