Ischemic Stroke, TIA
Conditions
Keywords
ischemic stroke, secondary prevention, transient ischemic attack, disease management
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).
Interventions
None listed
Sponsors
VASCage GmbH
Tirol Kiniken GmbH
Barmherzige Brüder Vienna
Medical University Innsbruck
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion in the previous STROKE-CARD trial (NCT02156778) * Written informed consent
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| self-reported health-related quality of life | through study completion, an average of 4,5 years | 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. |
| The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic) | through study completion, an average of 4,5 years | Recurrent stroke |
| The composite CVD outcome: nonfatal myocardial infarction | through study completion, an average of 4,5 years | Major recurrent (post-discharge) cardiac event |
| The composite CVD outcome: vascular death | through study completion, an average of 4,5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The composite outcome of stroke/TIA | through study completion, an average of 4,5 years | TIA defined as transient neurological deficit \<24h and absence of DWI positive lesions on MRI |
| all-cause mortality | through study completion at long term follow up visit, an average of 4,5 years | death from all causes |
| EQ-ED-3L | through study completion at long term follow up visit, an average of 4,5 years | 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) |
| 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 | 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). |
Countries
Austria
Outcome results
None listed