[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424919":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":33,"centralContacts":44,"locations":54,"responsibleParty":343,"collaborators":346,"id":389,"slug":390,"hasResults":391,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":391,"sex":397,"minAge":398,"maxAge":24,"enrollmentInfo":399,"targetDuration":24,"studyType":402,"phases":403,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":57,"whyStopped":24,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":425},{"fullName":5,"class":6},"University of Cape Town","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Remote Ischaemic Conditioning (RIC)","ACTIVE_COMPARATOR","Consented STEMI participants presenting \\\u003C 24 hours who are randomised to the RIC protocol, will receive blood pressure cuff inflation by the automated RIC blood pressure device to 20 mmHg above systolic blood pressure for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total. The RIC protocol will be repeated daily for the next 2 days.",[13],"Device: Remote Ischaemic Conditioning (RIC)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham-control","SHAM_COMPARATOR","Consented STEMI participants presenting \\\u003C 24 hours who are randomised to the sham protocol will receive low-pressure cuff inflation to 20 mmHg for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total by a visually identical pneumatic cuff. The sham control protocol will be repeated daily for the next 2 days.",[19],"Device: Sham-control",{"label":21,"type":22,"description":23,"interventionNames":24},"Observational","NO_INTERVENTION","Consented STEMI participants presenting \\> 24 hours but within 72 hours of MI onset will be recruited into the observational arm of the study which will have the same study endpoints as the RCT. These participants will not be randomised or receive any trial intervention.",null,[26,30],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":24},"DEVICE","The RIC protocol will comprise inflation of the automated RIC device to 20 mmHg above systolic blood pressure for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total. The RIC protocol will be repeated daily for the next 2 days.",[9],{"type":27,"name":15,"description":31,"armGroupLabels":32,"otherNames":24},"The sham protocol will comprise low-pressure inflation to 20 mmHg for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total by a visually identical pneumatic cuff used in the active arm. The sham control protocol will be repeated daily for the next 2 days.",[15],[34,37,40,42],{"name":35,"affiliation":5,"role":36},"Mpiko Ntsekhe, PhD","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":36},"Derek Hausenloy, PhD","Hatter Cardiovascular Institute",{"name":41,"affiliation":39,"role":36},"Derek Yellon, PhD",{"name":43,"affiliation":39,"role":36},"Malcolm Walker, PhD",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":24,"email":49},"Kishal Lukhna, MBChB","CONTACT","+27732515380","kishallukhna@gmail.com",{"name":51,"role":47,"phone":52,"phoneExt":24,"email":53},"Sara Giesz","+44(0)20 3447 9888","s.giesz@ucl.ac.uk",[55,78,88,102,112,128,144,162,178,197,211,223,234,249,265,279,289,298,311,324],{"facility":56,"status":57,"city":58,"state":59,"zip":24,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Coast General Teaching Hospital","RECRUITING","Mombasa","Mombasa County","Kenya","KE",{"type":63,"coordinates":64},"Point",[65,66],39.66359,-4.05466,{"lat":66,"lon":65},[69,72,75,76],{"name":70,"role":47,"phone":24,"phoneExt":24,"email":71},"Keiran Mwazo, MBChB","kmwasha@yahoo.com",{"name":73,"role":47,"phone":24,"phoneExt":24,"email":74},"Vickie