IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— IDEAL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749251
• Other study ID #: IDEAL BP Feasibility Study
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: January 16, 2022

Study information

• Verified date: January 2021
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 16, 2022
• Est. primary completion date: January 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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
• 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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (6)

Lead Sponsor	Collaborator
University of Aarhus	Aalborg University, Klinikum Kassel, Rigshospitalet, Denmark, Sahlgrenska University Hospital, Sweden, University Hospital Heidelberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Recruitment rate (percentage)	Percentage of admitted patients scheduled for EVT who is enrolled in the study	Assessed up 3 months after endovascular treatment
Secondary	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
Secondary	Data completeness (percentage)	Percentage of complete patient data study records	Assessed up to 3 months after endovascular treatment
Secondary	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