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Long-term follow-up MR CLEAN-NO IV: evaluation of long-term outcomes after acute ischemic stroke.

Long-term follow-up MR CLEAN-NO IV: evaluation of long-term outcomes after acute ischemic stroke. - Long-term follow-up MR CLEAN-NO IV

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53154
Enrollment
350
Registered
2017-10-19
Start date
2018-01-24
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beroerte brain infarction Stroke

Interventions

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 i

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)