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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic)
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion in the previous STROKE-CARD trial (NCT02156778)
- •Written informed consent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The composite CVD outcome: nonfatal stroke (ischemic or hemorrhagic)
Time Frame: through study completion, an average of 4,5 years
Recurrent stroke
The composite CVD outcome: vascular death
Time Frame: 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.
The composite CVD outcome: nonfatal myocardial infarction
Time Frame: through study completion, an average of 4,5 years
Major recurrent (post-discharge) cardiac event
self-reported health-related quality of life
Time Frame: 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.
Secondary Outcomes
- all-cause mortality(through study completion at long term follow up visit, an average of 4,5 years)
- The composite outcome of stroke/TIA(through study completion, an average of 4,5 years)
- EQ-ED-3L(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.(through study completion at long term follow up visit, an average of 4,5 years)