Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-16 @ 9:58 AM
Study NCT ID:
NCT03004820
Status:
COMPLETED
Last Update Posted:
2018-01-31
First Post:
2016-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients will receive remote ischemic conditioning'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2016-12-10', 'studyFirstSubmitQcDate': '2016-12-23', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months', 'timeFrame': 'within 1 months'}], 'primaryOutcomes': [{'measure': 'Recurrent rate of ischemic stroke/transient ischemic stroke', 'timeFrame': 'within 3 months'}], 'secondaryOutcomes': [{'measure': 'Treatment-Related Adverse Events', 'timeFrame': 'within 3 months', 'description': 'pain and tolerability, redness, bleeding, palpitation'}, {'measure': 'Compliance of remote ischemic conditioning', 'timeFrame': 'within 3 months', 'description': 'the proportion of patients fulfill the treatment'}, {'measure': 'Incidence rate of vascular events', 'timeFrame': 'within 3 months', 'description': 'hemorrhage stroke, myocardial infarction and vascular death'}, {'measure': 'Improvements in NIH Stroke Scale', 'timeFrame': 'within1, 3 months', 'description': 'improvements in NIH Stroke Scale in patients without recurrence or vascular events'}, {'measure': 'Improvements in modified Rankin Scale', 'timeFrame': 'within 1, 3 months', 'description': 'improvements in modified Rankin Scale Scale in patients without recurrence or vascular events'}, {'measure': 'Improvements in Barthel Scale', 'timeFrame': 'within 1,3 months', 'description': 'improvements in Barthel Scale in patients without recurrence or vascular events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minor Ischemic Stroke', 'Transient Ischemic Attack', 'Remote Ischemic Conditioning'], 'conditions': ['Transient Ischemic Attack', 'Non-disabling Stroke']}, 'referencesModule': {'references': [{'pmid': '29363651', 'type': 'DERIVED', 'citation': 'Liu SM, Zhao WL, Song HQ, Meng R, Li SJ, Ren CH, Ovbiagele B, Ji XM, Feng WW. Rationale and Study Design for a Single-Arm Phase IIa Study Investigating Feasibility of Preventing Ischemic Cerebrovascular Events in High-Risk Patients with Acute Non-disabling Ischemic Cerebrovascular Events Using Remote Ischemic Conditioning. Chin Med J (Engl). 2018 Feb 5;131(3):347-351. doi: 10.4103/0366-6999.223849.'}]}, 'descriptionModule': {'briefSummary': "This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.", 'detailedDescription': "This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eighteen years old or older of any gender or race;\n2. Diagnosed with a non-cardiogenic MIS/TIA within 14 days; MIS is defined by an ischemic stroke of score of 3 or less on the NIHSS at the time of inclusion, TIA is defined as neurologic deficit attributed to focal brain ischemia, with symptoms resolution within 24 h of symptom onset, Symptom onset is defined by the "last see normal" principle;\n3. Stable vital signs, normal cardiac, hepatic and renal functions;\n4. Able to consent by himself/herself or by legally authorized representative.\n\nExclusion Criteria:\n\n1. Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI;\n2. Modified Rankin Scale score \\> 2 at inclusion;\n3. Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional treatment for the current event;\n4. Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart failure et al.) ;\n5. Clear indication for anticoagulation therapy ( cardiac source of embolus);\n6. Hemorrhagic tendency of any reason （including but not limit to Hemostatic disorder, platelet count \\<100 × 109/L, history of drug-induced hepatic dysfunction）;\n7. Any hemorrhagic transformation;\n8. Gastrointestinal bleed or major surgery within 3 months of symptoms onset;\n9. Stroke or TIA induced by interventional therapy or surgery;\n10. Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease which may contraindicate RIC;\n11. Systolic blood pressure greater than 200 mmHg after medication;\n12. Planned revascularization (any angioplasty or vascular surgery) within the next 3 months ；\n13. Scheduled for surgery or interventional treatment requiring RIC cessation within next 3 months;\n14. Severe noncardiovascular comorbidity with life expectancy \\< 3 months;\n15. Pregnancy;\n16. Currently receiving an investigational drug or device by other studies.'}, 'identificationModule': {'nctId': 'NCT03004820', 'acronym': 'PICNIC-ONE', 'briefTitle': 'Prevention of Ischemic Conditions in Non-disabling Stroke/Transient Ischemic Attack With Remote Ischemic Conditioning', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study', 'orgStudyIdInfo': {'id': 'RICMIS/TIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Ischemic Conditioning', 'description': "RIC (remote ischemic conditioning) consists of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.", 'interventionNames': ['Device: Remote Ischemic Conditioning']}], 'interventions': [{'name': 'Remote Ischemic Conditioning', 'type': 'DEVICE', 'description': "RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.", 'armGroupLabels': ['Remote Ischemic Conditioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '570102', 'city': 'Haikou', 'state': 'Hainan', 'country': 'China', 'facility': 'First Affiliated Hospital of Hainan Medical University', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'city': 'Changde', 'state': 'Hunan', 'country': 'China', 'facility': "Taoyuan People's Hospital", 'geoPoint': {'lat': 29.03205, 'lon': 111.69844}}, {'zip': '257034', 'city': 'Dongying', 'state': 'Shandong', 'country': 'China', 'facility': 'Shengli Oilfield Center Hospital', 'geoPoint': {'lat': 37.46271, 'lon': 118.49165}}], 'overallOfficials': [{'name': 'Xunming Ji, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}, {'name': 'Wuwei Feng, MD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Chief Surgeon, Vice President', 'investigatorFullName': 'Ji Xunming', 'investigatorAffiliation': 'Capital Medical University'}}}}