Aarhus University Hospital
Aarhus, 8200, Denmark
NCT Number: NCT04749251
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aarhus, 8200, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg
Time frame: Assessed up to 3 months after endovascular treatment
Functional outcome measure
Time frame: Assessed up 3 months after endovascular treatment
Percentage of admitted patients scheduled for EVT who is enrolled in the study
Time frame: Assessed 3 months after endovascular treatment
...Percentage of time outside the blood pressure targets
Time frame: Assessed up to 3 months after endovascular treatment
Percentage of complete patient data study records
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)
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:
University of Aarhus
Other
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
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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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