[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06112418":3,"trial-entities:NCT06112418":1310,"trial-summary:NCT06112418":1315},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":66,"locations":69,"central_contacts":1282,"overall_officials":1290,"references":1298,"see_also_links":1306},"NCT06112418","202302CPC","A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events","A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events","RECRUITING","2029-03-05","2026-08","2026-08-19","2024-03-06","Cleerly, Inc.","INDUSTRY",true,"TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.","Cardiovascular disease (CVD) persists as the leading cause of morbidity and mortality worldwide at high societal cost. The current primary CVD prevention strategy relies upon risk stratification using population health markers such as age, sex, diabetes, hypertension, dyslipidemia and tobacco use, with preventive therapy intensified in higher risk strata. Since these risk factors are indirect surrogate markers of the underlying disease, atherosclerosis, this strategy leads to treatment of individuals with risk factors who do not have atherosclerosis and failure to treat those with significant atherosclerosis who lack risk factors. The current strategy also cannot determine which individuals are inadequately treated despite effective risk factor management (residual risk). With the current approach, the CV death rate is trending upward in the US despite evidence that screening asymptomatic patients reduces CV events and the widespread availability of effective preventive therapies.\n\nThis randomized, controlled, pragmatic trial is designed to address the unmet need for better strategies to identify asymptomatic individuals at increased risk for CV events due to atherosclerosis and to personalize their treatment based on CV risk estimates using coronary artery disease (CAD) visualization and quantification.\n\nThis study enrolls patients without known symptoms of ASCVD but who are at increased risk for ASCVD due to their age and having diabetes, prediabetes or metabolic syndrome and tests the hypothesis that a CAD Staging System-based care strategy reduces CV events compared with risk factor-based care. The Cleerly CAD Staging System incorporates imaging-based evaluation for coronary atherosclerosis, algorithm-supported pharmacotherapy and personalized education about their CAD.",[19,20,21],"Diabetes Mellitus, Type 2","PreDiabetes","Metabolic Syndrome",[],"INTERVENTIONAL","PREVENTION",[26],"NA",{"count":28,"type":29},7500,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","The Cleerly CAD Staging System","The Cleerly CAD Staging System is software that utilizes a proprietary algorithm to identify CAD, stage the severity of CAD when present, and generate a prognostic risk score to inform treatment decisions that support CV disease prevention.",[36],"Cleerly Stage-Based Care",[38],{"measure":39,"description":40,"timeFrame":41},"The primary objective is to compare Cleerly stage-based care with risk factor-based care on the risk of CV events.","The primary endpoint is total (first and subsequent) events for the composite endpoint of CV death, myocardial infarction (MI), ischemic stroke, acute limb ischemia, clinically driven arterial revascularization, and hospitalization or urgent visit for heart failure.","Through study completion- an average of 3.5 years",[43,46,48,50,52],{"measure":44,"description":45,"timeFrame":41},"The secondary objective is to compare Cleerly CAD stage-based care with risk factor-based care on other clinical events of CV and renal morbidity and