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Completed

NCT Number: NCT04749251

IDEAL Blood Pressure Management 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University
  • Klinikum Kassel
  • Rigshospitalet, Denmark
  • Sahlgrenska University Hospital
  • University Hospital Heidelberg

Registry information

Official study 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

Acronym: IDEAL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2021
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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