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StrokeStroke CardNCT02156778

Post-Stroke Disease Management - Stroke Card

A study of Stroke and Ischemic Attack, Transient, run by Medical University Innsbruck at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients after ischemic stroke are at high risk of recurrent cardiovascular events and of developing post-stroke complications. There is a substantial gap between risk factor management in real life and that recommended by international guidelines. Read more about this study

Who is it for?
Ages 18 years and older
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,149 participants
Where
1 siteAustria
Study dates
3 Jan 2014to 15 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • Patients with acute ischemic stroke or high-risk TIA (ABCD2≥3)
  • Age ≥ 18 years
  • Written informed consent

Who cannot join

  • Patients living outside the hospital catchment area
  • Malignant or other severe disease with life-expectancy less than the expected duration of the trial
  • Drug addiction or severe alcohol abuse
  • Patients with persistent severe disability ad discharge (mRS=5) not suitable for rehabilitation (this group will have outcome and complication assessment by a telephone interview with the caregivers according to current standards)

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Department of Neurology, Medical University Innsbruck

    Innsbruck, Tyrol, 6020

Other trials in Austria

About this study

Official title: Multifaceted Intervention to Reduce Recurrent Cardiovascular Events and Improve Quality-of-Life After Ischemic Stroke and High-Risk Transient Ischemic Attack (TIA)

Patients after ischemic stroke are at high risk of recurrent cardiovascular events and of developing post-stroke complications. There is a substantial gap between risk factor management in real life and that recommended by international guidelines. Stroke Card is a multifaceted comprehensive post-stroke disease management program to detect and treat complications and optimize secondary prevention. The investigators hypothesize that, compared to standard care, Stroke Card will lead to an at least 33.3% risk reduction in recurrent cardiovascular events and improve health-related quality-of-life.

Read the detailed description

Stroke is the leading cause of disability and morbidity in the Western world and will extend its lead based on the continuous aging of European populations. Apart from persistent deficits, potentially avoidable medium- and long-term complications are significant contributors to post-stroke functional impairment and an appealing target for concerted interventions. Moreover, there is a substantial gap between risk factor management in real life and that recommended by international guidelines, resulting in a large number of avoidable recurring events.

Stroke Card is a prospective block-randomized open interventional trial with blinded outcome assessment comparing two standards of post-stroke patient care which both comply with the current state-of-the-art. Consecutive patients treated at the Department of Neurology of the University Hospital Innsbruck with ischemic stroke or high-risk TIA will be allocated to either standard care or extended standard care according to the Stroke Card concept and will be enrolled during the initial hospital stay. A second study center (Hospital St. John of God Vienna) is also enrolling patients. The program complies with the respective guidelines of the American Heart Association (AHA), focuses on patient empowerment, patient self-management education, routine reporting to the general practitioner (GP), evidence-based decision making, shared knowledge, and cooperation among physicians.

Whereas disease management programs typically rely on expert opinion, our initiative moves from a purely empirical approach to a highly structured, individualized and evidence-based procedure with an outcome and health economy analysis.

Generic objectives:

Early detection or prevention of post-stroke complications, estimation of the patient's demand for nursing services and support, guideline-conform secondary prevention with full achievement of target levels, lifestyle modifications and outcome assessment after 3 and 12 months, assessment of 12-Mo body functioning (impairment), activity (disability) and participation (handicap and quality-of-life (QoL)).

Detailed assessment of patient adherence to drug prescriptions as well as lifestyle modifications and analysis of its key determinants.

Implementation of a simple electronic tool for patients ("My Stroke Card") capable of storing data, displaying risk factor levels over time (graphs), giving feedback about target level achievement (red, orange, green), providing information (recommendations, self-administered patient training programmes, etc), and unraveling post-stroke complications (modified post-stroke checklist). The "My Stroke Card" is also available in print version for patients without personal computer (PC) access.

Scientific proof that extended standard care ameliorates functional outcome and patient wellbeing (QoL), and improves secondary prevention of stroke and other vascular sequels without raising costs.

Refinement of Stroke Card components in the case of success to end up with a condensed practicable approach for broad routine use, and identification of subgroups with the most pronounced benefit.