mortality.","The secondary endpoints are time from randomization to first occurence of an event in the primary efficacy endpoint.",{"measure":44,"description":47,"timeFrame":41},"The secondary endpoints are total occurences after randomization of the primary efficacy endpoing, kidney failure, sustained estimated glomerular filtration rate (eGFR) decrease \\>40% from baseline, and death from renal causes.",{"measure":44,"description":49,"timeFrame":41},"The secondary endpoints are first and total occurrences after randomization of coronary death, MI, and urgent coronary revascularization.",{"measure":44,"description":51,"timeFrame":41},"The secondary endpoints are time from randomization to first occurrence of MI or ischemic stroke.",{"measure":44,"description":53,"timeFrame":41},"The secondary endpoints are time from randomization to all-cause death.","ALL","55 Years",null,{"inclusion":58,"exclusion":64,"raw_text":65},[59,60,61,62,63],"Body mass index ≥ 27 kg\u002Fm2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches)","Fasting triglycerides ≥ 150 mg\u002FdL (1.7 mmol\u002FL) or treated hypertriglyceridemia","HDL-cholesterol (HDL-C) \\\u003C 40 mg\u002FdL (1.03 mmol\u002FL) in men, \\\u003C50 mg\u002FdL (1.29 mmol\u002FL) in women or treatment for this lipid abnormality","Systolic blood pressure (BP) ≥ 130 and\u002For diastolic BP≥ 85 mm Hg and\u002For treated hypertension","Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or HbA1c ≥ 5.7% 4. Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group",[],"Inclusion Criteria:\n\n1. Provided electronic or written informed consent\n2. Men \\> 55, women \\> 65 years of age\n3. Type 2 diabetes mellitus requiring pharmacologic therapy, prediabetes (most recent HbA1c 5.7 to 6.4% and\u002For fasting glucose 100-125 mg\u002FdL \\[5.6-6.9 mmol\u002FL\\]) and\u002For metabolic syndrome. Metabolic syndrome is defined as \\> 3 of the following criteria (International Diabetes Federation 2006):\n\n   * Body mass index ≥ 27 kg\u002Fm2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches)\n   * Fasting triglycerides ≥ 150 mg\u002FdL (1.7 mmol\u002FL) or treated hypertriglyceridemia\n   * HDL-cholesterol (HDL-C) \\\u003C 40 mg\u002FdL (1.03 mmol\u002FL) in men, \\\u003C50 mg\u002FdL (1.29 mmol\u002FL) in women or treatment for this lipid abnormality\n   * Systolic blood pressure (BP) ≥ 130 and\u002For diastolic BP≥ 85 mm Hg and\u002For treated hypertension\n   * Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or HbA1c ≥ 5.7%\n4. Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group\n\nExclusion Criteria:\n\n1. History of symptomatic CVD defined as prior MI, exertional or unstable angina, ischemic stroke, claudication, arterial revascularization for atherosclerosis or other CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heart failure\n2. Planned arterial revascularization\n3. Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:\n\n   1. eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation (www.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator)\n   2. Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screening laboratory values consistent with untreated hyperthyroidism. Participants with elevated thyroid-stimulating hormone (TSH) may be enrolled but should be referred to their physician for evaluation for treatment.\n   3. Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment\n   4. Weight \\> 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site\n   5. Inability to hold breath for \\> 10 seconds\n   6. Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \\> 80 beats per minute at screening or prior to CCTA)\n   7. Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA\n   8. Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA\n4. Unsuitable as a trial participant in the opinion of the investigator for reasons including significant left main stenosis (e.g. ≥ 70%; site will be notified by Cleerly), other health condition with life expectancy \\\u003C 3 years or being at risk of poor compliance with study procedures (e.g., active substance abuse or untreated mental illness that, in the opinion of the investigator, is likely to adversely affect adherence or retention)",[67,68],"ADULT","OLDER_ADULT",[70,83,93,103,113,124,131,141,151,161,171,181,191,201,211,221,231,241,250,256,263,267,277,287,293,303,313,323,333,343,357,367,378,388,398,408,418,425,434,441,447,454,461,471,481,491,501,512,522,532,542,552,562,572,582,592,602,613,624,634,645,652,663,674,684,695,706,716,727,734,745,755,766,777,784,795,805,816,827,834,845,855,865,875,885,896,903,913,923,933,942,949,960,970,977,986,993,1003,1014,1025,1036,1043,1053,1064,1075,1086,1096,1106,1117,1127,1137,1147,1154,1161,1168,1178,1188,1198,1208,1218,1228,1240,1251,1262,1272],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":80},"Chandler Clinical Trials","Chandler","Arizona","85224","United States",[77],{"name":78,"role":79},"Muhammad Salim, MD","CONTACT",{"lat":81,"lon":82},33.30616,-111.84125,{"facility":84,"status":8,"city":85,"state":73,"zip":86,"country":75,"contacts":87,"geoPoint":90},"Scottsdale Clinical Trials","Scottsdale","85260",[88],{"name":89,"role":79},"Todd Dreitzler, MD",{"lat":91,"lon":92},33.50921,-111.89903,{"facility":94,"status":8,"city":95,"state":73,"zip":96,"country":75,"contacts":97,"geoPoint":100},"Sun City Research","Sun City","85381",[98],{"name":99,"role":79},"Juan Rodriguez, MD",{"lat":101,"lon":102},33.59754,-112.27182,{"facility":104,"status":8,"city":105,"state":73,"zip":106,"country":75,"contacts":107,"geoPoint":110},"Noble Clinical Research","Tucson","85704",[108],{"name":109,"role":79},"Roxana Rodriguez, MD",{"lat":111,"lon":112},32.22174,-110.92648,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":75,"contacts":118,"geoPoint":121},"Cardiovascular Research Foundation of Southern California","Beverly Hills","California","90210",[119],{"name":120,"role":79},"Ronald P. Karlsberg, MD",{"lat":122,"lon":123},34.07362,-118.40036,{"facility":125,"status":8,"city":115,"state":116,"zip":126,"country":75,"contacts":127,"geoPoint":130},"Amicis Research: Beverly Hills","90211",[128],{"name":129,"role":79},"Michael Levine, MD",{"lat":122,"lon":123},{"facility":132,"status":8,"city":133,"state":116,"zip":134,"country":75,"contacts":135,"geoPoint":138},"Valiance Clinical Research - Canoga Park","Canoga Park","91303",[136],{"name":137,"role":79},"Rami Shaarawy",{"lat":139,"lon":140},34.20112,-118.59814,{"facility":142,"status":8,"city":143,"state":116,"zip":144,"country":75,"contacts":145,"geoPoint":148},"Cardiovascular Institute of San Diego","Chula Vista","91911",[146],{"name":147,"role":79},"Milind D. Parikh, MD",{"lat":149,"lon":150},32.64005,-117.0842,{"facility":152,"status":8,"city":153,"state":116,"zip":154,"country":75,"contacts":155,"geoPoint":158},"Amicis Research: Granada Hills","Granada Hills","91324",[156],{"name":157,"role":79},"Pascal Dabel, MD",{"lat":159,"lon":160},34.26472,-118.52314,{"facility":162,"status":8,"city":163,"state":116,"zip":164,"country":75,"contacts":165,"geoPoint":168},"Valiance Clinical Research: Huntington Park","Huntington Park","90255",[166],{"name":167,"role":79},"Philip