Stroke Card Long-term Follow-Up

NCT04205006 | Unknown

• 1 other identifier: SCFU
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

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

  Recurrent stroke

  through study completion, an average of 4,5 years

• The composite CVD outcome: nonfatal myocardial infarction

  Major recurrent (post-discharge) cardiac event

  through study completion, an average of 4,5 years

• 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.

  through study completion, an average of 4,5 years

• 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.

  through study completion, an average of 4,5 years

Secondary Outcomes (4)

• The composite outcome of stroke/TIA

  through study completion, an average of 4,5 years

• all-cause mortality

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

• EQ-ED-3L

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

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

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

Study Arms (1)

STROKE CARD Cohort

Consecutive 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).

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

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.

You may qualify if:

• Written informed consent

You may not qualify if:

• none

Sponsors & Collaborators

• Medical University Innsbruck: lead
• VASCage GmbH: collaborator
• Tirol Kiniken GmbH: collaborator
• Barmherzige Brüder Vienna: collaborator

Study Sites (2)

Medical University of Innsbruck, Department of Neurology

Innsbruck, Tyrol, 6020, Austria

Location

Hospital St. John's of God

Vienna, 1020, Austria

Location

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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

• 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.

  PMID: 35915405 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and whole blood sample.

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, Prof. Dr.

  Medical University of Innsbruck, Austria, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Wilfried Lang, Prof. Dr.

  Hospital St. John's of God, Vienna, Austria, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 19, 2019
• Study Start: December 16, 2019
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)