Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-07 @ 10:19 PM
Study NCT ID:
NCT02308605
Status:
COMPLETED
Last Update Posted:
2016-04-20
First Post:
2014-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 217}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-19', 'studyFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To measure the change in purines and their variability in control patients from baseline to day 7', 'timeFrame': '24 hours - 7 days'}], 'primaryOutcomes': [{'measure': 'To measure the levels of purine in the blood in Stroke patients compared to non-stroke patients (Healthy controls)', 'timeFrame': '30 minutes down to 5 minutes'}], 'secondaryOutcomes': [{'measure': 'To identify ischaemic versus haemorrhagic strokes by combining purine measurements and CT scans', 'timeFrame': '24 hours to 7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SMARTCap'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '30859371', 'type': 'DERIVED', 'citation': 'Dale N, Tian F, Sagoo R, Phillips N, Imray C, Roffe C. Point-of-care measurements reveal release of purines into venous blood of stroke patients. Purinergic Signal. 2019 Jun;15(2):237-246. doi: 10.1007/s11302-019-09647-4. Epub 2019 Mar 12.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis is that a stroke causes release of purines from brain into blood and that this is a very early biomarker of brain ischaemia. The investigators propose a simple blood test of substances (the purines) that result from cellular metabolism and are produced in excess when brain cells are starved of oxygen and glucose (as occurs during a stroke).', 'detailedDescription': 'In this study, the investigators propose to use newly developed biosensor technology (SMARTCap) to directly address whether purines are indicators of real strokes, and can distinguish strokes from other conditions with similar symptoms, more rapidly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '320', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Stroke patients: Admitted to the Hyperacute Stroke Unit having a suspected stroke within 1 hour of admission. Important to note that not all these patients will have suffered a stroke\n2. Control participants: Relatives of patients admitted to the stroke treatment pathway, who are healthy and have no signs of cardiovascular illness\n3. Healthy volunteers\n\nExclusion Criteria:\n\n1. Stroke patients: Delay in admission exceeds the time window of 4 hours between stroke symptoms and admission\n2. Control participants: Obvious signs or history of cerebrovascular disease\n3. Unhealthy volunteers'}, 'identificationModule': {'nctId': 'NCT02308605', 'acronym': 'SMARTCAP', 'briefTitle': 'SMARTCap Stroke Study: A Field Deployable Blood Test for Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Coventry and Warwickshire NHS Trust'}, 'officialTitle': 'A Field Deployable Blood Test for Stroke, Capable of Detecting Brain Ischaemia From the Earliest Stages of Pathology', 'orgStudyIdInfo': {'id': 'CI126414 23 May 2014 V1'}, 'secondaryIdInfos': [{'id': 'NIHR', 'type': 'OTHER_GRANT', 'domain': 'll-LA-0313-20002'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected stroke patients and subset', 'description': 'Blood samples taken on admission and at 24 hours, MRI scan between 24 and 48 hours\n\nSubset: Blood samples repeated once per hour for six hours', 'interventionNames': ['Device: SMARTCap']}, {'label': 'Control participants (relatives)', 'description': 'To donate blood on two occasions, 24 hours apart, to draw comparison with stroke patients', 'interventionNames': ['Device: SMARTCap']}, {'label': 'Feeding control participants', 'description': 'To donate a baseline blood sample, eat a simple purine rich meal (meat sandwich), then donate 4 more blood samples at 10, 30, 60 and 120 minutes following the meal', 'interventionNames': ['Device: SMARTCap']}], 'interventions': [{'name': 'SMARTCap', 'type': 'DEVICE', 'description': 'The Sarissa Biomedical SMARTCap biosensor array. This is an array of biosensors and electrodes in a simple moulded device that will fit into a vacutainer blood tube and will enable the rapid measurement of purines in freshly drawn blood. Therefore, this is not an intervention as such as the device is an In-Vitro Diagnostic Medical Device.', 'armGroupLabels': ['Control participants (relatives)', 'Feeding control participants', 'Suspected stroke patients and subset']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospitals Coventry & Warwickshire NHS Trust', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'ST4 7QB', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'University of Keele', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Christopher HE Imray, MB BS FRCP PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Coventry & Warwickshire NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Coventry and Warwickshire NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Christopher Imray, Consultant Vascular Surgeon', 'investigatorFullName': 'Professor Christopher Imray', 'investigatorAffiliation': 'University Hospitals Coventry and Warwickshire NHS Trust'}}}}