Kim, MD",{"lat":169,"lon":170},33.98168,-118.22507,{"facility":172,"status":8,"city":173,"state":116,"zip":174,"country":75,"contacts":175,"geoPoint":178},"HALO Diagnostics","Indian Wells","92210",[176],{"name":177,"role":79},"John F. Feller, MD",{"lat":179,"lon":180},33.71791,-116.34311,{"facility":182,"status":8,"city":183,"state":116,"zip":184,"country":75,"contacts":185,"geoPoint":188},"Scripps Health","La Jolla","92037",[186],{"name":187,"role":79},"Elizabeth Epstein, MD",{"lat":189,"lon":190},32.84727,-117.2742,{"facility":192,"status":8,"city":193,"state":116,"zip":194,"country":75,"contacts":195,"geoPoint":198},"Chemidox Clinical Trials","Lancaster","93534",[196],{"name":197,"role":79},"Pamela Dewar-DeSilva, MD",{"lat":199,"lon":200},34.69804,-118.13674,{"facility":202,"status":8,"city":203,"state":116,"zip":204,"country":75,"contacts":205,"geoPoint":208},"Loma Linda University Health","Loma Linda","92354",[206],{"name":207,"role":79},"Purvi Parwani, MD",{"lat":209,"lon":210},34.04835,-117.26115,{"facility":212,"status":8,"city":213,"state":116,"zip":214,"country":75,"contacts":215,"geoPoint":218},"Long Beach Research Institute","Long Beach","90805",[216],{"name":217,"role":79},"Ashley Duzik, MD",{"lat":219,"lon":220},33.76696,-118.18923,{"facility":222,"status":8,"city":223,"state":116,"zip":224,"country":75,"contacts":225,"geoPoint":228},"Ace Research Institute - Monterey Park","Monterey Park","91754",[226],{"name":227,"role":79},"Yu-Hsiang Sam Lee, MD",{"lat":229,"lon":230},34.06251,-118.12285,{"facility":232,"status":8,"city":233,"state":116,"zip":234,"country":75,"contacts":235,"geoPoint":238},"Amicis Research: Newhall","Newhall","91321",[236],{"name":237,"role":79},"Thuong Vo, MD",{"lat":239,"lon":240},34.38472,-118.53092,{"facility":242,"status":8,"city":243,"state":116,"zip":154,"country":75,"contacts":244,"geoPoint":247},"Ace Research Institute: Northridge","Northridge",[245],{"name":246,"role":79},"Richard Park, MD",{"lat":248,"lon":249},34.22834,-118.53675,{"facility":251,"status":8,"city":243,"state":116,"zip":154,"country":75,"contacts":252,"geoPoint":255},"Amicis Research: Northridge",[253],{"name":254,"role":79},"Nana Barseghian, MD",{"lat":248,"lon":249},{"facility":257,"status":8,"city":243,"state":116,"zip":258,"country":75,"contacts":259,"geoPoint":262},"Ace Research Institute: Northridge #2","91325",[260],{"name":261,"role":79},"William Y. Josephson, MD",{"lat":248,"lon":249},{"facility":264,"status":265,"city":243,"state":116,"zip":258,"country":75,"geoPoint":266},"Northridge Clinical Trials","ACTIVE_NOT_RECRUITING",{"lat":248,"lon":249},{"facility":268,"status":8,"city":269,"state":116,"zip":270,"country":75,"contacts":271,"geoPoint":274},"University of California- Irvine","Orange","92868",[272],{"name":273,"role":79},"Ailin Barseghian El-Farra, MD",{"lat":275,"lon":276},33.78779,-117.85311,{"facility":278,"status":8,"city":279,"state":116,"zip":280,"country":75,"contacts":281,"geoPoint":284},"Stanford Health Care","Palo Alto","94304",[282],{"name":283,"role":79},"Sandra Tsai, MD",{"lat":285,"lon":286},37.44188,-122.14302,{"facility":288,"status":8,"city":279,"state":116,"zip":280,"country":75,"contacts":289,"geoPoint":292},"VA Palo Alto",[290],{"name":291,"role":79},"Shriram Nallamshetty, MD",{"lat":285,"lon":286},{"facility":294,"status":8,"city":295,"state":116,"zip":296,"country":75,"contacts":297,"geoPoint":300},"Amicis Research: San Fernando","San Fernando","91306",[298],{"name":299,"role":79},"Farid Yasharpour, MD",{"lat":301,"lon":302},34.28195,-118.43897,{"facility":304,"status":8,"city":305,"state":116,"zip":306,"country":75,"contacts":307,"geoPoint":310},"Valiance Clinical Research - Tarzana","Tarzana","91356",[308],{"name":309,"role":79},"Harpreet Singh, MD",{"lat":311,"lon":312},34.17334,-118.55397,{"facility":314,"status":8,"city":315,"state":116,"zip":316,"country":75,"contacts":317,"geoPoint":320},"Lundquist Institute for Biomedical Innovation at Harbor - UCLA Medical Center","Torrance","90502",[318],{"name":319,"role":79},"Suvasini Lakshmanan, MD",{"lat":321,"lon":322},33.83585,-118.34063,{"facility":324,"status":8,"city":325,"state":116,"zip":326,"country":75,"contacts":327,"geoPoint":330},"Amicis Research: Valencia","Valencia","91355",[328],{"name":329,"role":79},"Dennis Lewis, MD",{"lat":331,"lon":332},34.44361,-118.60953,{"facility":334,"status":8,"city":335,"state":116,"zip":336,"country":75,"contacts":337,"geoPoint":340},"Concierge Clinical Trials","Valley Village","91607",[338],{"name":339,"role":79},"Ruth Espinoza, MD",{"lat":341,"lon":342},34.16488,-118.3965,{"facility":344,"status":8,"city":345,"state":346,"zip":347,"country":75,"contacts":348,"geoPoint":354},"University of Colorado","Aurora","Colorado","80045",[349,351],{"name":350,"role":79},"Steve Simon",{"name":352,"role":353},"Steve Simon, MD","PRINCIPAL_INVESTIGATOR",{"lat":355,"lon":356},39.72943,-104.83192,{"facility":358,"status":8,"city":359,"state":346,"zip":360,"country":75,"contacts":361,"geoPoint":364},"St. Josephs (Intermountain Healthcare)","Denver","80218",[362],{"name":363,"role":79},"Christopher Angus, MD",{"lat":365,"lon":366},39.73915,-104.9847,{"facility":368,"status":8,"city":369,"state":370,"zip":371,"country":75,"contacts":372,"geoPoint":375},"Flourish Medical Research","Boca Raton","Florida","33434",[373],{"name":374,"role":79},"Michael Hafran, MD",{"lat":376,"lon":377},26.35869,-80.0831,{"facility":379,"status":8,"city":380,"state":370,"zip":381,"country":75,"contacts":382,"geoPoint":385},"Apex Research","Cross City","32628",[383],{"name":384,"role":79},"Tamir Salmani, MD",{"lat":386,"lon":387},29.63465,-83.12694,{"facility":389,"status":8,"city":390,"state":370,"zip":391,"country":75,"contacts":392,"geoPoint":395},"Evolution Research Center","Hialeah","33012",[393],{"name":394,"role":79},"Riquel Gonzalez, MD",{"lat":396,"lon":397},25.8576,-80.27811,{"facility":399,"status":8,"city":400,"state":370,"zip":401,"country":75,"contacts":402,"geoPoint":405},"UF Health Jacksonville","Jacksonville","32209",[403],{"name":404,"role":79},"Luis Ortega Paz, MD",{"lat":406,"lon":407},30.33218,-81.65565,{"facility":409,"status":8,"city":410,"state":370,"zip":411,"country":75,"contacts":412,"geoPoint":415},"Fiel Wellness Clinical Research LLC","Miami","33135",[413],{"name":414,"role":79},"Osvaldo Caroma, MD",{"lat":416,"lon":417},25.77427,-80.19366,{"facility":419,"status":8,"city":410,"state":370,"zip":420,"country":75,"contacts":421,"geoPoint":424},"BioPhase Research","33137",[422],{"name":423,"role":79},"Julie Cadet-Plassman, MD",{"lat":416,"lon":417},{"facility":426,"status":8,"city":410,"state":370,"zip":427,"country":75,"contacts":428,"geoPoint":433},"United Clinical Research","33155",[429,431],{"name":430,"role":79},"Teresa B. Alfonso, MD",{"name":432,"role":79},"Alfonso",{"lat":416,"lon":417},{"facility":435,"status":8,"city":410,"state":370,"zip":436,"country":75,"contacts":437,"geoPoint":440},"Atlantis Clinical Research, LLC","33173",[438],{"name":439,"role":79},"Leyvi Alvarado Miranda, MD",{"lat":416,"lon":417},{"facility":442,"status":8,"city":410,"state":370,"zip":436,"country":75,"contacts":443,"geoPoint":446},"Baptist Health Miami Cardiac and Vascular Institute",[444],{"name":445,"role":79},"Jonathan