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 Type
OBSERVATIONAL
Enrollment
1,000
Medical University of Innsbruck, Department of Neurology
Innsbruck, Tyrol, Austria
Hospital St. John's of God
Vienna, Austria
The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic)
Recurrent stroke
Time frame: through study completion, an average of 4,5 years
The composite CVD outcome: nonfatal myocardial infarction
Major recurrent (post-discharge) cardiac event
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 4,5 years
The composite outcome of stroke/TIA
TIA defined as transient neurological deficit \<24h and absence of DWI positive lesions on MRI
Time frame: through study completion, an average of 4,5 years
all-cause mortality
death from all causes
Time frame: 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)
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Time frame: 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).
Time frame: through study completion at long term follow up visit, an average of 4,5 years