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

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ClinicalTrials.gov Identifier: NCT04749251
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : October 14, 2021
Sponsor:
Collaborators:
Aalborg University
Klinikum Kassel
University Hospital Heidelberg
Sahlgrenska University Hospital, Sweden
Rigshospitalet, Denmark
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Procedure: Individualized blood pressure management Procedure: Standard blood pressure management Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death) [ Time Frame: Assessed up to 3 months after endovascular treatment ]
    Functional outcome measure


Secondary Outcome Measures :
  1. Recruitment rate (percentage) [ Time Frame: Assessed up 3 months after endovascular treatment ]
    Percentage of admitted patients scheduled for EVT who is enrolled in the study

  2. Adherence to mean arterial blood pressure targets. Specifically, to determine the percentage of time outside the target treatment range [ Time Frame: Assessed 3 months after endovascular treatment ]
    ...Percentage of time outside the blood pressure targets

  3. Data completeness (percentage) [ Time Frame: Assessed up to 3 months after endovascular treatment ]
    Percentage of complete patient data study records

  4. Degree of reperfusion [ Time Frame: 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)


Other Outcome Measures:
  1. Criteria for continuation to the definitive trial [ Time Frame: Assessed up to 3 months after endovascular treatment ]

    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04749251


Contacts
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Contact: Mads Rasmussen, MD, PhD +4530566977 mads.rasmussen@vest.rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8200
Contact: Mads Rasmussen, MD, PhD    +4529265713    mads.rasmussen@vest.rm.dk   
Sponsors and Collaborators
University of Aarhus
Aalborg University
Klinikum Kassel
University Hospital Heidelberg
Sahlgrenska University Hospital, Sweden
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Mads Rasmussen, MD, PhD Department of Anesthesia, Aarhus University Hospital
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04749251    
Other Study ID Numbers: IDEAL BP Feasibility Study
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This is a pilot study and the data may be made available to other researchers upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Endovascular therapy
Blood pressure
Anesthesia
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis