Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-18 @ 11:42 AM
Study NCT ID:
NCT05230966
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2022-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunometabolic Pattern of Intermittent Hypoxia During ST-segment Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015428', 'term': 'Myocardial Reperfusion Injury'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2022-01-28', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of the concentration and dynamics of troponin T (Trop T)', 'timeFrame': '24 hour', 'description': 'Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of cardiac myosin binding protein C (cMyBP-C)', 'timeFrame': '24 hour', 'description': 'Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of creatine kinase-MB (CK-MB)', 'timeFrame': '24 hour', 'description': 'Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of oxidation/mitochondrial parameter, hypoxia-induced factor 1 alpha (HIF 1α)', 'timeFrame': '24 hour', 'description': 'serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of metabolic parameter, glycine', 'timeFrame': '24 hour', 'description': 'Serum concentrations (μmol/l) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of metabolic parameter, kynurenine', 'timeFrame': '24 hour', 'description': 'Serum concentrations (μmol/l) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of metabolic parameter, succinate', 'timeFrame': '24 hour', 'description': 'Serum concentrations (μM) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of immunological parameter, interleukin 1 beta (IL-1 beta)', 'timeFrame': '24 hour', 'description': 'Serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of immunological parameter, transforming growth factor beta (TGF beta)', 'timeFrame': '24 hour', 'description': 'Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}, {'measure': 'Measurement of the concentration and dynamics of immunological parameter, monocyte chemoattraction protein 1 (MCP-1)', 'timeFrame': '24 hour', 'description': 'Serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.'}], 'secondaryOutcomes': [{'measure': 'The changes in serum values of immunometabolic parameters and creatine kinase-MB', 'timeFrame': '24 hour', 'description': 'The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with a degree of tissue damage creatine kinase-MB.'}, {'measure': 'The changes in serum values of immunometabolic parameters and troponin T', 'timeFrame': '24 hour', 'description': 'The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with a degree of tissue damage troponin T'}, {'measure': 'The changes in serum values of immunometabolic parameters and left heart ejection fraction', 'timeFrame': '7 day', 'description': 'The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with functional assessment of the heart muscle, ejection fraction (%).'}, {'measure': 'The changes in serum values of immunometabolic parameters in PCI groups and angina pectoris (AP) group', 'timeFrame': '24 hour', 'description': 'The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with the data of patients diagnosed with angina pectoris (AP).'}, {'measure': 'The changes in serum values of immunometabolic parameters in PCI groups and the group of healthy volunteers', 'timeFrame': '24 hour', 'description': 'The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with the group of healthy volunteers in whom the RIC method was used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocardial Ischemic-reperfusion Injury']}, 'referencesModule': {'references': [{'pmid': '23281415', 'type': 'BACKGROUND', 'citation': 'Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.'}, {'pmid': '23270554', 'type': 'BACKGROUND', 'citation': 'Hausenloy DJ. Cardioprotection techniques: preconditioning, postconditioning and remote conditioning (basic science). Curr Pharm Des. 2013;19(25):4544-63. doi: 10.2174/1381612811319250004.'}, {'pmid': '32509561', 'type': 'BACKGROUND', 'citation': 'Han X, Jeong MH, Won J, Kim Y, Kim MC, Sim DS, Hong YJ, Kim JH, Ahn Y. Impact of Previous Angina on Clinical Outcomes in ST-Elevation Myocardial Infarction Underwent Percutaneous Coronary Intervention. Chonnam Med J. 2020 May;56(2):136-143. doi: 10.4068/cmj.2020.56.2.136. Epub 2020 May 25.'}, {'pmid': '25593060', 'type': 'BACKGROUND', 'citation': 'Heusch G, Botker HE, Przyklenk K, Redington A, Yellon D. Remote ischemic conditioning. J Am Coll Cardiol. 2015 Jan 20;65(2):177-95. doi: 10.1016/j.jacc.2014.10.031.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to characterize the protective pattern of intermittent hypoxia, angina pectoris and remote ischemic conditioning, in reperfusion injury by determining and monitoring the plasma immunometabolic parameters of patients with STEMI. This could contribute to better understanding of this phenotypic pattern with translation into clinical practice.', 'detailedDescription': 'In acute myocardial infarction with ST segment elevation (STEMI), lethal reperfusion injury of the myocardium, caused by percutaneous coronary intervention (PCI), represents additional and irreversible damage due to ischemic heart muscle reperfusion that contributes to the final size of the infarct zone by up to 50%. The size of the infarcted area is the major determinant for the long-term prognosis and heart failure progression in patients with STEMI. Cardioprotection from ischemic - reperfusion myocardial injury (MIRI) can be regulated by its own innate physiological adaptive mechanisms like intermittent hypoxia achieved by the method of conditioning that includes short sublethal ischemic and reperfusion episodes.\n\nThe known natural clinical equivalent of intermittent hypoxia and the starting point in understanding the underlying mechanism is angina pectoris (AP).