Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-31 @ 8:44 AM
Study NCT ID:
NCT06446895
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000088442', 'term': 'MINOCA'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017023', 'term': 'Coronary Angiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000792', 'term': 'Angiography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D006334', 'term': 'Heart Function Tests'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-05-31', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml)', 'timeFrame': 'At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.', 'description': 'Levels of interleukin-6 (pg/ml) and tumor necrosis factor-alpha (pg/ml) will be determined.'}, {'measure': 'Levels of endhotelial disfunction biomarkers', 'timeFrame': 'At three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.', 'description': 'Levels of asymmetric dimethylarginine will be determined'}, {'measure': 'Levels of high-sensitivity C-reactive protein (mg/L)', 'timeFrame': 't three time points: within the 24 hours from the onset of pain, on the 5th day of admission, and two months after MI.', 'description': 'Levels of high-sensitivity C-reactive protein (mg/L) will be determined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Infarction', 'MINOCA', 'Inflammation', 'Biomarkers', 'Endothelial Dysfunction']}, 'descriptionModule': {'briefSummary': 'Around 10% of patients with myocardial infarction (MI) present with nonobstructive coronary arteries (MINOCA) which pathophysiology is often uncertain. The aim of the study is to evaluate inflammation and endothelial dysfunction biomarkers in MINOCA patients during both acute and stable phases, comparing them with those with MI and obstructive coronary arteries (MICAD).', 'detailedDescription': 'Prospective observational study in patients with Myocardial Infarction (MI) divided into two groups: MI with obstructive coronary arteries (MICAD) and MI with non-obstructive coronary arteries (MINOCA). Levels of interleukin-6, tumor necrosis factor-alpha, high-sensitivity C- reactive protein, and asymmetric dimethylarginine will be determined at three time points: within the 24 hours from the onset of pain, discharge, and two months after MI. The association of biomarkers, normalized by peak troponin value, with the risk of MINOCA will be evaluated using logistic regression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years old admitted to our hospital with Myocardial Infarction and undergo a coronariography.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted with Myocardial Infarction and undergo a coronariography\n* Patients must sign informed consent.\n\nExclusion Criteria:\n\n* Patients who don´t sign informed consent'}, 'identificationModule': {'nctId': 'NCT06446895', 'acronym': 'IMACORN-INFLI', 'briefTitle': 'Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Getafe'}, 'officialTitle': 'Biomarkers of Inflammation and Endothelial Dysfunction in Patients With Myocardial Infarction With Non-obstructive Coronary Arteries', 'orgStudyIdInfo': {'id': 'IMACORN-INFLI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MICAD', 'description': 'Patients with Myocardial Infarction and Obstructive Coronary Arteries', 'interventionNames': ['Diagnostic Test: Coronariography']}, {'label': 'MINOCA', 'description': 'Patients with Myocardial Infarction and Non-obstructive Coronary Arteries', 'interventionNames': ['Diagnostic Test: Coronariography']}], 'interventions': [{'name': 'Coronariography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients were classified as MICAD or MINOCA by the presence or absence of an epicardial vessel with ≥50% stenosis after performing a coronariography.', 'armGroupLabels': ['MICAD', 'MINOCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28905', 'city': 'Getafe', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'MARIA JESUS ESPINOSA PASCUAL, MD', 'role': 'CONTACT', 'email': 'mariajesusespinosapascual@gmail.com', 'phone': '636581691'}, {'name': 'JOAQUIN ALONSO, PHD', 'role': 'CONTACT', 'email': 'joaquinjalonso@gmail.com', 'phone': '609208299'}], 'facility': 'Hospital Universitario de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}], 'centralContacts': [{'name': 'MARIA JESUS ESPINOSA, MD', 'role': 'CONTACT', 'email': 'mariajesusespinosapascual@gmail.com', 'phone': '636581691'}, {'name': 'JOAQUIN ALONSO, PHD', 'role': 'CONTACT', 'email': 'joaquinjalonso@gmail.com', 'phone': '609208299'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Getafe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist', 'investigatorFullName': 'maria jesus espinosa pascual', 'investigatorAffiliation': 'Hospital Universitario Getafe'}}}}