[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434595":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":47,"locations":55,"responsibleParty":118,"collaborators":121,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":127,"sex":133,"minAge":134,"maxAge":31,"enrollmentInfo":135,"targetDuration":31,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":58,"whyStopped":31,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"CT-derived FFR","EXPERIMENTAL","In this study arm, the need for coronary revascularization will be determined by CT-derived Fractional Flow Reserve (FFR) calculations",[13],"Diagnostic Test: CT-FFR",{"label":15,"type":10,"description":16,"interventionNames":17},"Angiography-derived FFR","In this study arm, the need for coronary revascularization will be determined by FFR-calculations derived from angiographic images",[18],"Diagnostic Test: Angiography-derived FFR",{"label":20,"type":21,"description":22,"interventionNames":23},"Routine Care","ACTIVE_COMPARATOR","In this study arm, the need for coronary revascularization will be determined by angiography and invasive FFR-measurements",[24],"Diagnostic Test: Angiography with invasive FFR-measurements",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DIAGNOSTIC_TEST","CT-FFR","CT-images will be processed by an algorithm to calculate FFR-values of the full coronary tree",[9],null,{"type":27,"name":15,"description":33,"armGroupLabels":34,"otherNames":31},"FFR-values are calculated during coronary angiography based on the acquired images of the coronary arteries",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":31},"Angiography with invasive FFR-measurements","during coronary angiography, a specialized pressure wire is passed through the coronary stenosis to calculate FFR based on the difference between the actual pressure and the expected pressure in the hypothetical healthy coronary artery.",[20],[40,44],{"name":41,"affiliation":42,"role":43},"Martin J Swaans, Dr.","St. Antonius Ziekenhuis Nieuwegein","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":46,"role":43},"Tim Leiner, Prof. Dr.","UMC Utrecht",[48,52],{"name":41,"role":49,"phone":50,"phoneExt":31,"email":51},"CONTACT","+31 (0)88 320 0900","m.swaans@antoniusziekenhuis.nl",{"name":53,"role":49,"phone":50,"phoneExt":31,"email":54},"Mike Bosschaert, Drs.","m.bosschaert@antoniusziekenhuis.nl",[56,77,91,104],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Catharina Hospital","RECRUITING","Eindhoven","North Brabant","5623EJ","Netherlands","NL",{"type":65,"coordinates":66},"Point",[67,68],5.47778,51.44083,{"lat":68,"lon":67},[71,75],{"name":72,"role":49,"phone":73,"phoneExt":31,"email":74},"Leonie M Becker, MD","+31629642180","l.becker@antoniusziekenhuis.nl",{"name":76,"role":49,"phone":31,"phoneExt":31,"email":31},"Patrick Houthuizen, MD, PhD",{"facility":78,"status":58,"city":79,"state":80,"zip":81,"country":62,"countryCode":63,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Maasstad Hospital","Rotterdam","South Holland","3079DZ",{"type":65,"coordinates":83},[84,85],4.47917,51.9225,{"lat":85,"lon":84},[88,89],{"name":72,"role":49,"phone":73,"phoneExt":31,"email":74},{"name":90,"role":49,"phone":31,"phoneExt":31,"email":31},"Willem van Dockum, MD, PhD",{"facility":5,"status":58,"city":92,"state":93,"zip":94,"country":62,"countryCode":63,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Nieuwegein","Utrecht","3435 CM",{"type":65,"coordinates":96},[97,98],5.08056,52.02917,{"lat":98,"lon":97},[101,102],{"name":72,"role":49,"phone":73,"phoneExt":31,"email":74},{"name":103,"role":49,"phone":31,"phoneExt":31,"email":31},"Martin J Swaans, MD, PhD",{"facility":46,"status":105,"city":93,"state":93,"zip":106,"country":62,"countryCode":63,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"NOT_YET_RECRUITING","3584X",{"type":65,"coordinates":108},[109,110],5.12222,52.09083,{"lat":110,"lon":109},[113,114,116],{"name":72,"role":49,"phone":73,"phoneExt":31,"email":74},{"name":115,"role":49,"phone":31,"phoneExt":31,"email":31},"Michiel Voskuil, MD, PhD",{"name":117,"role":49,"phone":31,"phoneExt":31,"email":31},"Firdaus Mohamed Hoesein, MD, PhD",{"type":43,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Martin J. Swaans","Principal investigator",[122,124],{"name":123,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":46,"class":6},"100434595","safety-and-cost-efficincy-of-new-imaging-techniques-in-patients-suspected-of-coronary-artery-disease-100434595",false,"NCT04939207","Safety and Cost-efficiëncy of New Imaging Techniques in Patients Suspected of Coronary Artery Disease","Improving the Cost-effectiveness of Coronary Artery Disease Diagnosis","iCORONARY","Inclusion Criteria:\n\n* The subject is willing and able to provide informed consent and adhere to study rules and regulations and follow-up\n* The subject is clinically suspected of having (recurrent) angina pectoris or an equivalent and suspected coronary artery disease, based on symptoms and signs, history, clinical examination and baseline diagnostic testing (e.g. ECG recording and laboratory tests) as described in the 2019 ESC guideline on chronic coronary syndromes.