Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-03 @ 2:01 AM
Study NCT ID:
NCT06597851
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Resistance and Coronary Microvascular Dysfunction in Patients with Myocardial Ischemia and Non-obstructive Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, experimental, single-arm, explorative study. The study aims to perform a functional study of the coronary microcirculation with pressure guides, in patients with angina and non obstructive coronary artery disease. Also a tranthoracic echocardiography will be performed. Following this, the patient will undergo hyperinsulinemic-euglycemic clamp test to evaluate insulin resistance and the metabolic risk. The primary endpoint is to assess the correlation between the index of microcirculatory resistance and the M-value evaluated with clamp test as a measure of insulin resistance. Follow up will continue up to 1 year from enrollment through telephone contacts, outpatient visits and review of clinical data.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-12', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between coronary microvascular dysfunction and insulin resistance', 'timeFrame': 'At baseline', 'description': 'Correlation between the index of microcirculatory resistance (IMR) and the M-value evaluated with the hyperinsulinemic-euglycemic clamp test as a measure of insulin resistance'}], 'secondaryOutcomes': [{'measure': 'Correlation in vasomotor function in patients with and without IR', 'timeFrame': 'At baseline', 'description': 'Difference in vasomotor dysfunction at vasoreactivity test with acetylcholine in patients with and without IR'}, {'measure': 'Adverse clinical events', 'timeFrame': '12 months', 'description': 'Composite of cardiovascular death, new hospitalization for HF and/or ACS during follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Microvascular Dysfunction', 'Coronary Microvascular Disease', 'Insulin Resistance', 'INOCA', 'ANOCA', 'CMD', 'hyperinsulinemic-euglycemic clamp test'], 'conditions': ['Coronary Microvascular Dysfunction', 'Coronary Microvascular Disease', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The goal of this prospective study is to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA.\n\nPatients with ANOCA and without diabetes will undergo invasive coronary microvascular assessment through coronary angiography and insulin resistance assessment through hyperinsulinemic-euglycemic clamp test.\n\nPatients enrolled in the study will be followed for a period of 2 years to monitor their clinical status.', 'detailedDescription': 'This is a prospective, experimental, single-center, explorative study designed to assess the correlation between coronary microvascular disfunction and insulin resistance in patients with INOCA.\n\nPatients identified as eligible for the protocol will be asked for written informed consent to participate in the study.\n\nParticipants will undergo multimodality diagnostic tests as per standard clinical practice and international recommendations:\n\n1. Fasting glucose, fasting insulin, HOMA index, glycated haemoglobin and oral glucose tolerance test (OGTT) will be assessed to rule out diabetes.\n2. Transthoracic echocardiography will be performed to evaluate cardiac function and cardiac remodeling.\n3. Coronary angiography will be performed to rule out obstructive CAD defined as angiographic stenosis ≥ 70% of one or more main epicardial coronary arteries (defined as vessels with diameter \\>2.0 mm) and/or fractional flow reserve (FFR) ≤ 0,80 as indicated by the latest European Guidelines.\n4. In case of angiographic evidence of unobstructive CAD, participants will undergo coronary microvascular function assessment using standard coronary pressure guidewire as indicated by the latest European Guidelines according to the recently described Fullphysiology method. If clinically indicated, in case of suspected epicardial or microvascular spasm, endothelial-dependent vasomotor function will be evaluated using a standard vasoreactivity test based on incremental doses of acetylcoline infusion as indicated by the latest European Guidelines.\n5. Patients will undergo hyperinsulinemic-euglycemic clamp test at Diabetology Unit of AOUI Verona to evaluate insulin resistance and the metabolic risk. In patients with no clinical concerns, adequate pharmacological washout from betablockers, ace inhibitors, sartans and/or calcium antagonists will be considered before performing the clamp test.\n6. Patients will undergo clinical follow up at 6 and 12 months via outpatient clinic or telephone contacts. Fasting glucose, fasting insulin, HOMA index and glycated haemoglobin will be re-assessed at 12 months.\n7. Transthoracic echocardiography will be repeated at 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged over 18 years.\n* Cardiac chest pain with evidence of myocardial ischemia at noninvasive myocardial stress imaging and clinical indication to diagnostic coronary angiography\n* Willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Obstructive CAD (defined as more than 70% luminal stenosis and/or FFR ≤0.80 in 1 or more epicardial vessels).\n* History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery.\n* Diagnosis of type II diabetes.\n* BMI ≥ 35 kg/m2.\n* Stage IV and V of chronic kidney disease (eGFR ≤ 30 ml/min, estimated through CKD - EPI Creatinine Equation).\n* Allergy or other contraindication to iodinated contrast and/or gadolinium and/or adenosine.\n* Chronic resting O2 saturation ≤ 85%.\n* Pregnancy or suspected pregnancy.'}, 'identificationModule': {'nctId': 'NCT06597851', 'acronym': 'IRIN', 'briefTitle': 'Insulin Resistance and Coronary Microvascular Dysfunction in Patients with Myocardial Ischemia and Non-obstructive Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Universitaria Integrata Verona'}, 'officialTitle': 'Insulin Resistance and Coronary Microvascular Dysfunction in Patients with Myocardial Ischemia and Non-obstructive Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'IRIN (225CET)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non-diabetic patients with ANOCA', 'description': '* Thermodilution based assessment of coronary microcirculation with the derivation of CFR and IMR\n* Hyperinsulinemic euglycemic clamp for insulin resistance assessment', 'interventionNames': ['Diagnostic Test: Thermodilution based assessment of coronary microcirculation', 'Diagnostic Test: Hyperinsulinemic-euglycemic Clamp test']}], 'interventions': [{'name': 'Thermodilution based assessment of coronary microcirculation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Coronary microvascular assessment with the derivation of CFR, IMR and MRR will be performed using a standard pressure/thermodilution guidewire.', 'armGroupLabels': ['Non-diabetic patients with ANOCA']}, {'name': 'Hyperinsulinemic-euglycemic Clamp test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Infusion of insulin and glucose adjusting rate of glucose infusion to maintaine plasma glucose around 90 mg/dL by monitoring plasma glucose levels every 5-10 minutes', 'armGroupLabels': ['Non-diabetic patients with ANOCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37126', 'city': 'Verona', 'state': 'VR', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Flavio Luciano Ribichini', 'role': 'CONTACT', 'email': 'flavio.ribichini@univr.it', 'phone': '0039 0458122320'}, {'name': 'Roberto Scarsini, MD PhD', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera Universitaria di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Natascia Antonioli', 'role': 'CONTACT', 'email': 'studi.clinici.cardiologia@aovr.veneto.it', 'phone': '0039 0458122320'}], 'overallOfficials': [{'name': 'Roberto Scarsini MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera Universitaria di Verona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Universitaria Integrata Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Roberto Scarsini', 'investigatorAffiliation': 'Azienda Ospedaliera Universitaria Integrata Verona'}}}}