Mumbo, MBChB","mumbovickie@gmail.com",{"name":70,"role":36,"phone":24,"phoneExt":24,"email":24},{"name":73,"role":77,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"facility":79,"status":57,"city":58,"state":59,"zip":24,"country":60,"countryCode":61,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"Mombasa Hospital",{"type":63,"coordinates":81},[65,66],{"lat":66,"lon":65},[84,87],{"name":85,"role":47,"phone":24,"phoneExt":24,"email":86},"Abdullah A Bajaber, MBChB","baja1930@gmail.com",{"name":85,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":89,"status":57,"city":90,"state":91,"zip":24,"country":60,"countryCode":61,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Kenyatta National Hospital","Nairobi","Nairobi County",{"type":63,"coordinates":93},[94,95],36.81667,-1.28333,{"lat":95,"lon":94},[98,101],{"name":99,"role":47,"phone":24,"phoneExt":24,"email":100},"Elijah Ogola, PhD","Elijah.ogola@uonbi.ac.ke",{"name":99,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":103,"status":57,"city":90,"state":24,"zip":24,"country":60,"countryCode":61,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Nairobi West hospital",{"type":63,"coordinates":105},[94,95],{"lat":95,"lon":94},[108,111],{"name":109,"role":47,"phone":24,"phoneExt":24,"email":110},"Elijah Elijah, PhD","elijah.ogola@uonbi.ac.ke",{"name":109,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":113,"status":57,"city":114,"state":24,"zip":24,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Hospital Central de Mpauto","Maputo","Mozambique","MZ",{"type":63,"coordinates":118},[119,120],32.58322,-25.96553,{"lat":120,"lon":119},[123,126],{"name":124,"role":47,"phone":24,"phoneExt":24,"email":125},"Neusa Jensen, MBCHB, PhD","neusa.jessen@gmail.com",{"name":127,"role":36,"phone":24,"phoneExt":24,"email":24},"Neusa Jensen",{"facility":129,"status":57,"city":130,"state":24,"zip":24,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Hopital Principal de Dakar","Dakar","Senegal","SN",{"type":63,"coordinates":134},[135,136],-17.44406,14.6937,{"lat":136,"lon":135},[139,142],{"name":140,"role":47,"phone":24,"phoneExt":24,"email":141},"Cherif Mboup, MBCHB, PHD","mcmboup@yahoo.fr",{"name":143,"role":36,"phone":24,"phoneExt":24,"email":24},"Cherif Mboup",{"facility":145,"status":57,"city":146,"state":147,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Charlotte Maxeke Hospital","Johannesburg","Gauteng","2193","South Africa","ZA",{"type":63,"coordinates":152},[153,154],28.04363,-26.20227,{"lat":154,"lon":153},[157,161],{"name":158,"role":47,"phone":159,"phoneExt":24,"email":160},"Arthur Mutyab, MBChB","+27724267928","akaggwe@yahoo.com",{"name":158,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":163,"status":57,"city":164,"state":165,"zip":166,"country":149,"countryCode":150,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Wentworth Hospital","Durban","KwaZulu-Natal","4026",{"type":63,"coordinates":168},[169,170],31.0292,-29.8579,{"lat":170,"lon":169},[173,177],{"name":174,"role":47,"phone":175,"phoneExt":24,"email":176},"Mergan Naidoo, PhD","+27835005334","naidoom@ukzn.ac.za",{"name":174,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":179,"status":57,"city":180,"state":181,"zip":182,"country":149,"countryCode":150,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Tshepong Hospital","Klerksdorp","North West","2574",{"type":63,"coordinates":184},[185,186],26.66672,-26.85213,{"lat":186,"lon":185},[189,192,195,196],{"name":190,"role":47,"phone":24,"phoneExt":24,"email":191},"Alistair Calver, MBChB","acalver@nwpg.gov.za",{"name":193,"role":47,"phone":24,"phoneExt":24,"email":194},"Ebrahim Variava, MBChB","variava@worldonline.co.za",{"name":190,"role":36,"phone":24,"phoneExt":24,"email":24},{"name":193,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":198,"status":57,"city":199,"state":200,"zip":201,"country":149,"countryCode":150,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Mitchell's