IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke

Study Overview
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Brief Summary
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The ideal blood pressure management strategy during endovascular therapy (EVT) for acute ischemic stroke has not been defined. The aim of this pilot randomized clinical trial is to determine whether randomization to a standard versus individual blood pressure management strategy during the EVT procedure is feasible.

Detailed Description
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Acute ischemic stroke (AIS) is a leading cause of death and long-term disability in the Western world. Catheter-based removal of blood clots (endovascular therapy-EVT) is now the standard of care for AIS caused by large vessel occlusions in the brain. The level of blood pressure during the procedure appears to influence outcome. However, optimal blood pressure management strategy has not been determined. Current blood pressure management strategy during EVT typically aims to maintain blood pressure above or within predefined fixed targets and is based on observational data and expert consensus rather than on high-quality randomized evidence. Should blood pressure during removal of the occlusion be managed according to the patient's individual blood pressure level or according to predefined fixed blood pressure targets? The primary aim of this pilot trial is to determine whether randomization to a procedure strategy targeting a predefined mean arterial blood pressure (MABP) of 70-90 mmHg versus an individual strategy targeting ± 10 % of a MABP reference value is feasible. Secondary aims are to test recruitability and to detect challenges or obstacles that would call for changes in the study design.

Official Title
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IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke:A Feasibility Study of Randomisation to Individual vs. Fixed Blood Pressure Targets During Endovascular Therapy for Acute Ischemic Stroke

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Procedure: Individualized blood pressure management
* Procedure: Standard blood pressure management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Large vessel occlusion in anterior circulation in patients deemed treatable with EVT. Living independently (mRS < 2) before stroke. EVT procedure feasible within 24 hours of symptom onset. Exclusion Criteria: Contra-indication/allergy to contrast agents, vasopressor agents or anaesthetics. Pregnancy. Medical condition where blood pressure targeting will be problematic (aorta dissection, etc). Participation in another trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be performed as a single center study, conducted at Aarhus University Hospital, Denmark. In the randomization process patients are stratified according to NIHSS (0-17 or > 17) and age (18-65 or > 66)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual blood pressure management arm<br>During the EVT procedure(in general anesthesia), mean arterial blood pressure (MABP) during is targeted to remain within +/- 10 % of a reference value using vasoactive drugs and/or fluids | Procedure: Individualized blood pressure management<br>* During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within +/- 10 % of a reference value using vasoactive drugs and/or fluids<br>|
| Active Comparator: Standard blood pressure management arm<br>During the EVT procedure(in general anesthesia), mean arterial blood pressure (MABP) during is targeted to remain within a fixed range of 70-90 mmHg | Procedure: Standard blood pressure management<br>* During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death) | Functional outcome measure | Assessed up to 3 months after endovascular treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate (percentage) | Percentage of admitted patients scheduled for EVT who is enrolled in the study | Assessed up 3 months after endovascular treatment | 
| Adherence to mean arterial blood pressure targets. Specifically, to determine the percentage of time outside the target treatment range | ...Percentage of time outside the blood pressure targets | Assessed 3 months after endovascular treatment | 
| Data completeness (percentage) | Percentage of complete patient data study records | Assessed up to 3 months after endovascular treatment | 
| Degree of reperfusion | Thrombolysis in Cerebral Infarction Score (TICI) score. The TICI score is a grading scale for angiographic outcomes rankin from 0 (no perfusion) to 3(complete perfusion) | Assessed up to 3 months after endovascular treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovascular therapy, Blood pressure, Anesthesia