IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke (IDEAL)

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Procedure: Individualized blood pressure management; Procedure: Standard blood pressure management

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual blood pressure management arm; 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; 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
Active Comparator: Standard blood pressure management arm; 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; During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Criteria for continuation to the definitive trial	The two arms are distinguishable on 3-month mRS with a trend statistical significant p-value below 0.1 or all of the following: Drop out rate is less than 10%; Data completion is above 90%; (A cumulated duration of 10 minutes outside the MABP targets is allowed) Additional cumulated time outside the respective MABP target range is on average less than 8% of the duration of the intervention	Assessed up to 3 months after endovascular treatment

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Rigshospitalet, Denmark; Sahlgrenska University Hospital, Sweden; University Hospital Heidelberg; Aalborg University; Klinikum Kassel
• Investigators: Principal Investigator: Mads Rasmussen, MD, PhD, Department of Anesthesia, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): January 16, 2022
• Study Completion (Actual): January 16, 2022

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Blood pressure; Anesthesia; Endovascular therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: IDEAL BP Feasibility Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: This is a pilot study and the data may be made available to other researchers upon request
• IPD Sharing Time Frame: Data may be shared after publication of main study results within a period of 5 years after publication
• IPD Sharing Access Criteria: No criteria
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No