Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT04657133
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2020-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'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'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 452}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-16', 'studyFirstSubmitDate': '2020-12-01', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes of intracerebral hematoma volume', 'timeFrame': '0-7 days after enrollment.', 'description': 'Intracerebral hematoma volume (ml) is assessed by CT brain scan'}, {'measure': 'Changes of perihematomal edema volume', 'timeFrame': '0-7 days after enrollment.', 'description': 'Perihematomal edema volume (ml) is assessed by CT brain scan'}, {'measure': 'Ordinal Distribution of Scores on mRS at Day 90', 'timeFrame': '90 days', 'description': 'The overall ordinal distribution of scores on mRS at 90 days in all subjects of two groups will be determined.'}, {'measure': 'Ordinal Distribution of Scores on mRS at Day 180', 'timeFrame': '180 days', 'description': 'The overall ordinal distribution of scores on mRS at 180 days in all subjects of two groups will be determined.'}], 'primaryOutcomes': [{'measure': 'Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days', 'timeFrame': '0-90 days.', 'description': 'The mRS ranges from 0 to 6, with higher scores indicating worse outcome. The primary outcome measure is the mRS score, dichotomized to define favorable functional outcome as mRS 0-2 at 90 days.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With mRS Score 0-3 at 90 Days', 'timeFrame': '90 days', 'description': 'The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-3 at 90 days.'}, {'measure': 'Proportion of Patients With mRS Score 0-2 at 180 Days', 'timeFrame': '180 days', 'description': 'The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-2 at 180 days.'}, {'measure': 'Proportion of Patients With mRS Score 0-3 at 180 Days', 'timeFrame': '180 days', 'description': 'The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Another measure of efficacy is the mRS score, dichotomized to define good functional outcome as mRS 0-3 at 180 days.'}, {'measure': 'Number of Subjects Experiencing Serious Adverse Events', 'timeFrame': '90 days', 'description': 'Number of subjects experiencing Serious adverse events at any time from randomization through day 90'}, {'measure': 'Number of Subjects With Serious Adverse Events Within 7 Days', 'timeFrame': '7 days', 'description': 'Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Therapy', 'Neuroprotection'], 'conditions': ['Intracerebral Hemorrhage', 'Acute Stroke']}, 'referencesModule': {'references': [{'pmid': '33174815', 'type': 'BACKGROUND', 'citation': "Shoamanesh A, Patrice Lindsay M, Castellucci LA, Cayley A, Crowther M, de Wit K, English SW, Hoosein S, Huynh T, Kelly M, O'Kelly CJ, Teitelbaum J, Yip S, Dowlatshahi D, Smith EE, Foley N, Pikula A, Mountain A, Gubitz G, Gioia LC. Canadian stroke best practice recommendations: Management of Spontaneous Intracerebral Hemorrhage, 7th Edition Update 2020. Int J Stroke. 2021 Apr;16(3):321-341. doi: 10.1177/1747493020968424. Epub 2020 Nov 11."}, {'pmid': '26022637', 'type': 'BACKGROUND', 'citation': 'Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.'}, {'pmid': '33739197', 'type': 'BACKGROUND', 'citation': 'Zhao W, Jiang F, Li S, Liu G, Wu C, Wang Y, Ren C, Zhang J, Gu F, Zhang Q, Gao X, Gao Z, Song H, Ma Q, Ding Y, Ji X; RICH-1 Investigators. Safety and efficacy of remote ischemic conditioning for the treatment of intracerebral hemorrhage: A proof-of-concept randomized controlled trial. Int J Stroke. 2022 Apr;17(4):425-433. doi: 10.1177/17474930211006580. Epub 2021 Apr 7.'}]}, 'descriptionModule': {'briefSummary': "Intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged by chronic hypertension, amyloid angiopathy or other disease. Currently, ICH has been a devastating type of stroke that lacking effective therapy. Remote ischemic conditioning (RIC), a systematically protective strategy, has been found to have neuroprotective effects by in patients with ischemic stroke. In addition, animal studies show that RIC is safe in ICH model and it could accelerate the absorption of hematoma. In a previous clinical study (RICH-1), RIC have been found to be safe and well-tolerated in patients with ICH. Therefore, the investigators plan to undertake this study to further evaluate the safety and efficacy of RIC in patients with ICH.\n\nThe investigators hypothesize that treatment with RIC will accelerate the absorption of hematoma and improve patients' functional outcomes. Results of this study can potentially bring into account new means to improve the outcomes of ICH patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 80 years\n2. The diagnosis of supratentorial ICH is confirmed by brain CT scan\n3. Hematoma volume of 10 to 30 ml and Glasgow Coma Score (GCS)\\>8 at randomization.\n4. National Institutes of Health Stroke Scale (NIHSS)≥6 and ≤20 points at randomization.\n5. Randomization and starting treatment between 24 and 48 hours of symptom ictus.\n6. Signed and dated informed consent is obtained.\n\nExclusion Criteria:\n\n1. Planned surgical evacuation of ICH prior to administration of investigational intervention\n2. ICH concomitant with subarachnoid hemorrhage or intraventricular hemorrhage\n3. Suspected secondary ICH related to tumor, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis\n4. Patients with a pre-existing neurological deficit (mRS\\>1) or psychiatric disease that would confound the neurological or functional evaluations.