[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537687":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":299,"collaborators":302,"id":304,"slug":305,"hasResults":306,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":306,"sex":312,"minAge":313,"maxAge":314,"enrollmentInfo":315,"targetDuration":24,"studyType":318,"phases":319,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":163,"whyStopped":24,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":336},{"fullName":5,"class":6},"Azienda Ospedaliero Universitaria Maggiore della Carita","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"\"full-physiology approach\" arm","EXPERIMENTAL","In the \"full-physiology approach\" arm, patients will be, during CA, simultaneously subjected to a full interventional diagnostic procedure, including:\n\n* resting distal coronary pressure to aortic pressure ratio (Pd\u002FPa);\n* fractional flow reserve (FFR) after intravenous adenosine administration;\n* Resting Ful-Cycle Ratio (RFR);\n* coronary flow reserve (CFR) and index of microvascular resistance (IMR);\n* assessment of FFR, CFR and IMR after inotropic stimulation with dobutamine (respectively FFR-d, CFR-d and IMR-d);\n* acetylcholine (ACH) provocative test.",[13],"Diagnostic Test: \"full-physiology approach\" arm",{"label":15,"type":6,"description":16,"interventionNames":17},"\"standard approach\" arm","In the \"standard approach\" arm, patients will undergo only an angiographic evaluation, without any invasive intracoronary assessment.",[18],"Diagnostic Test: \"standard approach\" arm",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","* All MB patients belonging to the full-physiology arm will undergo functional assessment of the intramural artery with basal Pd\u002FPa, FFR (after intravenous adenosine), RFR, CFR and IMR.\n* In the presence of a negative functional assessment (Pd\u002FPa\\> 0.92, FFR\\> 0.80, RFR\\> 0.89, CFR≥ 2.0 and IMR\\\u003C 25), FFR, CFR and IMR will be measured after inotropic stimulation with dobutamine (respectively FFR-d, CFR-d and IMR-d) to exalt the epicardial hemodynamic significance of MB or its impact on structural microvascular remodelling (impaired endothelium-independent vasodilatation).\n* In the absence of epicardial hemodynamic significance (FFR-d\\> 0.75) and structural microvascular dysfunction (CFR≥ 2.0 and IMR\\\u003C 25), ACH provocative test will be performed to evaluate the presence of epicardial or microvascular spasm (impaired endothelium-dependent vasodilatation).",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"In the \"standard approach\" arm patients will undergo an angiographic evaluation of the tunnelled artery",[15],[29],{"name":30,"affiliation":31,"role":32},"Giuseppe Patti, Prof","Università degli Studi del Piemonte Orientale Amedeo Avogadro","STUDY_CHAIR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Domenico D'Amario, Prof","CONTACT","0039 0321 3733141","domenico.damario@uniupo.it",[40,52,60,68,76,84,92,100,108,116,124,132,140,148,153,161,176,184,192,200,208,216,224,229,234,239,244,249,254,262,270,278,283,291],{"facility":41,"status":42,"city":43,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":24},"Ospedale Generale Regionale F. Miulli","NOT_YET_RECRUITING","Acquaviva delle Fonti","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],16.8433,40.89704,{"lat":50,"lon":49},{"facility":53,"status":42,"city":54,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":55,"geoPoint":59,"contacts":24},"Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo","Alessandria",{"type":47,"coordinates":56},[57,58],8.61007,44.90924,{"lat":58,"lon":57},{"facility":61,"status":42,"city":62,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":24},"Ospedale San Donato","Arezzo",{"type":47,"coordinates":64},[65,66],11.88068,43.46276,{"lat":66,"lon":65},{"facility":69,"status":42,"city":70,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":71,"geoPoint":75,"contacts":24},"ASST Papa Giovanni XXIII","Bergamo",{"type":47,"coordinates":72},[73,74],9.66721,45.69601,{"lat":74,"lon":73},{"facility":77,"status":42,"city":78,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":24},"Ospedale degli Infermi di Biella","Biella",{"type":47,"coordinates":80},[81,82],8.05796,45.56304,{"lat":82,"lon":81},{"facility":85,"status":42,"city":86,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":87,"geoPoint":91,"contacts":24},"Policlinico S. Orsola IRCCS Azienda Ospedaliero Universitaria","Bologna",{"type":47,"coordinates":88},[89,90],11.33875,44.49381,{"lat":90,"lon":89},{"facility":93,"status":42,"city":94,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":95,"geoPoint":99,"contacts":24},"Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano","Caserta",{"type":47,"coordinates":96},[97,98],14.33231,41.07262,{"lat":98,"lon":97},{"facility":101,"status":42,"city":102,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":103,"geoPoint":107,"contacts":24},"Villa Maria Cecilia