Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT02442856
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2015-05-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-invasive Measurement of Cerebral Dynamic Autoregulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmullen@pennmedicine.upenn.edu', 'phone': '215-662-3339', 'title': 'Michael Mullen', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration of study, which was approximately 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.262', 'groupId': 'OG000', 'lowerLimit': '0.170', 'upperLimit': '0.366'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1.5 hours', 'description': 'Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.', 'unitOfMeasure': 'per second', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '21 subjects consented, hemodynamic monitoring possible in 18. 1 subject did not tolerate,data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate cerebral blood flow(CBF) was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis'}, {'type': 'PRIMARY', 'title': 'dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.278', 'groupId': 'OG000', 'lowerLimit': '0.199', 'upperLimit': '0.300'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1.5 hours', 'description': 'Rate of Regulation, measured using diffuse correlation spectroscopy. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.', 'unitOfMeasure': 'per second', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '21 subjects in the study, but hemodynamic monitoring was only possible in 18. 1 subject did not tolerate, and data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate CBF was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Linear Relationship Between Rate of Regulation Measured Using TCD and Optics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1.5 hours', 'description': 'Linear relationship between Rate of Regulation measured using TCD and Optics, expressed as slope of linear fit', 'unitOfMeasure': 'slope', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'We will measure dynamic cerebral autoregulation (dCA) with both transcranial doppler (TCD) and diffuse correlation spectroscopy (DCS) during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-17', 'size': 266244, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-11-14T11:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-03', 'studyFirstSubmitDate': '2015-05-08', 'resultsFirstSubmitDate': '2019-09-30', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-14', 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Linear Relationship Between Rate of Regulation Measured Using TCD and Optics', 'timeFrame': '1.5 hours', 'description': 'Linear relationship between Rate of Regulation measured using TCD and Optics, expressed as slope of linear fit'}], 'primaryOutcomes': [{'measure': 'dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD', 'timeFrame': '1.5 hours', 'description': 'Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.'}, {'measure': 'dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical', 'timeFrame': '1.5 hours', 'description': 'Rate of Regulation, measured using diffuse correlation spectroscopy. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The overall objective of this study is to evaluate the use of diffuse correlation spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with vascular risk factors. Optical cerebral blood flow measurements will be correlated with changes in arterial blood pressure to assess how CBF is maintained in response to changes in ABP, and will be compared to transcranial doppler reference measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 50 years\n* Positive history of at least one of the following vascular disk factors: hypertension, diabetes, hyperlipidemia, coronary artery disease, atrial fibrillation, prior myocardial infarct, transient ischemic attack, or history of smoking\n\nExclusion Criteria:\n\n* Vascular risk factor subjects:\n\n 1. Pregnant women\n 2. Prisoners\n 3. Prior neurosurgical procedure or traumatic brain injury, including hemicraniectomy or other skull defect\n 4. Prior history of ischemic or hemorrhagic stroke\n 5. Prior lower extremity amputation\n 6. Peripheral vascular disease'}, 'identificationModule': {'nctId': 'NCT02442856', 'acronym': 'TOMCAT', 'briefTitle': 'Non-invasive Measurement of Cerebral Dynamic Autoregulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'orgStudyIdInfo': {'id': '821705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'We will measure dCA with both TCD and DCS during acute changes in mean arterial pressure using thigh cuff deflation techniques in vascular risk factor subjects. Measurements will be compared between TCD and DCS in order to validate DCS as a tool to measure dCA in this population.', 'interventionNames': ['Device: Thigh Cuff']}], 'interventions': [{'name': 'Thigh Cuff', 'type': 'DEVICE', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}