Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-03-06 @ 7:41 PM
Study NCT ID:
NCT02772133
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating PRCP in STEMI Patients Undergoing Primary PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 275}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-31', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating PRCP level', 'timeFrame': '1 month'}, {'measure': 'Circulating PRCP activity', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Circulating Ang II level', 'timeFrame': '1 month'}, {'measure': 'Circulating Ang-(1-7) level', 'timeFrame': '1 month'}, {'measure': 'Circulating BK-(1-9) level', 'timeFrame': '1 month'}, {'measure': 'Circulating KBK-(1-9) level', 'timeFrame': '1 month'}]}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'Percutaneous Coronary Intervention', 'PRCP']}, 'descriptionModule': {'briefSummary': 'Purpose: The purpose of this study is to evaluate the impact of acute ST-segment elevation myocardial infarction (STEMI) and primary percutaneous coronary intervention (PCI) on circulating prolylcarboxypeptidase (PRCP) level and activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects, consecutive patients with unstable angina, and those undergoing primary PCI for STEMI', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;\n* Age ≥18 years;\n* Informed consent from subject or next of kin.\n\nExclusion Criteria:\n\n* Nonischaemic Cardiomyopathy;\n* Cardiac surgery planed in the 6 months;\n* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);\n* Renal or hepatic failure;\n* Malignancy, HIV, or central nervous system disorder;\n* Cardiopulmonary resuscitation \\>15 min and compromised level of consciousness;\n* Cardiogenic shock;\n* Current participation in any research study involving investigational drugs or devices;\n* No written consensus;\n* Previous myocardial infarction.'}, 'identificationModule': {'nctId': 'NCT02772133', 'briefTitle': 'Circulating PRCP in STEMI Patients Undergoing Primary PCI', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'orgStudyIdInfo': {'id': '2015GSF118133'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'STEMI patients', 'interventionNames': ['Procedure: Primary PCI']}, {'label': 'Healthy subjects'}, {'label': 'Unstable angina'}], 'interventions': [{'name': 'Primary PCI', 'type': 'PROCEDURE', 'armGroupLabels': ['STEMI patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qianfoshan Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong University Qilu Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Jinan Central Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250021', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Provincial Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Pan-Pan Hao', 'investigatorAffiliation': 'Qilu Hospital of Shandong University'}}}}