Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 11:24 AM
Study NCT ID:
NCT05374694
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '* Overexpression in angina: miR-1-3p, miR-21-5p, miR-133a-3p, miR-133b-3p, miR-208a-3p, miR-208b-3p, miR-125a-5p, miR-187-3p , miR-499a-5p, miR-502-5p.\n* Underexpression in angina: miR-100-5p, miR-143-3p, miR-145-3p, miR-29b-5p. Open to explore other micro-RNAs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-10', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FFR', 'timeFrame': 'Intraprocedure', 'description': 'Fractional flow reserve'}, {'measure': 'IMR', 'timeFrame': 'Intraprocedure', 'description': 'Index of microvascular resistance'}, {'measure': 'Ach', 'timeFrame': 'Intraprocedure', 'description': 'Acetilcholine test'}], 'secondaryOutcomes': [{'measure': 'QCA', 'timeFrame': 'Intraprocedure', 'description': 'Quantitative Coronary Angiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary physiology', 'Biology', 'miRNA', 'Fractional flow reserve', 'Index of microcirculatory resistance', 'Angina pectoris'], 'conditions': ['Angina Pectoris']}, 'descriptionModule': {'briefSummary': "Relationship between invasive physiological assessment with FFR and IMR and biological markers as micro-RNA's according to coronary vascular compartiment affected (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3: Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). Also, biological markers will be related with presence of microvascular spasm or macrovascular spasm (Group 5).", 'detailedDescription': "Patients with chest pain suggestive of angina after ruling out other cardiac and non-cardiac causes, referred for invasive coronary angiography, will be evaluated by coronary angiography and invasive coronary physiological assessment by determining FFR and IMR and by performing a vasoreactivity test with acetylcholine.\n\nA relationship will be established between the invasive physiological assessment with FFR and IMR and biological markers such as micro-RNA's according to the affected coronary vascular compartment (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3 : Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). In addition, the biological markers will be related to the presence of microvascular spasm or macrovascular spasm (Group 5).\n\nFinally, among other biological markers, the following miRNAs will be compared. These miRNA's present consistent data in the literature about their over or underexpression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with angor pectoris referred for coronary angiography after excluding other cardiaca and non-cardiac causes of chest pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients with chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention.\n3. Echocardiogram ruling out noncoronary cardiac causes of chest pain.\n4. Informed consent.\n\nExclusion Criteria:\n\n1. Contrast allergy not susceptible to premedication.\n2. Severe bronchial asthma or adenosine intolerance.\n3. Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance.\n4. Acute myocardial infarction with ST-segment elevation.\n5. Acute myocardial infarction without ST-segment elevation.\n6. Cardiogenic shock.\n7. Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires.\n8. Previous coronary artery bypass grafting.\n9. Women with the possibility of being pregnant.\n10. Renal dysfunction with an estimated glomerular filtration rate \\<30 mL/min/1.73m2.\n11. Inability to understand the nature of the study and / or sign informed consent.\n12. Any other medical condition that, in the opinion of the researcher, may lead to safety issues for patients or may alter the results of the study.'}, 'identificationModule': {'nctId': 'NCT05374694', 'acronym': 'ANFIBIO', 'briefTitle': 'Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Arnau de Vilanova'}, 'officialTitle': 'Epigenetic Characterization of Angina Pectoris According to the Affected Coronary Compartment: Relationship Between Invasive Physiological Coronary Evaluation and Micro-RNAs', 'orgStudyIdInfo': {'id': 'CEIC-2665'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Macrovasculature + (FFR ≤ 0.80) / Microvasculature + (IMR ≥25)', 'interventionNames': ['Diagnostic Test: Physiological invasive coronary evaluation']}, {'label': 'Group 2', 'description': 'Macrovasculature + (FFR ≤ 0.80) / Microvasculature - (IMR \\<25)', 'interventionNames': ['Diagnostic Test: Physiological invasive coronary evaluation']}, {'label': 'Group 3', 'description': 'Macrovasculature - (FFR\\>0.80) / Microvasculature + (IMR ≥25)', 'interventionNames': ['Diagnostic Test: Physiological invasive coronary evaluation']}, {'label': 'Group 4', 'description': 'Macrovasculature - (FFR\\>0.80) / Microvasculature - (IMR \\<25)', 'interventionNames': ['Diagnostic Test: Physiological invasive coronary evaluation']}, {'label': 'Group 5', 'description': 'Microvascular spasm (\\<90% diameter contraction, Chest pain, ECG changes) or Macrovascular spasm (\\>90% diameter contraction, Chest pain, ECG changes)\n\n\\*Only patients in groups 3 and 4 will undergo the acetylcholine test.', 'interventionNames': ['Diagnostic Test: Physiological invasive coronary evaluation']}], 'interventions': [{'name': 'Physiological invasive coronary evaluation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25198', 'city': 'Lleida', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diego Fernández-Rodríguez, MD, PhD', 'role': 'CONTACT', 'email': 'dfernandez.lleida.ics@gencat.cat', 'phone': '651369729'}, {'name': 'Lucía Matute-Blanco, MD', 'role': 'CONTACT', 'email': 'lmatute.lleida.ics@gencat.cat', 'phone': '679252830'}], 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}], 'centralContacts': [{'name': 'Diego Fernández-Rodriguez, MD, PhD', 'role': 'CONTACT', 'email': 'dfernandez.lleida.ics@gencat.cat', 'phone': '+34-651369729'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'No specific time frame', 'ipdSharing': 'YES', 'accessCriteria': 'Each center will fill an anonymized and predefined case report form (CRF) developed by the investigators. The selected variables are oriented to the cardiovascular risk factors, comorbidities, clinical findings, ischemia detection tests, medications, analytical parameters, echocardiographic and angiographic findings, and invasive physiological indexes. All data collected during the study, after deidentification, will be shared. Data obtained through this study may be provided to qualified researchers with academic interest in cardiovascular diseases. Approval of the request and execution of all applicable agreements are prerequisites for the sharing of data with the requesting party.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Arnau de Vilanova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Diego Fernández-Rodríguez', 'investigatorAffiliation': 'Hospital Arnau de Vilanova'}}}}