Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-28 @ 11:09 AM
Study NCT ID:
NCT05686057
Status:
UNKNOWN
Last Update Posted:
2023-01-17
First Post:
2023-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-06', 'lastUpdatePostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sST2 biomarker level', 'timeFrame': '24 hours before intervention', 'description': 'baseline comparison between ischemic heart disease and non-ischemic heart disease-control groups'}, {'measure': 'sST2 biomarker level', 'timeFrame': '48 hours post percutanous coronary intervention', 'description': 'follow up of only ischemic heart disease groups of sST2 level changes after intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sST2 biomarker', 'Modified Gensini Score', 'Revascularization'], 'conditions': ['Myocardial Ischemia', 'Heart Failure', 'Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'The role of soluble circulating suppression of tumorigenicity 2 biomarker (sST2) in the ischemic heart disease patient is a debatable point. Therefore the aims of this study are to assess the plasma level of sST2 in ischemic heart disease patients versus non-ischemic ones, the acute changes in its level after percutaneous coronary intervention (PCI) and its relation to the severity of ischemia.', 'detailedDescription': 'A comparison of ischemic patients and non-ischemic controls will be done. The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group. Then a study ischemic group will be divided into three subgroups; subgroup-1: single vessel disease, subgroup-2: two vessels disease and subgroup-3: multivessels disease. On admission, there will be a significant difference between the group of acute/chronic coronary syndrome cases and controls as regard sST2 plasma level or not. Moreover, the differences between the three ischemic subgroups at the baseline ST2 level will be assessed. The plasma sST2 level after PCI and the correlation between the acute change in pot-PCI sST2 level and the severity of ischemia by Modified Gensini Score (MGS) will be evaluated. The final question that will be answered by this study does the rapid impact of PCI on sST2 level will be mainly related to the severity of ischemia rather than left ventricular function or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All middle-old aged patients with IHD risk factors and acute or chronic coronary syndrome manifestations will undergo all routine investigations at baseline and after 24-48 hours of PCI and the levels of sST2 will be assessed for relations to acute changes in left ventricular EF by using 2-dimensional transthoracic echocardiography (2D-TTE) and the degree of ischemia by using Modified Gensini score. At the same time, the level of sST2 in control group with normal all routine diagnostic investigations will be assessed.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patients aged 40 years or more and have the risk factors of ischemic heart disease (IHD) with coronary artery disease symptoms will be included.\n* For control subjects should be aged ≥ 40 years old with IHD risk factors including DM and HTN and without any symptoms or signs of cardiac ischemia.\n\nExclusion Criteria:\n\n* Any patient with heart failure (EF \\<50%), any patients with rhythm abnormalities including atrial fibrillation, obese patients, structural heart diseases, uncontrolled chronic diseases such as hypertension or diabetes mellitus, any pulmonary artery or parenchymal diseases up to respiratory failure, acute systemic infection or inflammation, and chronic/acute renal diseases.'}, 'identificationModule': {'nctId': 'NCT05686057', 'acronym': 'ST2', 'briefTitle': 'sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Cardiac Ischemia and Percutaneous Coronary Intervention on the Changes of sST2 Level', 'orgStudyIdInfo': {'id': 'SVU2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single vessel diseased patients', 'description': 'sST2 level will be withdrawn at the baseline and after successful PCI', 'interventionNames': ['Device: percutanous coronary angiography with stenting']}, {'label': '2 vessels diseased patients', 'description': 'sST2 level will be withdrawn at the baseline and after successful PCI', 'interventionNames': ['Device: percutanous coronary angiography with stenting']}, {'label': 'multivessels diseased patients', 'description': 'sST2 level will be withdrawn at the baseline and after successful PCI', 'interventionNames': ['Device: percutanous coronary angiography with stenting']}, {'label': 'non-ischemic control patients', 'description': 'sST2 level will be withdrawn at the baseline'}], 'interventions': [{'name': 'percutanous coronary angiography with stenting', 'type': 'DEVICE', 'description': "Revascularization will be done by percutanous intervention after assessment of coronary stenosis by diagnostic coronary angiography under local anaesthesia with fluoroscopic guidance in acute/chronic coronary syndrome cases. The severity of stenosis will be done by modified gensini score from angiogram. An sST2 ELIZA test will be done after withdrawal of the cases' samples.", 'armGroupLabels': ['2 vessels diseased patients', 'multivessels diseased patients', 'single vessel diseased patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83523', 'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Areej AA Alkhateeb, Msc', 'role': 'CONTACT', 'email': 'areejalkhateeb@med.svu.edu.eg', 'phone': '+201023858689'}, {'name': 'Areej AA Tammam Alkhateeb, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'South Valley University Hospital', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}, {'city': 'Qina', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Alkhateeb', 'role': 'CONTACT', 'email': 'areejalkhateeb@med.svu.edu.eg', 'phone': '+201023858689'}, {'name': 'Areej AA Tammam Alkhateeb, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'South Valley University', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Alkhateeb', 'role': 'CONTACT', 'email': 'areejalkhateeb@med.svu.edu.eg', 'phone': '+201023858689'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'collaborators': [{'name': 'South Valley University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Cardiology', 'investigatorFullName': 'Areej Ahmad Abdullah Tammam Alkhateeb', 'investigatorAffiliation': 'Assiut University'}}}}