\n* The subject has had ≥64 multidetector row coronary CTA or will undergo coronary CTA as part of usual care deemed by the treating physician with ≥64 multidetector row coronary CTA.\n\nExclusion Criteria:\n\n* The subject is suffering from unstable angina pectoris.\n* The subject is suffering from decompensated congestive cardiac failure.\n* The subject is suffering from a known non-ischemic cardiomyopathy.\n* The subject has a history of PCI or CABG.\n* The subject has had pacemaker or internal defibrillator leads implanted.\n* The subject has a prosthetic heart valve.\n* There is a severe language barrier.\n* The subject participates in any other clinical trial that interferes with the current study.\n* Clinical condition prohibiting subsequent interventional therapy as indicated by the results of the imaging procedures.\n* The subject is or might be pregnant.\n* The subject does not comply or is not able to comply to the imaging guidelines for the performance and acquisition of CCTA by the Society of Cardiac Computed Tomography (SCCT), including:\n\n  * The subject is suffering from a cardiac rhythm other than sinus rhythm.\n  * The subject is morbidly obese (Body Mass Index (BMI) \\> 40).\n  * The subject is not able to sustain a breath-hold for 25 seconds.\n  * The subject is unable to remain in supine position for at least 30 minutes.\n  * The subject has known allergies to or contra-indications to receiving an iodinated contrast agent. Contraindications to receiving an iodinated contrast agent: Glomerular Filtration Rate (GFR) \\\u003C 45 ml\u002Fmin\u002F1,73m2 and if the subject is diabetic or has at least two risk factors for developing contrast induced renal failure a GFR \\\u003C 60 ml\u002Fmin\u002F1,73m2.","ALL","18 Years",{"count":136,"type":137},825,"ESTIMATED","INTERVENTIONAL",[140],"NA","Yearly, 180 000 patients in the Netherlands are referred to a cardiologist with symptoms suspected of coronary artery disease (CAD). To assess this, multiple diagnostic tests are available. Non-invasive imaging tests, such as coronary CT-scan, are safe, relatively cheap and can effectively rule-out CAD. However, when CAD is present, coronary CT-scan cannot assess the restriction in blood flow caused by the stenosis. Cardiac angiography with invasive blood flow measurements is required to assess this restriction in blood flow. This is an invasive test, more expensive than CT and it is accompanied by certain risks.\n\nMost patients in whom CAD is present do not need treatment, and would therefore benefit from non-invasive diagnostic tests. To reduce the number of unnecessary cardiac angiography with flow measurements, new imaging techniques have been developed. These techniques use CT- or angiographic images to calculate the restriction in coronary blood flow and determine the need for treatment. This study is designed to assess the safety and efficacy of these techniques when used as an addition to coronary CT-scan.\n\nSubjects are eligible if their CT-scan indicates possibly significant CAD. To determine need for treatment of a subject's CAD, the investigators will randomize subjects in three arms. One arm consists of additional CT-derived calculation of coronary blood flow, one arm consists of angiography-derived calculation of coronary blood flow and one arm consists of standard care, coronary angiography and invasive coronary blood flow measurements. After these tests, subjects are treated and followed according to routine care guidelines. Additionally, subjects are requested to complete 5 questionnaires in a 12 month follow-up period.\n\nThe investigators expect that the total number of invasive cardiac angiographies with additional blood flow measurements can be reduced by half with the use of new imaging techniques. The investigators expect that this will lead to a reduction in healthcare costs, complications and a lower burden of diagnostic tests for patients. The investigators do not expect a difference in primary endpoints between the study groups.",[143],"Coronary Artery Disease",[145,146,147,148,149,150,151],"Coronary artery disease","Angina pectoris","Coronary arteriosclerosis","CT scan","Cardiac catheterization","Coronary angiography","Myocardial fractional flow reserve","2024-11-27",{"date":154,"type":155},"2024-12-02","ACTUAL",{"date":157,"type":155},"2022-03-22",{"date":159,"type":137},"2025-04-01",{"name":5,"class":6},4]