The aim of this study is to assess the long-term outcomes (up to 36 months) and costs of stroke after EVT treatment, including direct EVT and IVT followed by EVT.
ID
Source
Brief title
Condition
- Other condition
- Central nervous system vascular disorders
- Embolism and thrombosis
Synonym
Health condition
Beroerte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes are (1) the score on the modified Rankin Scale (mRS), as
functional outcome measure from 0 (no symptom) to 6 (death), at 18, 24, 30 or
36 months after AIS and (2) long-term evolution of stroke lesions through
acquisition of a 24-month (range 18 to 36 months) follow-up MRI scan.
Secondary outcome
The secondary outcomes include the quality of life, Barthel index, major
vascular events, and costs related to stroke, both medical costs and
productivity loss, at 18, 24, 30 or 36 months. In addition we aim to include
deep leaming reconstruction, in which common image describïng parameters such
peak signal to noise ratio (pSNR), structural similarity (SSIM) and sharpness
will be evaluated.
Background summary
Endovascular thrombectomy (EVT) improves early clinical outcomes in acute
ischemic stroke (AIS) patients. The MR CLEAN-NO IV trial has been conducted to
assess the effects of direct EVT compared with IVT followed by EVT in patients
with AIS caused by computed tomography angiography confirmed anterior
circulation occlusion in the Netherlands. However, long-term outcomes and costs
after direct EVT are lacking.
Study objective
The aim of this study is to assess the long-term outcomes (up to 36 months) and
costs of stroke after EVT treatment, including direct EVT and IVT followed by
EVT.
Study design
The multicenter prospective study will be performed to collect the long-term
outcomes of patients who participated in the MR CLEAN-NO IV trial between
January 2018 and October 2020. The first part of the study involves contacting
patients once by telephone to collect clinical outcomes at 18, 24, 30 or 36
months after stroke, depending on the moment of study enrollment in the MR
CLEAN-NO IV trial. At the same time, these patients will be invited to fill out
two questionnaires on medical consumption and productivity loss either via post
or email to collect cost data. The second part of the study will involve
long-term evolution of stroke lesions through acquisition of a 24-month (range
18 to 36 months) follow-up MRI scan.
Intervention
The intervention group will undergo immediate IAT using a stent retriever, as
recommended by the steering committee. The standard care group will receive IVT
0.9 mg/kg with a maximum dose of 90 mg in one hour, followed by IAT using a
stent retriever.
Study burden and risks
It is foreseen that no risks are associated with participation, as there are no
risks associated with questionnaires or assessment of MRI at 3T when regular
contraindications for MRI are followed.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN80619088 |
| CCMO | NL58320.078.17 |