Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-26 @ 5:08 PM
Study NCT ID:
NCT07076732
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2025-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet Indices and WBCs to MPV Ratio in Correlation With Angiographic Profiling of Myocardial Infarction With Non-Obstructive Coronary Arteries and Its Short-Term Outcomes
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-12', 'studyFirstSubmitDate': '2025-07-12', 'studyFirstSubmitQcDate': '2025-07-12', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'White blood cell count to mean platelet volume ratio (WMR)', 'timeFrame': 'Within 6 hours of symptom onset', 'description': 'White blood cell count to mean platelet volume ratio (WMR) will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Incidence of major adverse cardiovascular events', 'timeFrame': '1 month post-procedure', 'description': 'Incidence of major adverse cardiovascular events (MACE) will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platelet Indices', 'White Blood Cell', 'Mean Platelet Volume', 'Myocardial Infarction', 'Obstructive Coronary Arteries', 'Short-Term Outcomes']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the role of platelet indices and the \\[White blood cell (WBC) /mean platelet volume (MPV)\\] ratio in correlation with angiographic profiles of patients diagnosed with myocardial infarction with non-obstructive coronary arteries (MINOCA) to assess their predictive value for short-term clinical outcomes.', 'detailedDescription': 'Globally, ischemic heart disease remains a significant cause of death, and its prevalence constantly increases. Around 5-15% of acute myocardial infarction (AMI) patients show nonobstructive (\\<50% stenosis) coronary arteries, named myocardial infarction with nonobstructive coronary arteries (MINOCA).\n\nThere are two main phases of inflammation during myocardial infarction: the inflammatory phase and the proliferative phase. The white blood cell (WBC) count and its subtypes have been investigated as potential predictors of cardiovascular outcomes in patients with coronary artery disease (CAD), serving as inflammatory markers.\n\nThe mean platelet volume (MPV) is determined in the progenitor cell, the bone marrow megakaryocyte. The platelet volume is found to be associated with cytokines (thrombopoietin, interleukin-6, and interleukin-3) that regulate megakaryocyte ploidy and platelet number and result in the production of larger platelets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This case-control study will be performed at Sohag University Hospitals after approval from the institutional ethical committee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old.\n* Both sexes.\n* Patients with acute myocardial infarction (AMI). Myocardial infarction with nonobstructive coronary arteries (MINOCA) is diagnosed if a patient fulfilled the AMI criteria in the absence of obstructive coronary arteries (type I: \\<50% stenosis; or type II: no stenosis) as recommended by the recent American Heart Association statement that introduces an updated definition incorporating the 4th universal MI definition, which by agreement excludes Takotsubo syndrome and myocarditis from the eventual diagnosis of MINOCA.\n\nExclusion Criteria:\n\n* Previous history of MI or coronary revascularization (PCI or bypass surgery) with acute/chronic infection.\n* Autoimmune diseases.\n* Systemic inflammatory disease.\n* Patients on treatment therapy which critically affects inflammatory cell count.\n* Patients with malignancy.\n* Chronic kidney disease.\n* Severe liver disease.\n* Severe anemia.\n* Fever (\\>38°C).'}, 'identificationModule': {'nctId': 'NCT07076732', 'briefTitle': 'Platelet Indices and WBCs to MPV Ratio in Correlation With Angiographic Profiling of Myocardial Infarction With Non-Obstructive Coronary Arteries and Its Short-Term Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Platelet Indices and WBCs to MPV Ratio in Correlation With Angiographic Profiling of Myocardial Infarction With Non-Obstructive Coronary Arteries (MINOCA) and Its Short-Term Outcomes', 'orgStudyIdInfo': {'id': 'Soh-Med-25-1-1PD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Myocardial infarction with nonobstructive coronary arteries (MINOCA) patients', 'interventionNames': ['Other: Coronary Angiography', 'Other: SYNTAX Score']}, {'label': 'Control group', 'description': 'Healthy control individual.', 'interventionNames': ['Other: Coronary Angiography', 'Other: SYNTAX Score']}], 'interventions': [{'name': 'Coronary Angiography', 'type': 'OTHER', 'description': 'Coronary angiograms will be acquired digitally for quantification.', 'armGroupLabels': ['Control group', 'Study group']}, {'name': 'SYNTAX Score', 'type': 'OTHER', 'description': 'Upon retrieval of a version from http://www.syntaxscore.com, the anatomical SYNTAX score will be implemented to numerically evaluate the intricacy of coronary lesions.', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82511', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Cardiovascular, Faculty of Medicine, Sohag University, Sohag, Egypt.', 'investigatorFullName': 'Remon Saleh Adly', 'investigatorAffiliation': 'Sohag University'}}}}