Plain District Hospital","Cape Town","Western Cape","7785",{"type":63,"coordinates":203},[204,205],18.42322,-33.92584,{"lat":205,"lon":204},[208],{"name":209,"role":47,"phone":24,"phoneExt":24,"email":210},"Katya Evans, MBCHB","k.evans@uct.ac.za",{"facility":212,"status":57,"city":199,"state":200,"zip":213,"country":149,"countryCode":150,"cosmosGeoPoint":214,"geoPoint":216,"contacts":217},"Groote Schuur Hospital","8000",{"type":63,"coordinates":215},[204,205],{"lat":205,"lon":204},[218,219,221,222],{"name":46,"role":47,"phone":48,"phoneExt":24,"email":49},{"name":35,"role":47,"phone":24,"phoneExt":24,"email":220},"mpiko.ntsekhe@uct.ac.za",{"name":46,"role":36,"phone":24,"phoneExt":24,"email":24},{"name":35,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":224,"status":57,"city":199,"state":200,"zip":213,"country":149,"countryCode":150,"cosmosGeoPoint":225,"geoPoint":227,"contacts":228},"Victoria Hospital",{"type":63,"coordinates":226},[204,205],{"lat":205,"lon":204},[229,233],{"name":230,"role":47,"phone":231,"phoneExt":24,"email":232},"Nasief Van Der Schyff, MBChB","+27721910835","nasief@gmail.com",{"name":230,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":235,"status":57,"city":236,"state":200,"zip":237,"country":149,"countryCode":150,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"George Hospital","George","6530",{"type":63,"coordinates":239},[240,241],22.46173,-33.963,{"lat":241,"lon":240},[244,248],{"name":245,"role":47,"phone":246,"phoneExt":24,"email":247},"Trevor Gould, MBChB","+27837741212","trevor.gould@westerncape.gov.za",{"name":245,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":250,"status":57,"city":251,"state":252,"zip":24,"country":253,"countryCode":254,"cosmosGeoPoint":255,"geoPoint":259,"contacts":260},"Al Saha Specialised Hospital","Khartoum","Khartoum State","Sudan","SD",{"type":63,"coordinates":256},[257,258],32.53241,15.55177,{"lat":258,"lon":257},[261,264],{"name":262,"role":47,"phone":24,"phoneExt":24,"email":263},"Mohamed E Elfadl Abdelhameed, MBChB","Alryanalhadi13@gmail.com",{"name":262,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":266,"status":57,"city":251,"state":252,"zip":24,"country":253,"countryCode":254,"cosmosGeoPoint":267,"geoPoint":269,"contacts":270},"Al Shaab Teaching Hospital",{"type":63,"coordinates":268},[257,258],{"lat":258,"lon":257},[271,274,277,278],{"name":272,"role":47,"phone":24,"phoneExt":24,"email":273},"Awad Mohamed, PhD","awad90000@gmail.com",{"name":275,"role":47,"phone":24,"phoneExt":24,"email":276},"Eltayeb Hamid, MBChB","eltayebhamid@yahoo.com",{"name":272,"role":36,"phone":24,"phoneExt":24,"email":24},{"name":275,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":280,"status":57,"city":251,"state":252,"zip":24,"country":253,"countryCode":254,"cosmosGeoPoint":281,"geoPoint":283,"contacts":284},"Sudan Heart Centre",{"type":63,"coordinates":282},[257,258],{"lat":258,"lon":257},[285,288],{"name":286,"role":47,"phone":24,"phoneExt":24,"email":287},"Abdelbagi S Ali, MBChB","abdelbagisd@gmail.com",{"name":286,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":290,"status":57,"city":251,"state":252,"zip":24,"country":253,"countryCode":254,"cosmosGeoPoint":291,"geoPoint":293,"contacts":294},"The Royal Care International Hospital",{"type":63,"coordinates":292},[257,258],{"lat":258,"lon":257},[295,297],{"name":296,"role":47,"phone":24,"phoneExt":24,"email":273},"Awad A Mohamed, PhD",{"name":296,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":299,"status":57,"city":300,"state":300,"zip":24,"country":253,"countryCode":254,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Aliaa