Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-28 @ 10:49 AM
Study NCT ID:
NCT06277895
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VOCs in Patients With Acute Cardiogenic Chest Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-18', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-02-18', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline VOCs (aldehydes) levels in healthy population', 'timeFrame': 'Baseline', 'description': 'Baseline VOCs (aldehydes) levels in healthy population'}], 'secondaryOutcomes': [{'measure': 'MACE in patients with cardiogenic chest pain', 'timeFrame': 'From enrollment to the end of treatment at 30 days', 'description': 'the relationship between the different VOCs levels and 30-day MACE in patients with cardiogenic chest pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Acute Aortic Syndrome']}, 'descriptionModule': {'briefSummary': 'The goal of this observation study is to compare VOCs in cardiogenic chest pain population/health conditions, to answer：Establishment and promotion of the application system of emergency rapid detection of expiratory Volatile Organic Compounds (VOCs) in patients with acute cardiogenic chest pain\n\n1. VOCs levels were measured at baseline in healthy people, and markers of VOCs that could be used to identify acute cardiogenic chest pain were sought.\n2. The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nObservation group inclusion criteria:\n\n1. Over 18 years old, male or female;\n2. Patients with acute cardiogenic chest pain (see diagnostic criteria);\n3. Patient\\'s informed consent.\n\nInclusion criteria of healthy control group:\n\n1. Over 18 years old, male or female;\n2. Centerless cerebrovascular disease, lung disease, no abnormal liver and kidney function, no acute infection recently;\n3. Informed consent.\n\nExclusion Criteria:\n\n1. The patient had difficulty in collecting breath;\n2. Patients with terminal illness or receiving palliative care;\n3. Have participated in other clinical studies or consider it inappropriate to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06277895', 'briefTitle': 'VOCs in Patients With Acute Cardiogenic Chest Pain', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Application of Emergency Rapid Detection of Expiratory Volatile Organic Compounds (VOCs) in Patients With Acute Cardiogenic Chest Pain', 'orgStudyIdInfo': {'id': 'KYLL-202401-047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cardiogenic chest pain group', 'description': 'cardiogenic chest pain group/acute coronary syndrome', 'interventionNames': ['Diagnostic Test: VOCs']}, {'type': 'OTHER', 'label': 'normal group', 'description': 'Healthy population', 'interventionNames': ['Diagnostic Test: VOCs']}], 'interventions': [{'name': 'VOCs', 'type': 'DIAGNOSTIC_TEST', 'description': 'test the end-expiratory gas', 'armGroupLabels': ['cardiogenic chest pain group', 'normal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yuan bian', 'role': 'CONTACT', 'email': '15165110975@163.com', 'phone': '18560084775'}], 'facility': 'Qilu hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yuan Bian, Dr.', 'role': 'CONTACT', 'email': 'bianyuan@sdu.edu.cn', 'phone': '+8618560083065'}, {'name': 'Xiuting Yang, Dr.', 'role': 'CONTACT', 'email': 'yxt-1819@163.com', 'phone': '800-872-5327'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}