[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495487":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":24,"centralContacts":28,"locations":33,"responsibleParty":50,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":10,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Takotsubo Syndrome",null,"Patients admitted to the Department of Cardiovascular Sciences of Fondazione Policlinico Universitario A. Gemelli IRCCS with a diagnosis of TTS. TTS will be diagnosed based on the most recent InterTAK Diagnostic Criteria. Myocarditis will be excluded based on clinical presentation (e.g.: previous flu-like symptoms, increased inflammatory biomarkers) and confirmed by cardiac magnetic resonance. We will further include all patients with a confirmed TTS diagnosis made between January 2016 and end of October 2022 (hypothetical beginning of prospective phase).",[13,14],"Other: Data extraction","Other: Clinical follow-up",[16,20],{"type":6,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"Data extraction","The exposure of patients to air pollution compounds in the two years prior to the occurrence of TTS will be analysed. We will investigate: PM10, PM2.5, O3, NO2, C6H6, SO2 e CO. Residential addresses will be obtained from medical records. Annual average 24-h of pollutants levels will be measured matching each individual's home address, and the \"ArpaLazio\" website (http:\u002F\u002Fwww.arpalazio.net\u002Fmain\u002Faria\u002Fsci\u002Fbasedati\u002Fchimici\u002Fchimici.php), which provides the concentration of NO, NO2, NOx, PM10, PM2.5, O3, CO, C6H6, SO2 expressed in micrograms per cubic meter (µg\u002Fm3). Hourly data are available for all gaseous pollutants, while the levels of PM10 and PM2.5 are expressed daily. Data will be obtained from the air quality monitor closest to each participant's residence that was active for the entire year, and short-term (daily and weekly) and long-term (annual) air pollution exposure will be quantified as daily, weekly, and annual average 24-h pollutants level of measurements before TTS.",[9],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Clinical follow-up","All patients will undergo a clinical follow-up by telephonic interview and\u002For clinical visit at 6, 12, 24, 36, 48 and 60 months from hospital discharge, during which the incidence of MACE, defined as the composite of all-cause mortality, non-fatal MI, transient ischemic attack (TIA)\u002Fstroke, and hospitalization for heart failure, and the recurrence of TTA in the past months will be investigated and collected.",[9],[25],{"name":26,"affiliation":5,"role":27},"Rocco A Montone, MD, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","+39-0630154187","roccoantonio.montone@policlinicogemelli.it",[34],{"facility":35,"status":36,"city":37,"state":10,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Fondazione Policlinico Universitario A. Gemelli IRCCS","RECRUITING","Rome","00168","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],12.51133,41.89193,{"lat":45,"lon":44},[48],{"name":49,"role":30,"phone":31,"phoneExt":10,"email":32},"Rocco Montone, MD, PhD",{"type":27,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"MONTONE ROCCO ANTONIO","IRCCS Researcher","100495487","takotsubo-syndrome-and-air-pollution-100495487",false,"NCT05731830","Takotsubo Syndrome and Air Pollution","Takotsubo Syndrome and Air Pollution: the \"Tako-Air\" Study","Tako-Air","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of TTS.\n* Available data for short-term and\u002For long-term exposure to air pollutants (see below).\n* Written informed consent to participate.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years.\n* Not available data for short-term and\u002For long-term exposure to air pollutants.","ALL","18 Years",{"count":64,"type":65},250,"ESTIMATED","OBSERVATIONAL","Takotsubo syndrome (TTS) is an acute and reversible form of myocardial injury characterized by typical regional wall motion abnormalities in the absence of culprit epicardial coronary artery disease frequently precipitated by significant emotional stress or serious physical illness. The clinical presentation is usually similar to acute myocardial infarction (MI), with chest pain and\u002For dyspnea, ST-segment elevation or depression and\u002For T-wave inversion on the resting electrocardiogram (ECG) and elevation of serum cardiac troponin. Although previously considered a benign disease, it is now clear that TTS is associated with severe acute complications during the acute phase including hemodynamic and electrical instability and up to 5% of in-hospital mortality.\n\nThe pathogenetic mechanisms of air pollution are likely to predispose to the occurrence as well as to mediate a worse clinical presentation and outcome of TTS, proving air pollution as a TTS risk factor.",[9],[70,9,71],"Air Pollution","Stress cardiomyopathy","2024-02-23",{"date":74,"type":75},"2024-02-26","ACTUAL",{"date":77,"type":75},"2022-11-15",{"date":79,"type":65},"2026-11",{"name":5,"class":6},1]