Stroke-Card Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVASCage GmbH
About this trial
Stroke is the second leading cause of death and one of the main contributors to disability. Patients who survive the acute phase of ischemic stroke and those with transient ischemic attack (TIA) are at high risk of subsequent vascular events. Importantly, recurrent strokes are associated with a higher social and economic impact, higher case fatality, and worse clinical outcome than first-ever strokes. The burden of post-stroke complications, residual deficits, and inadequate medical and psychosocial care all contribute to long-term disability and reduced quality of life in these patients. The Department of Neurology of the Medical University Innsbruck 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. After implementation of STROKE-CARD care, the investigators aim to document the quality of post-stroke care and compare outcome parameters to historical cohorts and the change over time. Furthermore the investigators aim to gain a large data-resource for future research of biomarkers, disease mechanisms, prognosis and imaging mechanisms for R\&D.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with acute ischemic stroke or high-risk TIA (ABCD2-Score ≥ 4 points) treated at the Department of Neurology of each study center within 30 days after onset
Age ≥ 18 years
Written informed consent
Disqualifiers
Patients living outside the catchment area of the participating centers
Patients under law enforcement or within mandatory military service
Age < 18 years
Trial population
Patients with acute ischemic stroke or high-risk TIA (ABCD2-Score ≥ 4 points) in the last 30 days over 18 years of age will be invited to the study at all study centers in the designated departments.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
N/A - Observational Study
Other interventionN/A - Observational Study
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
CVD outcome
CVD outcome defined as nonfatal ischemic stroke, nonfatal hemorrhagic stroke, nonfatal myocardial infarction, or vascular death between hospital discharge and one year in an in-person follow-up and yearly for up to 6 years.
Time frame
1-7 years2
Health-related quality of life: scale
Self-reported health-related quality of life after one year in an in-person follow-up and yearly for up to 6 years using a telephone-based follow-up 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.
Time frame
1-7 yearsSecondary outcomes
1
Composite stroke event outcome
Composite outcome of ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA) (defined as transient neurological deficit \<24h and absence of diffusion-weighted imaging (DWI) positive lesions on MRI) after one year and on the long run
Time frame
1-7 years2
All-cause mortality
All-cause mortality after one year and in the long run
Time frame
1-7 years3
Individual 3-level components of the European Quality of Life 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire
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) after one year in an in-person follow-up and in the long run
Time frame
1-7 years4
Proportions of participants achieving target levels of risk factors
* systolic blood pressure \<140 mmHg and a diastolic blood pressure \<90 mmHg or a systolic blood pressure \<130 mmHg and a diastolic blood pressure \<85 mmHg at the study visit in patients with diabetes mellitus, severe renal impairment, or small-vessel disease at baseline, * achieving a glycated hemoglobin (HbA1c) concentration \<7.0% in patients with diabetes mellitus or \<8% in selected individuals * having quit smoking after one year and on the long run * being physically active for an average of \>90 minutes/week * taking lipid-lowering medication in all patients except those with an event of other determined etiology (e.g. due to vasculitis or vessel dissection) * achieving a low-density lipoprotein (LDL) cholesterol concentration \<70 mg/dL * taking anticoagulation or antiplatelet therapy in patients that had been prescribed such medication * taking anticoagulation in patients with atrial fibrillation after one year and in the long run
Time frame
1-7 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
VASCage GmbH
Lead sponsor
Medical University Innsbruck
Collaborator
St John of God Hospital, Vienna
Collaborator
Source ClinicalTrials.gov