Stroke Card Long-term Follow-Up

Study Overview
=================
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).

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

Conditions
-----------------
Ischemic Stroke, TIA

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion in the previous STROKE-CARD trial (NCT02156778) Written informed consent Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| STROKE CARD Cohort<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ischemic stroke, secondary prevention, transient ischemic attack, disease management