\n5. Coagulopathy - defined as elevated aPTT or INR \\>1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban or apixaban), or low-molecular-weight heparin\n6. Severe renal disease (i.e., renal disorder requiring dialysis ) or eGFR \\<30ml/min/1.73m2\n7. Severe liver disorder, or ALT \\>3 times or bilirubin \\>2 times upper limit of normal\n8. Known severe hearing loss or cognitive impairment\n9. Known pregnancy, or positive pregnancy test, or breastfeeding\n10. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, noncompliance or any other cause\n11. Life expectancy of less than 90 days due to co-morbid conditions\n12. Concurrent participation in another research protocol for investigation of another experimental therapy\n13. Severe, sustained hypertension (Systolic blood pressure\\> 180 mmHg or diastolic blood pressure\\> 110 mmHg).\n14. Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.\n15. Any condition which, in the judgement of the investigator, might increase the risk to the patient.'}, 'identificationModule': {'nctId': 'NCT04657133', 'acronym': 'RICH-2', 'briefTitle': 'Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'The Safety and Efficacy of Remote Ischemic Conditioning for the Treatment of Intracerebral Hemorrhage: A Multicenter, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'RICH-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Subjects in the intervention group will receive remote ischemic conditioning and standard background medical treatment.', 'interventionNames': ['Device: Remote ischemic conditioning', 'Drug: Standard medication therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham group', 'description': 'Subjects in the placebo group will receive sham remote ischemic conditioning and standard background medical treatment alone.', 'interventionNames': ['Device: Sham remote ischemic conditioning', 'Drug: Standard medication therapy']}], 'interventions': [{'name': 'Remote ischemic conditioning', 'type': 'DEVICE', 'otherNames': ['RIC'], 'description': 'RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 7 days after enrollment.', 'armGroupLabels': ['Intervention group']}, {'name': 'Sham remote ischemic conditioning', 'type': 'DEVICE', 'otherNames': ['Sham RIC'], 'description': 'Sham RIC will be performed by the same electric autocontrol device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (30 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 7 days after enrollment.', 'armGroupLabels': ['Sham group']}, {'name': 'Standard medication therapy', 'type': 'DRUG', 'description': 'Standard medication therapy will be performed according to the national and international guidelines.', 'armGroupLabels': ['Intervention group', 'Sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Beijing Red Cross Emergency Rescue Center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijng', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Na Li, M.D.', 'role': 'CONTACT'}], 'facility': 'Beijing Renhe Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chengde', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiangtao Zhang', 'role': 'CONTACT'}], 'facility': 'Chengde Central Hospital', 'geoPoint': {'lat': 40.9519, 'lon': 117.95883}}, {'city': 'Hengshui', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinjing Gao', 'role': 'CONTACT'}], 'facility': "The Six People's Hospital of Hengshui", 'geoPoint': {'lat': 37.73908, 'lon': 115.68348}}, {'city': 'Nanyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongyao Ma', 'role': 'CONTACT'}], 'facility': 'Nanshi Hospital of Nanyang', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'city': 'Tongliao', 'state': 'Inner Mongolia', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yaoming Xu, M.D.', 'role': 'CONTACT'}], 'facility': 'Tongliao Municipal Hosptial', 'geoPoint': {'lat': 43.6125, 'lon': 122.26528}}, {'city': 'Changzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Song Yang, M.D.', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Changzhou", 'geoPoint': {'lat': 31.77359, 'lon': 119.95401}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Deqin Geng, MD', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '300350', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ming Wei, MD', 'role': 'CONTACT'}], 'facility': 'Tianjin Huanhu Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Jiaxing', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianguo Shen', 'role': 'CONTACT'}], 'facility': 'Jiaxing Second Hospital', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}, {'zip': '312000', 'city': 'Shaoxing', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuebin Yu, MD', 'role': 'CONTACT'}], 'facility': "Shaoxing People's Hospital", 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}, {'city': 'Zhuji', 'state': 'Zhejiang', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Zhuji People's Hospital of Zhejaing Province", 'geoPoint': {'lat': 29.71877, 'lon': 120.24233}}], 'centralContacts': [{'name': 'Xunming Ji, MD, PhD', 'role': 'CONTACT', 'email': 'jixm@ccmu.edu.cn', 'phone': '010-83199430'}, {'name': 'Wenbo Zhao, MD, PhD', 'role': 'CONTACT', 'email': 'zhaowb@xwh.ccmu.edu.cn', 'phone': '86-13120136877'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ji Xunming,MD,PhD', 'investigatorAffiliation': 'Capital Medical University'}}}}