IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke

NCT04749251 | Completed

• 1 other identifier: IDEAL BP Feasibility Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Endovascular therapy; Blood pressure; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Recruitment rate (percentage)

  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

  Assessed 3 months after endovascular treatment

• Data completeness (percentage)

  Assessed up to 3 months after endovascular treatment

• Degree of reperfusion

  Assessed up to 3 months after endovascular treatment

Other Outcomes (1)

• Criteria for continuation to the definitive trial

  Assessed up to 3 months after endovascular treatment

Study Arms (2)

Individual blood pressure management arm

EXPERIMENTAL

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

Standard blood pressure management arm

ACTIVE COMPARATOR

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

Interventions

Individualized blood pressure management PROCEDURE

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

Individual blood pressure management arm

Standard blood pressure management PROCEDURE

During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg

Standard blood pressure management arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aalborg University: collaborator
• Klinikum Kassel: collaborator
• University Hospital Heidelberg: collaborator
• Sahlgrenska University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mads Rasmussen, MD, PhD

  Department of Anesthesia, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 11, 2021
• Study Start: April 1, 2021
• Primary Completion: January 16, 2022
• Study Completion: January 16, 2022
• Last Updated: June 13, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data may be shared after publication of main study results within a period of 5 years after publication
• Access Criteria: No criteria

Locations

DK (1)