Specialist Hospital","Omdurman",{"type":63,"coordinates":302},[303,304],32.47773,15.64453,{"lat":304,"lon":303},[307,310],{"name":308,"role":47,"phone":24,"phoneExt":24,"email":309},"Ehab Ali Elmakki, MBChB","ehabalmakki@gmail.com",{"name":308,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":312,"status":57,"city":313,"state":24,"zip":24,"country":253,"countryCode":254,"cosmosGeoPoint":314,"geoPoint":318,"contacts":319},"Medani Heart Centre","Wad Medani",{"type":63,"coordinates":315},[316,317],33.51989,14.40118,{"lat":317,"lon":316},[320,323],{"name":321,"role":47,"phone":24,"phoneExt":24,"email":322},"Omaima Abozaid, MBChB","Dr.omaima2017@outlook.com",{"name":321,"role":36,"phone":24,"phoneExt":24,"email":24},{"facility":325,"status":57,"city":326,"state":326,"zip":24,"country":327,"countryCode":328,"cosmosGeoPoint":329,"geoPoint":333,"contacts":334},"Uganda Heart Institute","Kampala","Uganda","UG",{"type":63,"coordinates":330},[331,332],32.58219,0.31628,{"lat":332,"lon":331},[335,338,341,342],{"name":336,"role":47,"phone":24,"phoneExt":24,"email":337},"Emmy Okello, MBChB","emmyoks@gmail.com",{"name":339,"role":47,"phone":24,"phoneExt":24,"email":340},"Brian Kiggundu, MBChB","makabrian@gmail.com",{"name":336,"role":36,"phone":24,"phoneExt":24,"email":24},{"name":339,"role":36,"phone":24,"phoneExt":24,"email":24},{"type":36,"investigatorFullName":344,"investigatorTitle":345,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Mpiko Ntsekhe","Professor",[347,350,351,353,355,357,359,361,363,365,367,369,371,373,375,377,379,381,383,385,387],{"name":348,"class":349},"Groote Schuur Hospital, South Africa","UNKNOWN",{"name":325,"class":6},{"name":352,"class":349},"Mombasa Hospital, Kenya",{"name":354,"class":349},"Coast General Teaching Hospital, Kenya",{"name":89,"class":356},"OTHER_GOV",{"name":358,"class":349},"Al Shaab Teaching Hospital, Sudan",{"name":360,"class":349},"Sudan Heart Centre, Sudan",{"name":362,"class":349},"Aliaa Specialist Hospital, Sudan",{"name":364,"class":349},"Medani Heart Centre, Sudan",{"name":366,"class":349},"Al Saha Specialised Hospital, Sudan",{"name":368,"class":349},"Omdurman Hospital, Sudan",{"name":370,"class":349},"Victoria Hospital, South Africa",{"name":372,"class":349},"George Hospital, South Africa",{"name":374,"class":349},"Charlotte Maxeke Hospital, South Africa",{"name":376,"class":349},"Tshepong Hospital, South Africa",{"name":378,"class":349},"Wentworth Hospital, South Africa",{"name":380,"class":6},"Grey's Hospital",{"name":382,"class":349},"Universitas Academic Hospital, South Africa",{"name":384,"class":6},"University College, London",{"name":386,"class":349},"Royal Care international Hospital, Sudan",{"name":388,"class":349},"Nairobi West Hospital, Kenya","100424919","remote-ischaemic-conditioning-in-stemi-patients-in-africa-100424919",false,"NCT04813159","Remote Ischaemic Conditioning in STEMI Patients in AFRICA","Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial","RIC-AFRICA","We will be recruiting 3 different strata of STEMI patients.\n\n1. Adult patients (≥18 years old) presenting with STEMI receiving thrombolytic therapy within guideline-recommended time (i.e., within \\\u003C12 hours of most severe chest pain onset).\n2. Adult patients (≥18 years old) presenting with STEMI who are ineligible for thrombolysis because they present outside of guideline-recommended time (\\\u003C12 hours) but within 24 hours of most severe chest pain onset.\n3. Adult patients (≥18 years old) presenting with evidence of STEMI who do not receive thrombolysis and who present ≥24 hours and within 72 hours of most severe chest pain onset.