[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535734":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":45,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients undergoing PCI",null,"Assessment of ΔvFFR and vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) in patients with CCS or ACS.",[13],"Diagnostic Test: Angiography-based vessel fractional flow reserve (vFFR) calculation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Angiography-based vessel fractional flow reserve (vFFR) calculation","vFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands)",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Mariusz Tomaniak, MD PhD","CONTACT","+48 22 5991951","mariusz.tomaniak@wum.edu.pl",{"name":27,"role":23,"phone":10,"phoneExt":10,"email":28},"Karol Sadowski","karol.sadowski@wum.edu.pl",[30],{"facility":5,"status":31,"city":32,"state":10,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Warsaw","02-097","Poland","PL",{"type":37,"coordinates":38},"Point",[39,40],21.01178,52.22977,{"lat":40,"lon":39},[43],{"name":44,"role":23,"phone":10,"phoneExt":10,"email":25},"Mariusz Tomaniak, MD, PhD",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Mariusz Tomaniak","Tomaniak Mariusz MD PhD Assoc. Prof.","100535734","angio-based-final-functional-effect-of-pci-100535734",false,"NCT06255678","Angio-based Final Functional Effect of PCI","Angio-based Final Functional Effect of PCI (AFFE PCI): a Prospective Multi-center Study of Post-PCI vFFR Impact on Clinical Outcomes and Residual Angina","AFFE-PCI","Inclusion Criteria:\n\n* Percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)\n* Adequate quality of angiogram enabling vFFR analysis (available two angiographic views with ≥30° differences in rotation\u002Fangulation, the possibility of vessel contour selection, proper quality of the images, vessels without severe overlapping, tortuosity, foreshortening and poor vessel opacification)\n* Age \\>18 years\n* The patient's written informed consent has been obtained before the procedure\n\nExclusion Criteria:\n\n* Cardiogenic shock, pulmonary oedema\n* Severe hemodynamical instability\n* Prior coronary artery bypass grafting (CABG)\n* Active bleeding\n* Acute and chronic inflammatory conditions\n* Acute mechanical complications of myocardial infarction\n* Congenital heart disease\n* Heart transplantation\n* Non-cardiac comorbidities with a life expectancy of less than 1 year","ALL","18 Years",{"count":60,"type":61},2005,"ESTIMATED","2 Years","OBSERVATIONAL","Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health.\n\nThis is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.",[66,67,68],"Acute Coronary Syndrome","Non ST Segment Elevation Acute Coronary Syndrome","Chronic Coronary Syndrome",[70,71,72,73,74,75],"vFFR","ACS","NST-ACS","Angiography-based FFR","Quality of life","Residual angina","2024-02-02",{"date":78,"type":79},"2024-02-13","ACTUAL",{"date":81,"type":79},"2023-07-03",{"date":83,"type":61},"2027-01-01",{"name":5,"class":6},1]