Clinical trial NCT04205006: Stroke Card Long-term Follow-Up
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
TIA
Keywords: ischemic stroke
secondary prevention
transient ischemic attack
disease management
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: VASCage GmbH
name: Tirol Kiniken GmbH
name: Barmherzige Brüder Vienna
First posted: 2019-12-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: Inclusion Criteria:

* Inclusion in the previous STROKE-CARD trial (NCT02156778)
* Written informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic)
timeFrame: through study completion, an average of 4,5 years
measure: The composite CVD outcome: nonfatal myocardial infarction
timeFrame: through study completion, an average of 4,5 years
measure: The composite CVD outcome: vascular death
timeFrame: through study completion, an average of 4,5 years
measure: self-reported health-related quality of life
timeFrame: through study completion, an average of 4,5 years
Secondary outcomes:
measure: The composite outcome of stroke/TIA
timeFrame: through study completion, an average of 4,5 years
measure: all-cause mortality
timeFrame: through study completion at long term follow up visit, an average of 4,5 years
measure: EQ-ED-3L
timeFrame: through study completion at long term follow up visit, an average of 4,5 years
measure: Proportions of participants achieving target levels of risk factors in each trial arm of the previous STROKE-CARD trial.
timeFrame: through study completion at long term follow up visit, an average of 4,5 years
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, Department of Neurology
state: Tyrol
city: Vienna
country: Austria
facility: Hospital St. John's of God
Study officials:
affiliation: Medical University of Innsbruck, Austria, Department of Neurology
name: Stefan Kiechl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital St. John's of God, Vienna, Austria, Department of Neurology
name: Wilfried Lang, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.