[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593291":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":43,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":25,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":25,"enrollmentInfo":60,"targetDuration":25,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MCCE-first arm","EXPERIMENTAL","MCCE will be performed for individuals randomized to MCCE arm within the same hospitalization of ACS diagnosis. The MCCE used in this study is the magnetically controlled capsule endoscopy (MCE, AnPx USA) which is a capsule measuring 28x12mm, and contains a permanent magnet inside its dome. Images are captured and recorded at 2 frames\u002Fs. Before the MCCE procedure, subjects will be fasted for 8 hours. Capsule will be swallowed with 10ml of clear liquid. During the MCCE examination, subjects will be asked to drink 500 to 1000ml water on demand. Once inside the stomach, the capsule will be navigated via an external magnetic guidance system to obtain a full view of the stomach. After the gastric examination, the subject wears a portable image recorder for images of duodenum and the rest of the small bowel for about 4 hours",[13],"Procedure: Magnetically Controlled Capsule Endoscopy (MCCE)",{"label":15,"type":10,"description":16,"interventionNames":17},"EGD-first arm","Conventional EGD with intravenous sedation will be performed for individuals randomized to EGD arm within the same hospitalization of ACS diagnosis by an experienced endoscopist. Similar MLD and Forest ulcer grading will be applied as in MCCE arm. Endoscopic therapeutic procedures will be performed at endoscopist's discretion.",[18],"Procedure: Esophageal-gastro-Duodenoscopy (EGD)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Magnetically Controlled Capsule Endoscopy (MCCE)",". The MCCE used in this study is the magnetically controlled capsule endoscopy (MCE, AnPx USA) which is a capsule measuring 28x12mm, and contains a permanent magnet inside its dome. Images are captured and recorded at 2 frames\u002Fs",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Esophageal-gastro-Duodenoscopy (EGD)","Esophageal-gastro-Duodenoscopy (EGD) is commonly performed to look for source of bleeding in patients with anaemia. However, from our own analysis and from retrospective studies of EGD in patients with ACS, EGD finding was normal or non-significant in 20-80% patients14-16. Moreover, EGD was associated with non-negligible periprocedural risks in patients with ACS, including death directly attributed to EGD (9.1%; 95% CI 7.6-10.9%), hypotension (24.1%; 95% CI 17.0-32.9%), arrhythmias (8.3%; 95% CI 4.5-15.1%) and recurrent ACS (6.5%; 95% CI 3.2-12.8%)",[15],[31],{"facility":32,"status":25,"city":33,"state":34,"zip":35,"country":33,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":25},"Prince of Wales Hospital","Hong Kong","Shatin","0000","HK",{"type":38,"coordinates":39},"Point",[40,41],114.17469,22.27832,{"lat":41,"lon":40},{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","GuangMing Tan","Assistant professor",[48],{"name":49,"class":50},"Health and Medical Research Fund","OTHER_GOV","100593291","the-mcce-vs-egd-trial-100593291",false,"NCT07004530","the MCCE vs EGD Trial","Magnetically Controlled Capsule Endoscopy vs Esophago-gastro-Duodenoscopy as The Initial Investigation for Anaemia in Patients With Acute Coronary Syndrome (the MCCE vs EGD Trial) - a Single Centre Randomized Study","Inclusion Criteria:\n\nsubjects are patients older than 18 years old with:\n\n1. the diagnosis of ACS as defined by symptoms of chest pain or shortness-of-breath, abnormal electrocardiogram and positive enzyme, requiring coronary intervention\n2. new-onset anaemia as defined by Hb\\\u003C11 g\u002FdL on admission blood taking\n\nExclusion Criteria:\n\n1. History of active haematological disease including hemoglobinopathies such as thalassemia, Myelodysplastic syndromes, haematological malignancy, aplastic anaemia, or autoimmune haemolytic anaemia.\n2. Patients with known active gastrointestinal malignancy.\n3. Contraindications for CE: suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, presence of gastrointestinal obstruction symptoms such as pain or dysphagia; inoperative conditions or refusal to undergo abdominal surgery if required; history of laparotomy, gastric or bowel surgery; presence of metallic implants that is not MRI conditional.\n4. Contraindications for EGD: Possible gastrointestinal perforation, medically unstable patients, patient with known pharyngeal diverticulum, and patients with recent head and neck trauma.\n5. Inability to take 1-month DAPT such as non-deferrable surgery within 1 months, severe allergy or hypersensitivity reaction to aspirin or P2Y12 inhibitors, or patients in whom 1 months DAPT is not indicated.\n6. Patients whose life-expectancy is less than 6 months.\n7. Patients who are pregnant or lactating.\n8. Patients who are unable to give informed consent.\n9. Patients who are in active heart failure or fluid-overload state.\n10. Patients who have chronic renal failure as defined by estimated glomerular filtration rate \\\u003C15 ml\u002Fmin\u002F1.73m2.","ALL","19 Years",{"count":61,"type":62},238,"ESTIMATED","INTERVENTIONAL",[65],"NA","Anaemia is common in patients with acute coronary syndrome (ACS) and is associated with significant recurrent bleeding risk and major adverse cardiovascular event (MACE). Esophageal-gastro-Duodenoscopy (EGD) is commonly used as an initial investigation for anaemia but is often non-diagnostic. Magnetically Controlled Capsule Endoscopy (MCCE) being less invasive and with comparable diagnostic accuracy as EGD, might be used as an alternative initial investigation for anaemia in patients with ACS.",[68,69],"Anaemia","Acute Coronary Syndrome",[71,72],"Capsule Endoscopy","Esophago-gastro-Duodenoscopy","NOT_YET_RECRUITING","2025-05-27",{"date":76,"type":77},"2025-06-04","ACTUAL",{"date":79,"type":62},"2025-09-24",{"date":81,"type":62},"2027-11-24",{"name":5,"class":6},1]