Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05111418
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2021-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054084', 'term': 'Myocardial Bridging'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D003330', 'term': 'Coronary Vessel Anomalies'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2021-10-27', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of MACE', 'timeFrame': '2 years follow up', 'description': 'Incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization and target vessel revascularization'}], 'secondaryOutcomes': [{'measure': 'Rate of patients with SAQ < 70', 'timeFrame': '2 years follow up'}, {'measure': 'Rate of patients with "high risk features" on CT scan', 'timeFrame': '2 years follow up', 'description': 'High risk features'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myocardial Bridge', 'MACE', 'Ischemia', 'Beta-blockers', 'Coronary angiography', 'Personalised medicine'], 'conditions': ['Myocardial Bridge']}, 'descriptionModule': {'briefSummary': 'Myocardial bridge (MB) is a congenital anomaly of epicardial circulation characterized by an intramural course of a coronary segment. This anatomical arrangement causes the artery to be squeezed during systole potentially causing flow impairment and ischemia. For this study, MB is defined as the presence of systolic compression in an epicardial vessel causing at least 50% of caliber reduction from diastole. MB can be disabling as it worsens the quality of life. Early detection of this congenital condition is crucial, and an invasive functional assessment of the ischemic burden should be considered to evaluate the need for medical or surgical therapy.\n\nThis is an observational study, involving four Italian centres. Study Objectives are: To assess the risk of future cardiovascular complications in patients with MB referred for coronary angiography and the role of beta-blocker therapy; To describe the clinical and anatomical characteristics of patients presenting with MB; To determine the impact of cardiovascular medications on symptoms in patients with MB; To describe the anatomical and clinical features associated with the invasive evidence of ischemia in patients with MB; To assess the relation between invasively documented ischemia and clinical manifestations in patients with the MB. Inclusion Criteria: patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have an MB with or without other epicardial lesions amenable to revascularization; Age above 18 y.o.; Ability to provide Informed Consent. Exclusion Criteria are Patients with life expectancy below 12 months and Patients with severe valvular heart disease. The primary endpoint is the incidence of MACE defined as the composite of cardiac death, myocardial infarction, cardiac hospitalization, and target vessel revascularization. The secondary endpoint is evaluating the Rate of patients with SAQ \\< 70 and the Rate of patients with "high-risk features" on CT scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population with suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to undergo ICA (for both elective or urgent indications) for suspected coronary artery disease found to have a myocardial bridge with or without other epicardial lesions amenable to revascularization\n* Age above 18 y.o.\n* Ability to provide Informed Consent\n\nExclusion Criteria:\n\n* Patients with life expectancy below 12 months\n* Patients with severe valvular heart disease'}, 'identificationModule': {'nctId': 'NCT05111418', 'acronym': 'RIALTO', 'briefTitle': 'Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Myocardial Bridge Evaluation Towards Personalised Medicine: the RIALTO Registry', 'orgStudyIdInfo': {'id': '3812'}}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Ferrara', 'state': 'Italia', 'country': 'Italy', 'facility': 'Arcispedale S. Anna, Azienda Ospedaliero - Universitaria di Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '16132', 'city': 'Genova', 'state': 'Italia', 'country': 'Italy', 'facility': 'Policlinico S. Martino IRCCS, Università di Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20138', 'city': 'Milan', 'state': 'Italia', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00168', 'city': 'Roma', 'state': 'Italia', 'country': 'Italy', 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Universitario Tor Vergata Fondazione PTV', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'DAMARIO DOMENICO', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}