Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT04749251
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2021-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-10', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-02-09', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Criteria for continuation to the definitive trial', 'timeFrame': 'Assessed up to 3 months after endovascular treatment', 'description': 'The two arms are distinguishable on 3-month mRS with a trend statistical significant p-value below 0.1 or all of the following:\n\n* Drop out rate is less than 10%\n* Data completion is above 90%\n* (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'}], 'primaryOutcomes': [{'measure': '3-month Modified Rankin Score (mRS). The mRS is a functional outcome score rankin from 0(best outcome) to 6 (death)', 'timeFrame': 'Assessed up to 3 months after endovascular treatment', 'description': 'Functional outcome measure'}], 'secondaryOutcomes': [{'measure': 'Recruitment rate (percentage)', 'timeFrame': 'Assessed up 3 months after endovascular treatment', 'description': 'Percentage of admitted patients scheduled for EVT who is enrolled in the study'}, {'measure': 'Adherence to mean arterial blood pressure targets. Specifically, to determine the percentage of time outside the target treatment range', 'timeFrame': 'Assessed 3 months after endovascular treatment', 'description': '...Percentage of time outside the blood pressure targets'}, {'measure': 'Data completeness (percentage)', 'timeFrame': 'Assessed up to 3 months after endovascular treatment', 'description': 'Percentage of complete patient data study records'}, {'measure': 'Degree of reperfusion', 'timeFrame': 'Assessed up to 3 months after endovascular treatment', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endovascular therapy', 'Blood pressure', 'Anesthesia'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Large vessel occlusion in anterior circulation in patients deemed treatable with EVT.\n* Living independently (mRS \\< 2) before stroke.\n* EVT procedure feasible within 24 hours of symptom onset.\n\nExclusion Criteria:\n\n* Contra-indication/allergy to contrast agents, vasopressor agents or anaesthetics.\n* Pregnancy.\n* Medical condition where blood pressure targeting will be problematic (aorta dissection, etc).\n* Participation in another trial.'}, 'identificationModule': {'nctId': 'NCT04749251', 'acronym': 'IDEAL', 'briefTitle': 'IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IDEAL BP Feasibility Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individual blood pressure management arm', 'description': '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', 'interventionNames': ['Procedure: Individualized blood pressure management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard blood pressure management arm', 'description': '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', 'interventionNames': ['Procedure: Standard blood pressure management']}], 'interventions': [{'name': 'Individualized blood pressure management', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Individual blood pressure management arm']}, {'name': 'Standard blood pressure management', 'type': 'PROCEDURE', 'description': 'During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg', 'armGroupLabels': ['Standard blood pressure management arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Mads Rasmussen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesia, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data may be shared after publication of main study results within a period of 5 years after publication', 'ipdSharing': 'YES', 'description': 'This is a pilot study and the data may be made available to other researchers upon request', 'accessCriteria': 'No criteria'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aalborg University', 'class': 'OTHER'}, {'name': 'Klinikum Kassel', 'class': 'OTHER'}, {'name': 'University Hospital Heidelberg', 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}