Hospital","Cotignola",{"type":47,"coordinates":104},[105,106],11.93852,44.38572,{"lat":106,"lon":105},{"facility":109,"status":42,"city":110,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":111,"geoPoint":115,"contacts":24},"Azienda Ospedaliero Universitaria di Ferrara","Ferrara",{"type":47,"coordinates":112},[113,114],11.62057,44.83804,{"lat":114,"lon":113},{"facility":117,"status":42,"city":118,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":119,"geoPoint":123,"contacts":24},"Azienda Ospedaliero Universitaria Careggi","Florence",{"type":47,"coordinates":120},[121,122],11.24626,43.77925,{"lat":122,"lon":121},{"facility":125,"status":42,"city":126,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":127,"geoPoint":131,"contacts":24},"Azienda Ospedaliera Universitaria Policlinico San Martino","Genova",{"type":47,"coordinates":128},[129,130],11.87211,45.21604,{"lat":130,"lon":129},{"facility":133,"status":42,"city":134,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":135,"geoPoint":139,"contacts":24},"Ospedale Della Misericordia","Grosseto",{"type":47,"coordinates":136},[137,138],11.10941,42.76296,{"lat":138,"lon":137},{"facility":141,"status":42,"city":142,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":143,"geoPoint":147,"contacts":24},"Centro Cardiologico Monzino IRCCS","Milan",{"type":47,"coordinates":144},[145,146],12.59836,42.78235,{"lat":146,"lon":145},{"facility":149,"status":42,"city":142,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":150,"geoPoint":152,"contacts":24},"IRCCS Ospedale Galeazzi",{"type":47,"coordinates":151},[145,146],{"lat":146,"lon":145},{"facility":154,"status":42,"city":155,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":156,"geoPoint":160,"contacts":24},"Fondazione IRCCS San Gerardo dei Tintori","Monza",{"type":47,"coordinates":157},[158,159],9.27246,45.58005,{"lat":159,"lon":158},{"facility":162,"status":163,"city":164,"state":24,"zip":165,"country":44,"countryCode":45,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"AOU Maggiore della Carità","RECRUITING","Novara","28100",{"type":47,"coordinates":167},[168,169],8.62118,45.44694,{"lat":169,"lon":168},[172,173,175],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},{"name":35,"role":174,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"name":30,"role":174,"phone":24,"phoneExt":24,"email":24},{"facility":177,"status":42,"city":178,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":179,"geoPoint":183,"contacts":24},"Azienda Ospedaliero Universitaria di Parma","Parma",{"type":47,"coordinates":180},[181,182],10.32618,44.79935,{"lat":182,"lon":181},{"facility":185,"status":42,"city":186,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":187,"geoPoint":191,"contacts":24},"Azienda Ospedaliera di Perugia","Perugia",{"type":47,"coordinates":188},[189,190],12.38878,43.1122,{"lat":190,"lon":189},{"facility":193,"status":42,"city":194,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":195,"geoPoint":199,"contacts":24},"Azienda Ospedaliero Universitaria Pisana","Pisa",{"type":47,"coordinates":196},[197,198],10.4036,43.70853,{"lat":198,"lon":197},{"facility":201,"status":42,"city":202,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":203,"geoPoint":207,"contacts":24},"Ospedale San Jacopo","Pistoia",{"type":47,"coordinates":204},[205,206],10.92365,43.93064,{"lat":206,"lon":205},{"facility":209,"status":42,"city":210,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":211,"geoPoint":215,"contacts":24},"Ospedali Riuniti di Rivoli","Rivoli",{"type":47,"coordinates":212},[213,214],7.51465,45.07073,{"lat":214,"lon":213},{"facility":217,"status":42,"city":218,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":219,"geoPoint":223,"contacts":24},"Aurelia Hospital","Roma",{"type":47,"coordinates":220},[221,222],11.10642,44.99364,{"lat":222,"lon":221},{"facility":225,"status":42,"city":218,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":226,"geoPoint":228,"contacts":24},"Azienda Ospedaliera San Camillo-Forlanini",{"type":47,"coordinates":227},[221,222],{"lat":222,"lon":221},{"facility":230,"status":42,"city":218,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":231,"geoPoint":233,"contacts":24},"Azienda Ospedaliero Universitaria Sant'Andrea",{"type":47,"coordinates":232},[221,222],{"lat":222,"lon":221},{"facility":235,"status":163,"city":218,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":236,"geoPoint":238,"contacts":24},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"type":47,"coordinates":237},[221,222],{"lat":222,"lon":221},{"facility":240,"status":42,"city":218,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":241,"geoPoint":243,"contacts":24},"Ospedale Sandro Pertini",{"type":47,"coordinates":242},[221,222],{"lat":222,"lon":221},{"facility":245,"status":42,"city":218,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":246,"geoPoint":248,"contacts":24},"Ospedale Santo Spirito",{"type":47,"coordinates":247},[221,222],{"lat":222,"lon":221},{"facility":250,"status":42,"city":218,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":251,"geoPoint":253,"contacts":24},"Policlinico