Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-03 @ 7:07 PM
Study NCT ID:
NCT01609569
Status:
UNKNOWN
Last Update Posted:
2013-02-22
First Post:
2012-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pro-calcitonin Marker as Indicator of Ischemia in Patients With Complicated Coronary Intervention.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-20', 'studyFirstSubmitDate': '2012-05-29', 'studyFirstSubmitQcDate': '2012-05-31', 'lastUpdatePostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pro-calcitonin blood level', 'timeFrame': '"0,24 hours post cardiac intervention"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Disease']}, 'referencesModule': {'references': [{'pmid': '21378450', 'type': 'BACKGROUND', 'citation': 'Sinning CR, Sinning JM, Schulz A, Schnabel RB, Lubos E, Wild PS, Papassotiriou J, Bergmann A, Blankenberg S, Munzel T, Bickel C; AtheroGene Study Investigators. Association of serum procalcitonin with cardiovascular prognosis in coronary artery disease. Circ J. 2011;75(5):1184-91. doi: 10.1253/circj.cj-10-0638. Epub 2011 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine on preliminary basis weather an elevated pro-calcitonin level can be used to assess ischemia as a result of coronary artery complications during percutaneous coronary intervention (PCI).', 'detailedDescription': 'Pro-calcitonin is a type of protein found in the blood. This protein has recently be found to be elevated in patients with diseases of the arteries of the heart such as heart attack.\n\nPercutaneous coronary intervention (PCI) is widely used in the treatment of many patients with blockage in the arteries of the heart.\n\nthe investigators normally used a marker called troponin after cardiac catheterization. However, this marker may not be specific.\n\nPro-calcitonin has been found to be a useful marker for the detection of myocardial injury. the value of Pro-calcitonin as a marker for the identification of myocardial damage undergoing PCI has not yet been studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 18 years old.\n\nExclusion Criteria:\n\n* no consent.\n* suspicion of sepsis.\n* Patients with elevated troponin or procalcitonin before enrollment.\n* patients who had non-elective angioplasty (e.g. rescue angioplasty, primary angioplasty, salvage angioplasty, or emergency angioplasty)'}, 'identificationModule': {'nctId': 'NCT01609569', 'briefTitle': 'Pro-calcitonin Marker as Indicator of Ischemia in Patients With Complicated Coronary Intervention.', 'organization': {'class': 'OTHER', 'fullName': "Saint Michael's Medical Center"}, 'officialTitle': 'Utility of Pro-calcitonin as an Indicator of Ischemia in Patients Undergoing Percutaneous Coronary Intervention With Subsequent Coronary Complications.', 'orgStudyIdInfo': {'id': '#09/12'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary complication', 'description': 'patients with coronary complication and patients without coronary complications.\n\npro-calcitonin will be measured in both groups to see if any correlation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Michael's Medical Center", 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}], 'overallOfficials': [{'name': 'Habib Habib, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Saint Michael's Medical Center"}, {'name': 'Fayez Shamoon, MD,FACC', 'role': 'STUDY_DIRECTOR', 'affiliation': "Saint Michael's Medical Center"}, {'name': 'yaser elnhar, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Saint Michael's Medical Center"}, {'name': 'Vincent Debari, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Saint Michael's Medical Center"}, {'name': 'Ashraf Jmeian, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Saint Michael's Medical Center"}, {'name': 'Ahmad Isbitan, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Saint Michael's Medical Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Saint Michael's Medical Center", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Habib Habib, MD', 'investigatorAffiliation': "Saint Michael's Medical Center"}}}}