ong-term follow-up MR CLEAN-NO IV: evaluation of long-term outcomes after acute ischemic stroke.
Recruiting
- Conditions
- Beroertebrain infarctionStroke1000796310014523
- Registration Number
- NL-OMON53154
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 487
Inclusion Criteria
All subjects enrolled in the MR CLEAN-NO IV trial.
For patients that are also invited for the follow-up MRI scan, the following
additional criteria apply:
- 24-hours follow-up MRI scan available.
- Patiënt is able to come to the Amsterdam UMC by themselves or supported by
family or friends.
Exclusion Criteria
Only for patients that are invited to the follow-up MRI scan the following
exclusion criteria apply:
- Default research screening associated with a MRI scan (see attachment 'vragen
testpersonen 3TMRI_NL')
- Patiënt who are mobility impaired, as the study requires them to travel to
the hospital.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcomes are (1) the score on the modified Rankin Scale (mRS), as<br /><br>functional outcome measure from 0 (no symptom) to 6 (death), at 18, 24, 30 or<br /><br>36 months after AIS and (2) long-term evolution of stroke lesions through<br /><br>acquisition of a 24-month (range 18 to 36 months) follow-up MRI scan.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcomes include the quality of life, Barthel index, major<br /><br>vascular events, and costs related to stroke, both medical costs and<br /><br>productivity loss, at 18, 24, 30 or 36 months. In addition we aim to include<br /><br>deep leaming reconstruction, in which common image describïng parameters such<br /><br>peak signal to noise ratio (pSNR), structural similarity (SSIM) and sharpness<br /><br>will be evaluated.</p><br>