[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588722":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":34,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Grey zone patients",null,"Patients with caIMR values between 20 and 30 can be enrolled in this group, a total of 254 patients of this type will be enrolled in the study.The binary classification performance of caIMR will be validated based on differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes.",[13],"Device: caIMR",{"label":15,"type":10,"description":16,"interventionNames":17},"Diffuse disease patients.","Patients with diffuse coronary disease and less than 50% stenosis can be enrolled in this group, a total of 254 patients of this type will be enrolled in the study. CaIMR will be assessed in these patients, and its binary classification performance will be validated based on differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","caIMR","caIMR will be measured by pressure sensors which are produced by Suzhou Rainmed Medical Technology Co., Ltd.\n\ncaIMR is calculated based on angiography images and Hyperemic Pa estimated from resting Pa according to prespecified equation",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Dong Huang, Doctor","CONTACT","+8618124009136","huang.dong@zs-hospital.sh.cn",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Ge Junbo","Coordinating Investigator",[35],{"name":36,"class":37},"RainMed Medical Group","INDUSTRY","100588722","a-multi-center-real-world-clinical-trial-of-caimr-on-two-specific-kinds-of-patients-100588722",false,"NCT06945094","A Multi-center, Real-World Clinical Trial of caIMR on Two Specific Kinds of Patients.","A Multi-center, Real-World Clinical Trial on Assessment of Microcirculatory Status Using Online Coronary Angiography-Derived Index of Microcirculatory Resistance (caIMR) (Flash V)","FlashV","Inclusion Criteria:\n\n1. Age between 18 and 80 years, regardless of gender;\n2. Diagnosed with stable angina, unstable angina, or suspected myocardial ischemia;\n3. targeted vessel stenosis \\\u003C 50% and caIMR values between 20 and 30; or\n\n(3) Targeted vessel stenosis \\\u003C 50%, but with lesion length \\> 20 mm and caFFR \\> 0.8, representing diffuse disease.\n\nExclusion Criteria:\n\n1. Previously undergone percutaneous coronary intervention (PCI);\n2. History of heart failure or myocardial infarction;\n3. Acute myocardial infarction;\n4. Primary or secondary cardiomyopathy;\n5. Primary or secondary severe valvular heart disease;\n6. Severe systemic infections;\n7. Malignant cachectic diseases and an estimated survival of less than one year;\n8. Patients who are currently participating in other clinical trials involving drugs or devices and have not yet reached the primary endpoint of those trials;\n9. Patients whom the investigator deems to have other conditions that make them unsuitable for participation in the clinical trial.","ALL","18 Years","80 Years",{"count":50,"type":51},508,"ESTIMATED","OBSERVATIONAL","The coronary angiography-derived index of microcirculatory resistance (caIMR) can be used to provide a binary assessment whether patients（with stable angina, unstable angina, suspected myocardial ischemia, or coronary artery stenosis of less than 50%, and without cardiomyopathy or obstructive epicardial coronary artery disease） have microcirculatory dysfunction, using a cutoff value of 25.\n\nThis study aims to evaluate the binary classification performance of caIMR in two specific groups of patients: (1) those with caIMR values between 20 and 30, and (2) those with diffuse disease. We will do this by looking at differences in their Seattle Angina Questionnaire (SAQ) scores and their health outcomes over a three-year period.",[55,56,57,58],"Coronary Microvascular Dysfunction (CMD)","Stable Angina Pectoris","Unstable Angina Pectoris","Myocardial Ischemia, Angina Pectoris",[60,61,62,63,64],"Hemodynamics","Computational fluid dynamics","Angiography-derived IMR","coronary microvascular dysfunction","stable and unstable angina","NOT_YET_RECRUITING","2025-04-24",{"date":68,"type":69},"2025-04-27","ACTUAL",{"date":71,"type":51},"2025-07-01",{"date":73,"type":51},"2029-12-30",{"name":32,"class":6}]