Stroke Card Long-term Follow-Up

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Ischemic Stroke; TIA

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1020
    • Hospital St. John's of God
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medical University of Innsbruck, Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composite outcome of stroke/TIA	TIA defined as transient neurological deficit <24h and absence of DWI positive lesions on MRI	through study completion, an average of 4,5 years
all-cause mortality	death from all causes	through study completion at long term follow up visit, an average of 4,5 years
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)	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.	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).	through study completion at long term follow up visit, an average of 4,5 years

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Collaborators: VASCage GmbH; Tirol Kiniken GmbH; Barmherzige Brüder Vienna
• Investigators: Principal Investigator: 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

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2019
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ischemic stroke; secondary prevention; transient ischemic attack; disease management
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: SCFU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No