Fialkow, MD",{"lat":416,"lon":417},{"facility":448,"status":8,"city":410,"state":370,"zip":449,"country":75,"contacts":450,"geoPoint":453},"Farma Medical Inc.","33183",[451],{"name":452,"role":79},"Ingrid Fernandez-Milian, MD",{"lat":416,"lon":417},{"facility":455,"status":8,"city":410,"state":370,"zip":456,"country":75,"contacts":457,"geoPoint":460},"New Access Research and Medical Center","33186",[458],{"name":459,"role":79},"Sander Fernandez, MD",{"lat":416,"lon":417},{"facility":462,"status":8,"city":463,"state":370,"zip":464,"country":75,"contacts":465,"geoPoint":468},"Quantum Clinical Trials","Miami Beach","33140",[466],{"name":467,"role":79},"Christopher A. Fayeghi, MD",{"lat":469,"lon":470},25.79065,-80.13005,{"facility":472,"status":8,"city":473,"state":370,"zip":474,"country":75,"contacts":475,"geoPoint":478},"Ascension Sacred Heart","Pensacola","32504",[476],{"name":477,"role":79},"Rohit Amin, MD",{"lat":479,"lon":480},30.42131,-87.21691,{"facility":482,"status":8,"city":483,"state":370,"zip":484,"country":75,"contacts":485,"geoPoint":488},"Clinical Research Center of Florida","Pompano Beach","33060",[486],{"name":487,"role":79},"Howard S. Koch, MD",{"lat":489,"lon":490},26.23786,-80.12477,{"facility":492,"status":8,"city":493,"state":370,"zip":494,"country":75,"contacts":495,"geoPoint":498},"University of South Florida","Tampa","33620",[496],{"name":497,"role":79},"Shone Almeida, MD",{"lat":499,"lon":500},27.94752,-82.45843,{"facility":502,"status":8,"city":503,"state":504,"zip":505,"country":75,"contacts":506,"geoPoint":509},"Aiyan Diabetes Center","Augusta","Georgia","30907",[507],{"name":508,"role":79},"Anthony D. 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Epub 2022 Jan 26.",{"pmid":1304,"type":1301,"citation":1305},"29452348","Clerc OF, Fuchs TA, Stehli J, Benz DC, Grani C, Messerli M, Giannopoulos AA, Buechel RR, Luscher TF, Pazhenkottil AP, Kaufmann PA, Gaemperli O. Non-invasive screening for coronary artery disease in asymptomatic diabetic patients: a systematic review and meta-analysis of randomised controlled trials. Eur Heart J Cardiovasc Imaging. 2018 Aug 1;19(8):838-846. doi: 10.1093\u002Fehjci\u002Fjey014.",[1307],{"label":1308,"url":1309},"World Health Organization - Cardiovascular Diseases","http:\u002F\u002Fwww.who.int\u002Fhealth-topics\u002Fcardiovascular-diseases#tab=tab_1",{"nct_id":4,"conditions":1311,"biomarkers":1314},[21,1312,1313],"Prediabetes","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":1316,"prompt_version":1326},{"design":1317,"status":1318,"heading":1319,"summary":1320,"follow_up":1321,"word_count":1322,"commitments":1323,"compensation":1324,"drugs_mentioned":1325},"This is a randomized, controlled study, meaning participants are assigned by chance to one of two care strategies. It is an open blinded endpoint (PROBE) trial, and plans to enroll 7500 participants.","completed","TRANSFORM Study: Comparing Heart Disease Prevention Strategies","The TRANSFORM study is comparing two ways to prevent heart disease in people at higher risk. It's testing if using the Cleerly CAD Staging System, a software that identifies and stages coronary artery disease (CAD) to guide treatment, is better than the usual care based on risk factors like age and diabetes. This study is for men over 55 and women over 65 who have type 2 diabetes, prediabetes, or metabolic syndrome. The main goal is to see if the Cleerly system can reduce heart-related problems over an average of 3.5 years. The study aims to enroll 7500 participants.","Participants will be followed through study completion, which is an average of 3.5 years.",99,"Not specified in the trial record.","Not stated in the trial record.",[33],"v2"]