Acute Ischemic StrokeIDEALNCT04749251
IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke
A study testing Individualized blood pressure management and Standard blood pressure management in people with Acute Ischemic Stroke, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Individualized blood pressure management and Standard blood pressure management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 16 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Individualized blood pressure management, Standard blood pressure management
- Keywords
- Endovascular therapy, Blood pressure, Anesthesia
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized blood pressure managementProcedure or surgery
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 managementProcedure or surgery
During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Standard blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death)
Functional outcome measure
Measured: Assessed up to 3 months after endovascular treatment
Secondary outcomes (4)
Recruitment rate (percentage)
Percentage of admitted patients scheduled for EVT who is enrolled in the study
Measured: 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
...Percentage of time outside the blood pressure targets
Measured: Assessed 3 months after endovascular treatment
Data completeness (percentage)
Percentage of complete patient data study records
Measured: Assessed up to 3 months after endovascular treatment
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)
Measured: Assessed up to 3 months after endovascular treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Apr 2021
- Primary completion16 Jan 2022
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, Klinikum Kassel, University Hospital Heidelberg, Sahlgrenska University Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Mads Rasmussen, MD, PhD, Principal investigator, Department of Anesthesia, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749251
- Sponsor's protocol ID
- IDEAL BP Feasibility Study
- Acronym
- IDEAL
- Status last verified
- Jan 2021
- First submitted
- 29 Jan 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is a pilot study and the data may be made available to other researchers upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04749251
- Acronym / sponsor ID
- IDEAL / IDEAL BP Feasibility Study
- Conditions
- Acute Ischemic Stroke
- Keywords
- Endovascular therapy, Blood pressure, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University, Klinikum Kassel, University Hospital Heidelberg, Sahlgrenska University Hospital, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 16 Jan 2022 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Individual blood pressure management arm | Experimental | Procedure: Individualized blood pressure managementDuring 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 |
| Standard blood pressure management arm | Active comparator | Procedure: Standard blood pressure managementDuring the EVT procedure(in general anesthesia), mean arterial blood pressure (MABP) during is targeted to remain within a fixed range of 70-90 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized blood pressure managementDuring the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within +/- 10 % of a reference value using vasoactive drugs and/or fluids | Procedure or surgery | Individual blood pressure management arm |
| Standard blood pressure managementDuring the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg | Procedure or surgery | Standard blood pressure management arm |
Primary outcome
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
4 secondary outcomes
Recruitment rate (percentage)
Time frame: 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
Time frame: Assessed 3 months after endovascular treatment
Data completeness (percentage)
Time frame: Assessed up to 3 months after endovascular treatment
Degree of reperfusion
Time frame: Assessed up to 3 months after endovascular treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: Yes. This is a pilot study and the data may be made available to other researchers upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mads Rasmussen, MD, PhD principal investigator
Department of Anesthesia, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized blood pressure management and Standard blood pressure management in people with Acute Ischemic Stroke, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.