\n\nIntermittent hypoxia is a protective mechanism against heart ischemic-reperfusion injury with reduced tissue damage and consequently better outcome in patients with STEMI. For the purpose of this work, a cardioprotective pattern was defined that includes immunometabolic factors as parameters for assessing the state of intermittent hypoxia on which the success of the application of the method of remote ischemic conditioning (RIC) is based.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor group 1:\n\n1. Acute coronary syndrome; angina pectoris (chest pain with negative troponin T with or without changes in electrocardiographic findings);\n2. Monovascular disease, preocclusive stenosis with TIMI(thrombolysis in myocardial infarction) \\> 1 on the left main or anterior descending branch of the left coronary artery\n3. Visually estimated diameter of the epicardial coronary artery from 2.5 mm to 4.0 mm\n\nFor group 2:\n\n1. Acute myocardial infarction with ST-segment elevation (ST-segment elevation\\> 0.1 mV in two or more leads, or\\> 0.2 mV in V1-V3) \\<6 hours from the onset of chest pain\n2. Symptoms of angina pectoris preceding acute myocardial infarction\n3. Monovascular disease, occlusion or preocclusive stenosis of the anterior descending branch of the left coronary artery with TIMI \\<1 flow in STEMI;\n4. After opening the artery and setting the stent TIMI\\> 2 flow\n5. Visually estimated epicardial coronary artery diameter up to 2.5 mm to 4.0 mm\n\nFor groups 3 and 4:\n\n1. Acute myocardial infarction with ST-segment elevation (ST-segment elevation\\> 0.1 mV in two or more leads, or\\> 0.2 mV in V1-V3) \\<6 hours from the onset of chest pain\n2. No symptoms of angina pectoris preceding acute myocardial infarction\n3. Monovascular disease, occlusion or preocclusive stenosis of the anterior descending branch of the left coronary artery with TIMI \\<1 flow in STEMI;\n4. After opening the artery and stent placement TIMI\\> 2 flow\n5. Visually estimated diameter of the epicardial coronary artery from 2.5 mm to 4.0 mm\n\nFor all groups:\n\n1. Age of patients over 18 years\n2. Signed written informed consent to be included in the survey\n\nExclusion Criteria:\n\n1. Cardiac arrest before or after PCI;\n2. Cardiogenic shock;\n3. Previous myocardial infarction or revascularization of the heart;\n4. Anginal pain before the onset of STEMI in patients to be subjected to RIC;\n5. Patients with end-stage renal or hepatic disease, diabetics with developed micro and macrovascular complications, oncology patients;\n6. Significant collaterals in the area of the occluded artery (Rentrop gradus\\> 1);\n7. Previous use of nitrates and corticosteroids;\n8. Pregnant or breastfeeding women;\n9. Iodine allergy (contrast media);\n10. Increase in body temperature \\> 37.5 ° C\n11. Participation in another clinical trial\n\nRandomly selected (coin toss) patients will be randomized to group 3 and 4, respectively, for percutaneous coronary intervention with or without RIC'}, 'identificationModule': {'nctId': 'NCT05230966', 'briefTitle': 'Immunometabolic Pattern of Intermittent Hypoxia During ST-segment Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Hospital Center Rijeka'}, 'officialTitle': 'Immunometabolic Pattern of Intermittent Hypoxia as a Protective Mechanism Against Lethal Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': '2170-29-02/1-21-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group 1- angina pectoris', 'description': 'Patients with acute coronary syndrome; angina pectoris (chest pain with negative troponin T with or without changes in electrocardiographic findings);'}, {'type': 'NO_INTERVENTION', 'label': 'Group 2 - angina pectoris + STEMI+ PCI', 'description': 'Patients with acute myocardial infarction with ST-segment elevation, \\< 6 hours from the onset of chest pain and preceding symptoms of angina pectoris with primary percutaneous coronary intervention.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3 - without angina pectoris + STEMi + RIC + PCI', 'description': "Patients with acute myocardial infarction with ST-segment elevation, \\< 6 hours from the onset of chest pain and without preceding symptoms of angina pectoris with primary percutaneous coronary intervention during which it's carried out remote ischemic conditioning (RIC)", 'interventionNames': ['Device: Remote Ischemic Conditioning (RIC)']}, {'type': 'NO_INTERVENTION', 'label': 'Group 4 - without angina pectoris + STEMI + PCI', 'description': 'Patients with acute myocardial infarction with ST-segment elevation, \\< 6 hours from the onset of chest pain and without preceding symptoms of angina pectoris with primary percutaneous coronary intervention.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 5 - healthy + RIC', 'description': 'healthy volunteers of the same age and sex, whose samples will be taken after the RIC procedure', 'interventionNames': ['Device: Remote Ischemic Conditioning (RIC)']}], 'interventions': [{'name': 'Remote Ischemic Conditioning (RIC)', 'type': 'DEVICE', 'description': 'RIC is a non-invasive method that achieves a state of intermittent hypoxia, and is performed by inflating the cuff of the pressure gauge on the left upper arm to 200 mmHg in 4 episodes of five-minute ischemia and reperfusion alternately for 45 minutes.', 'armGroupLabels': ['Group 3 - without angina pectoris + STEMi + RIC + PCI', 'Group 5 - healthy + RIC']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Koraljka Benko, MD', 'role': 'CONTACT', 'email': 'bkoraljka@yahoo.com', 'phone': '+38598462387'}], 'overallOfficials': [{'name': 'Koraljka Benko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHC Rijeka; Croatia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Hospital Center Rijeka', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Koraljka Benko', 'investigatorAffiliation': 'Clinical Hospital Center Rijeka'}}}}