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Ischemic StrokeNCT04205006

Stroke Card Long-term Follow-Up

An observational study of Ischemic Stroke and TIA, run by Medical University Innsbruck at 2 sites in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, TIA
How many people
1,000 participants
Where
2 sitesAustria
Study dates
16 Dec 2019to 1 Nov 2022
Phase
Observational
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

Study population: All patients from the STROKE-CARD trial (n=2149) will be contacted by phone or mail for possible enrolment in the study. The STROKE-CARD cohort included consecutive patients with acute ischaemic stroke or TIA (ABCD2-Score ≥ 3) admitted to one of the two study centres (Medical University of Innsbruck, Hospital St. John's of God Vienna) between 2014 and 2018.

Who may be able to join

  • Written informed consent

Who cannot join

  • none

Trial locations and contacts

2 sites in 1 country.

Austria2 sites

  • Medical University of Innsbruck, Department of Neurology

    Innsbruck, Tyrol, 6020

  • Hospital St. John's of God

    Vienna, 1020

Other trials in Austria

About this study

Official title: Long-term Outcome of a Pragmatic Trial of Multifaceted Intervention (STROKE-CARD Care) to Reduce Cardiovascular Risk and Improve Quality-of-life After Ischemic Stroke and Transient Ischemic Attack

We 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. To further investigate the long-term efficacy of STROKE-CARD care all participants of the original trial will be invited for a Long-term in Person follow-up (3 - 6 years).

Conditions
Ischemic Stroke, TIA
Keywords
ischemic stroke, secondary prevention, transient ischemic attack, disease management
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.

Study groups in NCT04205006
Study groupRoleWhat they receive
STROKE CARD CohortConsecutive patients treated at the Department of Neurology of the University Hospital Innsbruck with ischemic stroke or high-risk TIA between 2013 and 2018 and enrolled in the Stroke Card trial, (except for those who aborted the previous trial).

What is being measured

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

  1. The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic)

    Recurrent stroke

    Measured: through study completion, an average of 4,5 years

  2. The composite CVD outcome: nonfatal myocardial infarction

    Major recurrent (post-discharge) cardiac event

    Measured: through study completion, an average of 4,5 years

  3. The composite CVD outcome: vascular death

    death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, stroke, cardiovascular procedures, and death due to other CV causes.

    Measured: through study completion, an average of 4,5 years

  4. self-reported health-related quality of life

    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: through study completion, an average of 4,5 years

Secondary outcomes (4)

  1. The composite outcome of stroke/TIA

    TIA defined as transient neurological deficit <24h and absence of DWI positive lesions on MRI

    Measured: through study completion, an average of 4,5 years

  2. all-cause mortality

    death from all causes

    Measured: through study completion at long term follow up visit, an average of 4,5 years

  3. EQ-ED-3L

    individual 3-level components of the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire14 (i.e. 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)

    Measured: through study completion at long term follow up visit, an average of 4,5 years

  4. Proportions of participants achieving target levels of risk factors in each trial arm of the previous STROKE-CARD trial.

    Blood pressure <140/<90 mmHg or <130/<85 mmHg in patients with diabetes mellitus, severe renal impairment; HbA1c <7.5% at the study visit in patients with diabetes mellitus; having quit smoking by the study visit in patients that had been smokers at baseline in the STROKE-CARD trial; 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: through study completion at long term follow up visit, an average of 4,5 years

Timeline

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

  1. First posted19 Dec 2019
  2. Study start16 Dec 2019
  3. Primary completion1 Nov 2022 (estimated)
  4. Study completion1 Nov 2022 (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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04205006
Sponsor's protocol ID
SCFU
Status last verified
Apr 2022
First submitted
13 Dec 2019
Last updated
30 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • 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

  • 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

  • Boehme C, Domig L, Komarek S, Toell T, Mayer L, Dejakum B, Krebs S, Pechlaner R, Bernegger A, Mueller C, Rumpold G, Griesmacher A, Vigl M, Schoenherr G, Schmidauer C, Ferrari J, Lang W, Knoflach M, Kiechl S. 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. BMC Cardiovasc Disord. 2022 Aug 1;22(1):347. doi: 10.1186/s12872-022-02785-5.

    PubMed 35915405

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and TIA, run by Medical University Innsbruck 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Aug 2022. 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?

Results are not available in the source record.

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?

The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic) (time frame: through study completion, an average of 4,5 years). The study lists 4 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 NCT04205006, 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 30 Aug 2022.

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Stroke Card Long-term Follow-Up (NCT04205006) | AzTrials