\n\nInterventional arm of the Study: Randomized Control Trial\n\nPatients who are deemed eligible for randomization into the trial on account of presentation with STEMI within 24 hours, will be eligible for the interventional arm of the study if the following inclusion\u002Fexclusion criteria are met.\n\nInclusion Criteria\n\nI. Adult patients (≥18 years old) presenting with suspected STEMI (ST-elevation at the J-point in two contiguous leads ( ≥ 0.2mV in men or ≥ 0.15mV in women in leads V2-V3 and\u002For ≥ 0.1mV in other lead); and II. Within 24 hours of onset of myocardial infarction as deemed by the attending clinician; and III. Signed informed consent.\n\nExclusion criteria\n\nI. STEMI patients due to undergo primary percutaneous coronary intervention;\n\nII. STEMI patients presenting with cardiogenic shock or haemodynamic instability as defined by: systolic blood pressure (SBP) measurement of \\\u003C90 mm Hg for ≥30 minutes; or use of pharmacological and\u002For mechanical support to maintain SBP ≥ 90 mm Hg; and evidence of end-organ damage defined by: urine output of \\\u003C30 mL\u002Fh; altered mental status; and\u002For serum lactate \\>2.0 mmol\u002FL;\n\nIII. Contraindications for the use of RIC or sham-control on either arm such as:\n\n1. severe active skin disease\u002Fburns on both arms; or\n2. bilateral upper limb amputations; or\n3. evidence of acute limb ischaemia on either arm; or\n4. active upper limb gangrene of any digits;\n5. breast cancer with lymph-node involvement on the ipsilateral side of RIC; or\n6. bilateral arteriovenous fistulae needed for haemodialysis.\n\nIV. Inter-current disease with an expected life expectancy of less than 24 hours;\n\nV. Contra-indication to thrombolytic therapy in patients presenting within guideline-recommended time (\\\u003C12 hours).\n\nObservational arm of the study\n\nPatients who are deemed ineligible for randomization into the trial on account of presentation beyond 24 hours, will be eligible for the observational arm of the study if the following inclusion\u002Fexclusion criteria are met.\n\nInclusion Criteria\n\nI. Signed informed consent; and\n\nII. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:\n\n1. Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and\n2. Compatible biomarkers (elevated cardiac troponin); and\n3. ECG compatible with recent STEMI; and\u002For\n4. Compatible echocardiography.\n\nExclusion criteria\n\nI. Refusal or inability to sign informed consent.","ALL","18 Years",{"count":400,"type":401},1400,"ESTIMATED","INTERVENTIONAL",[404],"NA","The RIC-AFRICA trial is a multi-centre, sham-controlled, randomised controlled trial (RCT) involving 1400 ST-segment elevation myocardial infarction (STEMI) patients presenting within ≤ 24 hours of myocardial infarction (MI) onset, across approximately 25 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients presenting with STEMI and deemed ineligible for the RIC AFRICA RCT because they present \\>24 hours from MI onset but less than 72 hours, will be recruited into the observational arm of the study with the same endpoints as the trial. The purpose of the RCT is to determine whether Remote Ischaemic Conditioning (RIC) can reduce the rates of all-cause death and early post-myocardial heart failure at 30-days in STEMI patients treated predominantly with thrombolytic therapy.",[407,408,409],"STEMI","Remote Ischaemic Conditioning","Myocardial Reperfusion Injury",[411,412,413,414,408,415,407],"Cardioprotection","Ischaemia\u002Freperfusion injury","ST-Elevation myocardial infarction","Hospitalisation for post-myocardial infarction heart failure","Cardiovascular mortality","2025-03-31",{"date":418,"type":419},"2025-04-03","ACTUAL",{"date":421,"type":419},"2022-01-12",{"date":423,"type":401},"2027-12-31",{"name":5,"class":6},20]