[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614975":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":158,"collaborators":26,"id":160,"slug":161,"hasResults":162,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":26,"eligibilityCriteria":166,"healthyVolunteers":162,"sex":167,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":26,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":185,"overallStatus":92,"whyStopped":26,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Fundación EPIC","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CT-guide calcium modification strategy","EXPERIMENTAL","Pre-procedural CT will be used to determine lesion characteristics.",[13],"Device: CT(Computed Tomography) guided Percutaneous Coronary Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"IVUS-guide calcium modification strategy","ACTIVE_COMPARATOR","Pre-procedural IVUS will be used to determine lesion characteristics.",[19],"Device: IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","CT(Computed Tomography) guided Percutaneous Coronary Intervention","CT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention","IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"CAROLINA FOCELLA","CONTACT","001 917 753 6695","cfocella@crf.org",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":39},"CARLOS COLLET, MD,PhD","carloscollet@gmail.com",[41,55,65,75,84,90,102,110,119,129,137,142,150],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":26},"Bringham and Women's Hospital","NOT_YET_RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.05977,42.35843,{"lat":53,"lon":52},{"facility":56,"status":43,"city":57,"state":58,"zip":59,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":26},"Minneapolis Heart Institute","Minneapolis","Minnesota","55407",{"type":50,"coordinates":61},[62,63],-93.26384,44.97997,{"lat":63,"lon":62},{"facility":66,"status":43,"city":67,"state":68,"zip":69,"country":47,"countryCode":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":26},"HACKENSACK MERIDIAN HEALTH, Inc","Jersey City","New Jersey","08837",{"type":50,"coordinates":71},[72,73],-74.07764,40.72816,{"lat":73,"lon":72},{"facility":76,"status":43,"city":77,"state":77,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":26},"Columbia University Irving Medical Center\u002FNewYork-Presbyterian Hospital","New York","10032",{"type":50,"coordinates":80},[81,82],-74.00597,40.71427,{"lat":82,"lon":81},{"facility":85,"status":43,"city":77,"state":77,"zip":86,"country":47,"countryCode":48,"cosmosGeoPoint":87,"geoPoint":89,"contacts":26},"Weill Medical College of Cornell University","14853",{"type":50,"coordinates":88},[81,82],{"lat":82,"lon":81},{"facility":91,"status":92,"city":93,"state":26,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":26},"Hospital Universitari Vall Hebron","RECRUITING","Barcelona","08035","Spain","ES",{"type":50,"coordinates":98},[99,100],2.15899,41.38879,{"lat":100,"lon":99},{"facility":103,"status":92,"city":104,"state":26,"zip":26,"country":95,"countryCode":96,"cosmosGeoPoint":105,"geoPoint":109,"contacts":26},"Hospital Universitario de Leon","León",{"type":50,"coordinates":106},[107,108],-5.57032,42.60003,{"lat":108,"lon":107},{"facility":111,"status":92,"city":112,"state":26,"zip":113,"country":95,"countryCode":96,"cosmosGeoPoint":114,"geoPoint":118,"contacts":26},"Hospital Universitario La Paz","Madrid","28046",{"type":50,"coordinates":115},[116,117],-3.70256,40.4165,{"lat":117,"lon":116},{"facility":120,"status":43,"city":121,"state":26,"zip":26,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":26},"University Hospitals of Leicester NHS Trust","Leicester","United Kingdom","UK",{"type":50,"coordinates":125},[126,127],-1.13169,52.6386,{"lat":127,"lon":126},{"facility":130,"status":43,"city":131,"state":26,"zip":26,"country":122,"countryCode":123,"cosmosGeoPoint":132,"geoPoint":136,"contacts":26},"St Bartholomew's Hospital (Barts Health NHS Trust)","London",{"type":50,"coordinates":133},[134,135],-0.12574,51.50853,{"lat":135,"lon":134},{"facility":138,"status":43,"city":131,"state":26,"zip":26,"country":122,"countryCode":123,"cosmosGeoPoint":139,"geoPoint":141,"contacts":26},"St George's University Hospitals NHS Foundations Trust",{"type":50,"coordinates":140},[134,135],{"lat":135,"lon":134},{"facility":143,"status":43,"city":144,"state":26,"zip":26,"country":122,"countryCode":123,"cosmosGeoPoint":145,"geoPoint":149,"contacts":26},"Newcastle Hospitals NHS Foundations Trust","Newcastle",{"type":50,"coordinates":146},[147,148],-5.88979,54.21804,{"lat":148,"lon":147},{"facility":151,"status":43,"city":152,"state":26,"zip":26,"country":122,"countryCode":123,"cosmosGeoPoint":153,"geoPoint":157,"contacts":26},"John Radcliffe Hospital, Oxford","Oxford",{"type":50,"coordinates":154},[155,156],-1.25596,51.75222,{"lat":156,"lon":155},{"type":159,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100614975","a-prospective-multicenter-randomized-controlled-trial-to-investigate-the-value-of-coronary-ct-angiography-in-the-understanding-and-management-of-coronary-calcium-the-optimal-trial-100614975",false,"NCT07286578","A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)","A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium","Inclusion Criteria:\n\n* The subject must be at least 18 years of age and younger than 85 years old\n* Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression\\>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score\\>140.\n* All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm\n* Subject must provide written informed consent before any study-related procedure\n\nExclusion Criteria:\n\n* STEMI as the clinical presentation.\n* Uncontrolled or recurrent ventricular tachycardia.\n* Hemodynamic instability.\n* Hemodialysis or peritoneal dialysis.\n* Left main coronary artery stenosis \\> 50%\n* Atrial fibrillation, flutter, or arrhythmias during CT acquisition.\n* Previous PCI in the target vessel or CABG.\n* BMI ≥ 40 kg\u002Fm2\n* Insufficient CT quality assessed by the Core lab.\n* Comorbidity with life expectancy ≤ 2 years.\n* Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.\n* The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.\n* The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.\n* The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest\u002Fmediastinum.\n* Subject has a platelet count \\\u003C100,000 cells\u002Fmm3 or \\>700,000 cells\u002Fmm3.\n* The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.\n* The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy \\\u003C2 years for any non-cardiac cause.\n* Subject is currently participating in another investigational drug or device clinical study.\n* Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n* Unable to provide written informed consent (IC).","ALL","18 Years","85 Years",{"count":171,"type":172},700,"ESTIMATED","INTERVENTIONAL",[175],"NA","The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.",[178,179,180,181,182,183,184],"Cardiovascular Diseases","Myocardial Ischemia","Heart Diseases","Arteriosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Coronary Artery Disease",[186,187],"IVUS","CT","2026-02-09",{"date":190,"type":191},"2026-02-10","ACTUAL",{"date":193,"type":191},"2025-12-22",{"date":195,"type":172},"2030-01-01",{"name":5,"class":6},13]