Clinical trial NCT04749251: IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Endovascular therapy
Blood pressure
Anesthesia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: Klinikum Kassel
name: University Hospital Heidelberg
name: Sahlgrenska University Hospital
name: Rigshospitalet, Denmark
First posted: 2021-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death)
timeFrame: Assessed up to 3 months after endovascular treatment
Secondary outcomes:
measure: Recruitment rate (percentage)
timeFrame: Assessed up 3 months after endovascular treatment
measure: Adherence to mean arterial blood pressure targets. Specifically, to determine the percentage of time outside the target treatment range
timeFrame: Assessed 3 months after endovascular treatment
measure: Data completeness (percentage)
timeFrame: Assessed up to 3 months after endovascular treatment
measure: Degree of reperfusion
timeFrame: Assessed up to 3 months after endovascular treatment
Other outcomes:
measure: Criteria for continuation to the definitive trial
timeFrame: Assessed up to 3 months after endovascular treatment
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Department of Anesthesia, Aarhus University Hospital
name: Mads Rasmussen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: