Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-13 @ 3:37 AM
Study NCT ID:
NCT05508269
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2019-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetics of Ischemic Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Cardiac tissue specimens and blood specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2022-08-17', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genetic pathway of pathological progression from stable coronary artery disease to myocardial infarction and finally to ischaemic cardiomyopathy', 'timeFrame': '2 years', 'description': 'The expected results may explain novel genetic pathways of the clinical progression of asymptomatic structural cardiac disorder (Stable coronary artery disease) to typically symptomatic ischaemic cardiomyopathy. Gene expression profiling of seven genes in RNA of all cardiac specimens was measured using QPCR analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic Cardiomyopathy', 'qrt-pcr'], 'conditions': ['Ischemic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'Background:Ischemic heart disease is one of the heaviest health-related burdens worldwide.We aimed to identify the common hub mRNA and pathways that are involved in pathological progression of ischemic cardiomyopathy. Methods: To explore potential differentially expressed genes (DEGs) of all ischemic heart disease stages, we used chipster and GEO2R tools to analyze of retrieved eight high throughput RNA datasets obtained from GEO database. Gene Ontology functional annotation and Pathways enrichment analyses were used to obtain the common functional enriched DEGs which were visualized in protein-protein interactions (PPI) network to explore the hub mRNA according to the interaction scores. Validation qRT-PCR was carried out for blood and cardiac biopsies compared with controls to validate the determined four hub mRNAs and subsequently reviewed inside comprehensive published meta-analysis database. The validated mRNAs were visualized in two interaction modules. Finally screening of approved drugs was applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study subjects were categorized into three control cases who were diagonosed as healthy subjects after diagnostic catheterization, three patients with stable coronary artery disease undergoing elective PCI who were diagnozed with coronary lesion/s and underwent stent implantation without previous history of myocardial infarction, four patients with history of myocardial infarction or with acute myocardial infarction undergoing primary PCI and three patients with ischaemic cardiomyopathy diagnosed by ejection fraction less than 35% with history of coronary artery disease or myocardial infarction or those with acute myocardial infarction with reduced ejection fraction.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria The enrolled patients aged 20-80 years with stable coronary artery disease undergoing elective PCI or patients with unstable angina or myocardial infarction undergoing rescue PCI and admitted to the cardiology hospital (Asyut University, Asyut, Egypt) were recruited in this study.\n\nExclusion criteria Patients with dilated cardiomyopathy were execluded from this study.'}, 'identificationModule': {'nctId': 'NCT05508269', 'briefTitle': 'Genetics of Ischemic Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Quantitative Polymerase Chain Reaction of Four Genes in Coronary Artery Disease, Myocardial Infarction and Ischemic Cardiomyopathy', 'orgStudyIdInfo': {'id': 'RHFCS1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control subjects', 'description': 'control cases who were diagonosed as healthy subjects after diagnostic catheterization', 'interventionNames': ['Genetic: quantitative polymerase chain reaction(QPCR) for four genes', 'Procedure: Cardiac biopsy, blood sampling']}, {'label': 'Stable coronary artery disease', 'description': 'patients with stable coronary artery disease undergoing elective PCI who were diagnozed with coronary lesion/s and underwent stent implantation without previous history of myocardial infarction', 'interventionNames': ['Genetic: quantitative polymerase chain reaction(QPCR) for four genes', 'Procedure: Cardiac biopsy, blood sampling']}, {'label': 'Myocardial infarction patients', 'description': 'patients with history of myocardial infarction or with acute myocardial infarction undergoing primary PCI', 'interventionNames': ['Genetic: quantitative polymerase chain reaction(QPCR) for four genes', 'Procedure: Cardiac biopsy, blood sampling']}, {'label': 'Ischaemic cardiomyopathy patients', 'description': 'patients with ischaemic cardiomyopathy diagnosed by ejection fraction less than 35% with history of coronary artery disease or myocardial infarction or those with acute myocardial infarction with reduced ejection fraction.', 'interventionNames': ['Genetic: quantitative polymerase chain reaction(QPCR) for four genes', 'Procedure: Cardiac biopsy, blood sampling']}], 'interventions': [{'name': 'quantitative polymerase chain reaction(QPCR) for four genes', 'type': 'GENETIC', 'description': 'quantitative polymerase chain reaction(QPCR) for four genes', 'armGroupLabels': ['Control subjects', 'Ischaemic cardiomyopathy patients', 'Myocardial infarction patients', 'Stable coronary artery disease']}, {'name': 'Cardiac biopsy, blood sampling', 'type': 'PROCEDURE', 'description': 'In the studied thirteen peripheral blood subjects, five milliliters blood samples were taken from each patient in potassium EDTA tubes, immediately inserted in liquid nitrogen container and then stored in -80 refrigerators. All studied thirteen cardiac tissue subjects were underwent cardiac biopsy after PCI in order to take two specimens from the left ventricle using judkin right seven french catheters for femoral access and cardiac bioptome 2.3 mm wide. All cardiac specimens were collected in cryotubes, immediately inserted in liquid nitrogen container and then stored in -80 refrigerators.', 'armGroupLabels': ['Control subjects', 'Ischaemic cardiomyopathy patients', 'Myocardial infarction patients', 'Stable coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'cardiology hospital (Asyut University, Asyut, Egypt)', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Mina Wageh Mohareb, Clinical researcher, Faculty of Pharmacy, Cairo University', 'investigatorFullName': 'Mina Wageh Mohareb', 'investigatorAffiliation': 'Cairo University'}}}}