Being tested
Active Comparator: Extended Standard Care (Stroke Card), Active Comparator: Standard Care
Keywords
Post-Stroke Disease Management, Post-Stroke Complication, Risk Factor Control, Quality-of-Life
Medical subject headings
Stroke, Ischemic Attack, Transient

What participants receive

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

  • Active Comparator: Extended Standard Care (Stroke Card)Behavioural

    Standard Care plus

    extended training with access to weekly educational lectures (education of patients and relatives), implementation of "My Stroke Card" containing (a) an adopted version of the 'post-stroke checklist' (ascertainment of post-stroke complications), (b) self-administered internet-based tools for risk factor monitoring and reinforcement of target level achievement, and (c) information and educational materials.

    3-Mo outpatient appointment with standardized assessment of risk factors and screening for complications, health problems and residual deficits, estimation of the patient's demand for nursing services and support, guideline-conform secondary prevention with full achievement of target levels, assessment of patient adherence to drug prescriptions.

    6-Mo and 9-Mo visits on the discretion of the study team in case of medical needs.

    12-Mo clinical visit and outcome assessment.

  • Active Comparator: Standard CareBehavioural

    In-hospital training (education of patients, next of kin and caregivers on risk factor management and assessment, life style improvement, and compliance).

    Complimentary provision of a book / information material dealing with patient and caregiver relevant aspects of stroke care.

    Advise by a dietitian (general advise and individualized recommendations in patients with diabetes and obesity).

    Standardized information materials (e.g. for OAK or NOAK therapy). Support for smoking cessation and weight reduction if necessary or requested. Detailed medical reports (doctor's letter for the general practitioner and patient) at discharge containing target levels for risk factor management.

    AF detection at the Stroke Unit (1-5 day monitoring) and/or at the ward (24-hour ECG).

    12-Mo clinical visit and outcome assessment.

Study groups in NCT02156778
Study groupRoleWhat they receive
Extended Standard Care (Stroke Card)Active comparatorNot described
Receives: Behavioral: Active Comparator: Extended Standard Care (Stroke Card)
Standard CareActive comparatorNot described
Receives: Behavioral: Active Comparator: Standard Care

What is being measured

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

  1. Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death]

    Measured: one year

  2. Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score)

    Co-primary endpoint

    Measured: at one year

Secondary outcomes (5)
  1. Recurrent stroke (both ischemic and hemorrhagic) and TIA

    Measured: one year

  2. Death from all causes

    Measured: one year

  3. Functional outcome

    modified Rankin Scale (mRS) ≤2 and shift analysis

    Measured: at one year

  4. Quality-of-Life 5 individual dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety and depression)

    Measured: at one year

  5. Target level achievement in secondary prevention

    Blood pressure < 140/90 (<130/85 in selected patients with diabetes, renal impairment or small-vessel disease), Hba1c<7.5% in patients with diabetes mellitus at baseline, nicotine abstinence in patients that had been smokers at baseline, LDL cholesterol < 100 mg/dL or <70 mg/dL in high-risk patients (i.e. stroke or TIA due to large-artery atherosclerosis or small-vessel occlusion, other evidence of atherosclerotic vascular disease, baseline diabetes), metabolic Syndrome (NCEP-ATPIII): reduction of component number by 1, physical activity >90 minutes, platelet inhibitor or oral anticoagulation, oral anticoagulation (INR 2-3, Time in Therapeutic Range (TTR)>70%) in case of atrial fibrillation (AF), lipid-lowering medication except for non-atherosclerotic strokes (e.g. vessel dissection).

    Measured: at one year

Timeline

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

  1. First posted5 Jun 2014 (estimated)
  2. Study start3 Jan 2014
  3. Primary completion15 Jan 2019
  4. Study completion15 Jan 2019

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02156778
Sponsor's protocol ID
UN2013-0045
Other IDs
20131203-854
Acronym
Stroke Card
Status last verified
Apr 2019
First submitted
3 Jun 2014
Last updated
9 Apr 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Kaltseis K, Felicetti S, Dejakum B, Weber L, Labrecque S, Karisik A, Moelgg K, Boehme C, Toell T, Mayer-Suess L, Eller MT, Frank F, Schiefecker A, Kiechl S, Knoflach M, Broessner G; STROKE-CARD Study Group. Migraine in Young Stroke Patients-Better Outcomes Despite Distinct Risk Profiles: Insights From the STROKE-CARD-Study. Eur J Neurol. 2026 Aug;33(8):e70709. doi: 10.1111/ene.70709.

    PubMed 42559950
  • 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
  • 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
  • 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
  • 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

Questions about this trial

What is this clinical trial studying?

A study of Stroke and Ischemic Attack, Transient, run by Medical University Innsbruck at 1 site 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 4 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: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death] (time frame: one year). 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 NCT02156778, which also lists 5 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 9 Apr 2019.

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