Universitario Tor Vergata Fondazione PTV",{"type":47,"coordinates":252},[221,222],{"lat":222,"lon":221},{"facility":255,"status":42,"city":256,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":257,"geoPoint":261,"contacts":24},"Ospedale Civile Santissima Annunziata","Sassari",{"type":47,"coordinates":258},[259,260],8.55552,40.72586,{"lat":260,"lon":259},{"facility":263,"status":42,"city":264,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":265,"geoPoint":269,"contacts":24},"Azienda Sanitaria Provinciale di Siracusa","Syracuse",{"type":47,"coordinates":266},[267,268],15.28664,37.07542,{"lat":268,"lon":267},{"facility":271,"status":42,"city":272,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":273,"geoPoint":277,"contacts":24},"Azienda Ospedaliera Ordine Mauriziano","Torino",{"type":47,"coordinates":274},[275,276],11.99138,44.88856,{"lat":276,"lon":275},{"facility":279,"status":42,"city":272,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":280,"geoPoint":282,"contacts":24},"Azienda Ospedaliero Universitaria Città Della Salute E Scienza",{"type":47,"coordinates":281},[275,276],{"lat":276,"lon":275},{"facility":284,"status":42,"city":285,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":286,"geoPoint":290,"contacts":24},"Presidio Ospedaliero Sant'Andrea","Vercelli",{"type":47,"coordinates":287},[288,289],8.41989,45.32163,{"lat":289,"lon":288},{"facility":292,"status":42,"city":293,"state":24,"zip":24,"country":44,"countryCode":45,"cosmosGeoPoint":294,"geoPoint":298,"contacts":24},"Azienda Ospedaliera Universitaria Integrata, Ospedale Borgo Trento","Verona",{"type":47,"coordinates":295},[296,297],10.9938,45.43854,{"lat":297,"lon":296},{"type":174,"investigatorFullName":300,"investigatorTitle":301,"investigatorAffiliation":31,"oldNameTitle":24,"oldOrganization":24},"Domenico D'Amario","Prof",[303],{"name":31,"class":6},"100537687","reassessment-of-myocardial-bridge-towards-personalized-medicine-100537687",false,"NCT06281067","Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine","Reassessment of myocardIAL Bridge TOwards PeRsOnalized Medicine: RIALTO PRO","RIALTO PRO","Inclusion Criteria:\n\n1. Ability to give informed consent to the study.\n2. Age ≥ 18 years and ≤ 75 years.\n3. Diagnosis of MB during index coronary angiography\\*.\n4. Symptoms or signs of inducible ischemia (if signs, these should involve the territory of the index vessel).\n\nAngiographic definition of MB \\*\n\nMyocardial bridge is a congenital anomaly characterized by an intramural course of an epicardial coronary segment. This anatomical arrangement causes the artery to be squeezed during systole, with a relaxation in diastole. In this study, MB is defined as a visual ≥ 50% reduction in the minimal luminal diameter during systole and a complete or partial relaxation in diastole (\"milking effect\").\n\nThe use of intracoronary vasodilators (i.e., nitrates) can increase the systolic narrowing of the vessel, through a reflex rise of the adrenergic drive, and consequently the angiographic sensitivity in detecting MB.\n\nExclusion Criteria:\n\n1. Moderate to severe CAD (≥ 50% stenosis in any vessel, including chronic total occlusion) at the time of enrolment\u002Frandomization.\n2. Previous CABG involving the index vessel.\n3. Severe valvular heart disease.\n4. Left ventricular systolic dysfunction \\[ejection fraction (EF) \\\u003C 40%\\], regardless of the etiology.\n5. Clinically significant right ventricular dysfunction.\n6. Known severe renal impairment (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2).\n7. Known severe hepatic impairment, or history of cirrhosis with evidence of portal hypertension.\n8. History of malignancy of any organ system with a life expectancy \\\u003C 1 year.\n9. Any previous history of ischemic stroke, intracranial haemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).\n10. Pregnant or breastfeeding women.\n11. Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (nitrates, adenosine, dobutamine, acetylcholine).","ALL","18 Years","75 Years",{"count":316,"type":317},500,"ESTIMATED","INTERVENTIONAL",[320],"NA","The \"RIALTO-PRO\" study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge (MB) patients, testing the diagnostic value of a full invasive diagnostic procedure, and, consequently, the prognostic value of a tailored approach. the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB.\n\nThe \"RIALTO PRO\" study is a randomized, multicentre, prospective, open-label, superiority trial comparing a personalised versus standard management in patients with MB. Consenting and eligible patients will be randomised 1:1 to either a \"full-physiology approach\", consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment, or a \"standard approach\", consisting of angiographic evaluation of the tunnelled segment.",[323],"Myocardial Bridge",[325,326],"myocardial bridge","Personalized Medicine","2024-07-09",{"date":329,"type":330},"2024-07-10","ACTUAL",{"date":332,"type":330},"2023-12-15",{"date":334,"type":317},"2026-01-01",{"name":5,"class":6},34]