IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Procedure: Standard blood pressure management; Procedure: Individualized blood pressure management

• Registration Number: NCT04749251
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-11
• Study Start: 2021-04-01
• Primary Completion: 2022-01-16
• Study Completion: 2022-01-16
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard blood pressure management arm	Standard blood pressure management	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
Individual blood pressure management arm	Individualized blood pressure management	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Recruitment rate (percentage)	Assessed up 3 months after endovascular treatment	Percentage of admitted patients scheduled for EVT who is enrolled in the study
Adherence to mean arterial blood pressure targets. Specifically, to determine the percentage of time outside the target treatment range	Assessed 3 months after endovascular treatment	...Percentage of time outside the blood pressure targets
Data completeness (percentage)	Assessed up to 3 months after endovascular treatment	Percentage of complete patient data study records
Degree of reperfusion	Assessed up to 3 months after endovascular treatment	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)

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark