Acute Ischemic Stroke
Conditions
Keywords
Mechanical thrombectomy, Blood pressure management
Brief summary
CRISIS I is a prospective, multicenter, randomized controlled trial, to asses the impact of intensive blood pressure control on clinical outcome of acute ischemic stroke patients with successful recanalization after endovascular therapy.
Detailed description
CRISIS I aims to determine the effectiveness of more intensive BP lowering target (\<120 mmHg) compared to standard BP management target (\<140mmHg) on functional outcome in patients with successful recanalization post-MT for AIS due to anterior circulation large vessel occlusion (LVO).
Interventions
The aim is to achieve a systolic BP level of \<120mmHg within 1hour after successful recanalization and to maintain this BP level for the next 72 hours (or until hospital discharge or death of this should occur earlier)
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Open intervention; outcome assessments undertaken by trained research staff who are kept blind to treatment allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Diagnosis of AIS with anterior circulation LVO confirmed by brain imaging * To receive MT \<24 hours after AIS onset according to local guidelines * Successful recanalization (TICI score ≥2b) after MT * Sustained systolic BP ≥140 mmHg (defined as 2 successive readings \<10 mins) within 60 minutes after recanalization * Provide written informed consent (or approved surrogate) * Perform CTA or MRI before endovascular therapy * Signed an approved informed consents
Exclusion criteria
* Significant pre-stroke disability (mRS scores 2-5) * Definite indication/contraindication to different intensities of BP lowering treatment * Specific contraindications to any of the BP agents to be used (eg, patients who are hypersensitive (allergic) to any of the ingredients) * Unlikely to potentially benefit from therapy (e.g. advanced dementia) or very high likelihood of death within 24 hours post-MT, judged by responsible treating clinician * Other medical illness that interferes with outcome assessments and follow-up (e.g.advance cancer and renal failure); Women who are lactating * Other conditions inappropriate for inclusion judged by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of disability | 90 days (3months) | a shift (improvement) in scores (0-6) on the modified Rankin scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intracerebral hemorrhage | 90 day | Any or symptomatic ICH (sICH) after endovascular therapy |
| Death or neurological severity | 7 days | Death or dependency measured by National Institutes of Health stroke scale (NIHSS) |
| BP lowering target (<120 mmHg) | 3 days | — |
Countries
China
Outcome results
None listed