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Ischemic StrokeSCRNCT04582825

Stroke-Card Registry

An observational study of Ischemic Stroke and Transient Ischemic Attack, run by VASCage GmbH at 2 sites in Austria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Transient Ischemic Attack
What is being tested?
N/A - Observational Study
How many people
5,000 participants
Where
2 sitesAustria
Study dates
9 Dec 2020to 31 Mar 2027
How long will I take part?
7 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Austria2 sites
  • Medical University Innsbruck

    Innsbruck, Tyrol, 6020

  • Hospital St. John of God

    Vienna, State of Vienna, 1020

Other trials in Austria

About this study

Official title: STROKE-CARD REGISTRY: Extension of Standard Care in Patients With Ischemic Stroke and Transient Ischemic Attack

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.

Read the detailed description

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 a transient ischemic attack (TIA) are at high risk of subsequent stroke. 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. Furthermore, effects on quality of life and long-term functional independence are particularly under-investigated.

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. The aim is to evaluate this program in a large multicenter cohort and to establish a biobank of stroke and TIA-patients for future research and development projects.

In brief, the pragmatic and easily implementable STROKE-CARD care program reduced cardiovascular risk and improved health-related quality of life and functional outcome in patients with acute ischemic stroke or TIA in a timeframe of 12 months after the index event. To investigate the effects of STROKE-CARD care on a large basis and over a longer period, an evaluation of approximately 5,000 patients is warranted.

Whereas disease management programs typically rely on expert opinion, the STROKE-CARD initiative moved from a purely empirical approach to a highly structured, individualized, and evidence-based procedure with professional outcome analysis. The STROKE-CARD concept will be implemented in clinical practice and can serve as a model for other disease management initiatives.

Acute and short-term management of stroke and TIA has improved tremendously over the past years with substantial advances in acute therapy, implementation of comprehensive pathways for stroke and TIA, and approval of novel highly effective preventive treatments. As a main unmet challenge in stroke medicine, strategies of long-term care have to be developed and rigorously tested in order to maintain improved short-term patient outcome in the long run.

STROKE-CARD care reduced the one-year cumulative absolute risk of CVD and ameliorated the patients' health-related quality of life at 12 months (EQ-5D-3L overall utility score, P<0.001). These findings were consistent in subgroups according to age, sex, and index event and were robust in the per-protocol analysis. Among pre-specified secondary outcomes assessed at 12 months, the investigators observed improvements in all individual dimensions of the EQ-5D-3L and in one-year functional outcome, that each met the multiplicity-adjusted threshold for statistical significance. Only a few previous trials of disease management programs in stroke and TIA patients have focused on recurrent CVD or quality of life as primary or secondary endpoints and none has considered long-term functional outcome after one year. The previous trial was limited to a 12-month follow-up in selected individuals and the sustainability of benefits of STROKE-CARD care in a large nationwide cohort over a longer follow-up period remains to be determined.

This study aims to detect post-stroke complications, to estimate the patient's demand for nursing services, and support guideline-compliant secondary prevention with full achievement of target levels, lifestyle modifications, and in-person outcome assessment at 3 and 12 months after the index-event, assessment of functional status (impairment), activity (disability), and participation (handicap and health-related quality of life). Additionally, yearly follow-up telephone interviews for cardiovascular outcome and health parameters will be conducted. In case of clinically indicated in-person follow-ups, the interviews will be done in person during the clinical visits. After the 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.

The main objective is to evaluate the Post-Stroke Disease Management program STROKE-CARD in a large multicenter cohort of stroke and TIA-patients and to establish a large clinical well-defined cohort. Furthermore, the investigators aim to gain a large data resource for future research of biomarkers, disease mechanisms, prognosis and imaging mechanisms for R\&D.

To document and monitor the quality of the Post-Stroke Disease Management program in different centers and compare outcomes to the historical cohort, as well as other published data. Furthermore, the investigators aim to constantly improve post-stroke care. This registry can facilitate to monitor and document the effect on the primary and secondary outcomes.

There will be no formal safety endpoints in this study. No experimental procedures will be applied to patients and most of the procedures done are within the clinical routine. Potential side effects of optimal secondary stroke prevention are recorded.

Being tested
N/A - Observational Study
Keywords
Stroke secondary prevention, Stroke Risk factors, Biobank, Post-stroke care, Registry
Medical subject headings
Ischemic Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N/A - Observational StudyOther

    N/A - Observational Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1-7 years

  2. 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.

    Measured: 1-7 years

Secondary outcomes (5)
  1. Composite stroke event outcome

    Composite outcome of ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) (defined as transient neurological deficit <24h and absence of diffusion-weighted imaging (DWI) positive lesions on MRI) after one year and on the long run

    Measured: 1-7 years

  2. All-cause mortality

    All-cause mortality after one year and in the long run

    Measured: 1-7 years

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

    Mobility, self-care, usual activities, no pain or discomfort, no anxiety or depression) comparing people reporting no problems (level 1) with those reporting problems (level 2 and 3) after one year in an in-person follow-up and in the long run

    Measured: 1-7 years

  4. Proportions of participants achieving target levels of risk factors

    • systolic blood pressure <140 mmHg and a diastolic blood pressure <90 mmHg or a systolic blood pressure <130 mmHg and a diastolic blood pressure <85 mmHg at the study visit in patients with diabetes mellitus, severe renal impairment, or small-vessel disease at baseline,
    • achieving a glycated hemoglobin (HbA1c) concentration <7.0% in patients with diabetes mellitus or <8% in selected individuals
    • having quit smoking after one year and on the long run
    • being physically active for an average of >90 minutes/week
    • taking lipid-lowering medication in all patients except those with an event of other determined etiology (e.g. due to vasculitis or vessel dissection)
    • achieving a low-density lipoprotein (LDL) cholesterol concentration <70 mg/dL
    • taking anticoagulation or antiplatelet therapy in patients that had been prescribed such medication
    • taking anticoagulation in patients with atrial fibrillation after one year and in the long run

    Measured: 1-7 years

  5. Functional outcome

    Good functional outcome defined as modified Rankin Scale25 (mRS) ≤2 after one year and in the long run

    Distribution across mRS categories after one year and in the long run ("shift analysis")

    Measured: 1-7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2020
  2. Study start9 Dec 2020
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
Target duration
7 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582825
Sponsor's protocol ID
VASC-E3-2020-04
Acronym
SCR
Status last verified
Aug 2026
First submitted
3 Oct 2020
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30400876
  • 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.

    PubMed 32954239
  • 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.

    PubMed 31672716
  • 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.

    PubMed 40391684
  • 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.

    PubMed 40180369
  • 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.

    PubMed 39342159
  • 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.

    PubMed 38134562

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Transient Ischemic Attack, run by VASCage GmbH at 2 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CVD outcome (time frame: 1-7 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04582825, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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