Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2026-03-15 @ 4:08 PM
Study NCT ID:
NCT05342233
Status:
RECRUITING
Last Update Posted:
2022-04-22
First Post:
2022-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2028-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2022-04-10', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'up to 5 years', 'description': 'Mortality during follow-up period'}, {'measure': 'Rate of symptom relief', 'timeFrame': 'up to 5 years', 'description': 'Rate of symptom relief during follow-up period'}], 'secondaryOutcomes': [{'measure': 'Reintervention rate', 'timeFrame': 'Follow-up period（ 5 years）', 'description': 'Reintervention related to SISMAD after treatments during follow-up period'}, {'measure': 'Recurrence rate', 'timeFrame': 'Follow-up period（5 years）', 'description': 'SISMAD Recurrence after treatments during follow-up period'}, {'measure': 'Disease-related complications', 'timeFrame': 'Follow-up period（5 years）', 'description': 'Disease-related complications after treatments during follow-up period'}, {'measure': 'Complete remodeling rate of superior mesenteric artery dissection', 'timeFrame': 'Follow-up period（5 years）', 'description': 'Complete remodeling rate of superior mesenteric artery dissection after receiving different treatments'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spontaneous Isolated Superior Mesenteric Artery Dissection']}, 'descriptionModule': {'briefSummary': 'Spontaneous isolated superior mesenteric artery dissection(SISMAD) is an increasingly diagnosed disease. However, prospective, multicenter studies that can provide evidence to support clinical decisions are very limited. This study aims to compare the therapeutic efficacy of conservative and endovascular treatment for SISMAD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptoms or history of isolated superior mesenteric artery dissection and confirmed by CTA.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 and above;\n2. Isolated superior mesenteric artery dissection with clear symptoms or history and confirmed by CTA\n3. Signed informed consent forms, willing to receive treatments\n\nExclusion Criteria:\n\n1. Symptoms are severe and patients need exploratory laparotomy;\n2. Patients with aortic dissection, iliac artery dissection, or autoimmune vasculitis;\n3. Patients with mental illness cannot cooperate subjectively;\n4. Patients who are allergic to contrast agents, or contraindicated to conservative treatment drugs, and cannot be treated with drugs;\n5. Pregnancy and breastfeeding women, or patients who have recent birth plans;\n6. Patients who are participating in other clinical projects;\n7. Patients are not suitable to participate in this study.'}, 'identificationModule': {'nctId': 'NCT05342233', 'briefTitle': 'Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Comparison of Conservative and Endovascular Treatment for Spontaneously Isolated Superior Mesenteric Artery Dissection: A Real-world, Multicenter, Observational Study', 'orgStudyIdInfo': {'id': 'ISMAD2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endovascular treatment Group', 'description': 'Patients receiving endovascular treatments'}, {'label': 'Conservative treatment Group', 'description': 'Patients receiving conservative treatments, including blood pressure control, bowel rest, antithrombotic therapy, nutrition treatment and pain management.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Wei', 'role': 'CONTACT', 'email': 'weiwangcsu@csu.edu.cn', 'phone': '13808482650'}], 'facility': 'Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Wang WEI, Ph.D.', 'role': 'CONTACT', 'email': 'weiwangcsu@csu.edu.cn', 'phone': '13808482650'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Medical Center of Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'Peking University Shenzhen Hospital', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Chengde Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Inner Mongolia Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'xueguanwaike', 'investigatorAffiliation': 'Xiangya Hospital of Central South University'}}}}