Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 7:18 AM
Study NCT ID:
NCT06125392
Status:
RECRUITING
Last Update Posted:
2024-11-01
First Post:
2023-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}, {'id': 'D003329', 'term': 'Coronary Vasospasm'}], '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': 'D003327', 'term': 'Coronary Disease'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2023-11-04', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of endotypes of coronary vasomotor function', 'timeFrame': 'immediately after the invasive measurement', 'description': 'Patients will be classified in different endotypes according to the pattern of their responses to endothelium-dependent and independent vasodilators.'}], 'secondaryOutcomes': [{'measure': 'Accuracy of clinical criteria for the diagnosis of microvascular and epicardial spasm', 'timeFrame': 'immediately after the invasive measurement', 'description': 'The clinical criteria commonly used for the diagnosis of spasm (based on ECG and angina) will be validated against the benchmark invasive measurements'}, {'measure': 'Normal values expressing endothelium-dependent coronary flow reserve', 'timeFrame': 'immediately after the invasive measurement', 'description': 'Acetylcholine-induced coronary flow reserve in subjects without microvascular dysfunction.'}, {'measure': 'Sex impact on coronary vasospasm measures', 'timeFrame': 'immediately after the invasive measurement', 'description': 'Difference between males and females in microvascular and epicardial spasm measures'}, {'measure': 'Coronary bridge and epicardial spasm', 'timeFrame': 'immediately after the invasive measurement', 'description': 'Impact of coronary brudge on the incidence of epicaridal spasm'}, {'measure': 'Acetylcholine versus adenosine responses', 'timeFrame': 'immediately after the invasive measurement', 'description': 'Comparison of adenosine- versus acetylcholin-induced microvascular dilatation (IMR)'}, {'measure': 'Normal values and associations of resting microvascular resistances', 'timeFrame': 'Immediately upon measurment', 'description': 'We will assess the normal values of resting microvascular resistances using a frequentistic approach and study their associations with comorbidities and clinical parameters.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Microvascular Disease', 'Coronary Vasospasm']}, 'descriptionModule': {'briefSummary': 'The MICRO-SNAPE registry will collect data from patients undergoing investigation of microvascular dysfunction and coronary spasm in Europe and North America.', 'detailedDescription': "Microvascular dysfunction is an important determinant of patients´quality of life and prognosis, which however remains poorly classified. Given the high burden of disease and the severity of the functional impairment in these patients, the lack of a clear understanding and diagnosis has a potentially large clinical importance. It is therefore important to better describe the phenotype of these patients. The MICRO-SNAPE registry will allow investigating these associations. Patient data as collected during the local clinical practice and at the operator's discretion, will be retrospectively entered in this non-interventional registry in anonymous form."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with angina but no epicardial disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent combined measurements of coronary pressure and flow in at least 1 native coronary artery in response to endothelium dependent and independent vasodilators.\n\nExclusion Criteria:\n\n* Hemodynamic instability\n* Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT06125392', 'acronym': 'MICRO-SNAPE', 'briefTitle': 'Multicenter Registry on Microvascular Dysfunction - Searching a New Ach Spasm Definition', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'A Multicenter RegIstry on the Diagnosis of Patients with Chronic Angina and No Angiographic CoRonary Artery Stenosis (international Retrospective Collection of Anonymized Patient Data) - Searching a New Ach Spasm Definition', 'orgStudyIdInfo': {'id': 'UM 20-0274'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Invasive assessment of coronary vasomotor function', 'description': 'All lesions undergoing assessment of coronary microvascular dysfunction and coronary spasm using coronary pressure wires.', 'interventionNames': ['Diagnostic Test: Coronary physiology assessment']}], 'interventions': [{'name': 'Coronary physiology assessment', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Parameters of coronary physiology in response to microvascular vasodilators (adenosine, papaverine) and acetylcholine'], 'description': 'Resting distal coronary to aortic pressure ratio, resting flow ratio, fractional flow reserve, Coronary Flow Reserve and Microvascular resistance using the thermodilution method and papaverin or adenosine, Resting distal coronary to aortic pressure ratio, resting flow ratio, fractional flow reserve, Coronary Flow Reserve and Microvascular resistance using the thermodilution method and acetylcholine.', 'armGroupLabels': ['Invasive assessment of coronary vasomotor function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tommaso Gori, Prof Dr, PhD', 'role': 'CONTACT', 'email': 'tommaso.gori@unimedizin-mainz.de', 'phone': '+49 (0) 6131 17 2729'}, {'name': 'Tommaso Gori, Prof Dr, PhD', 'role': 'CONTACT'}], 'facility': 'Center of Cardiology, Cardiology I, university hospital Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Upon legitimate request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Tommaso Gori', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}