Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-27 @ 12:54 PM
Study NCT ID:
NCT04813159
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2021-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Ischaemic Conditioning in STEMI Patients in AFRICA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}, {'id': 'D015428', 'term': 'Myocardial Reperfusion Injury'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient, treating clinician, study investigator and research team analysing the data will be blinded to the treatment allocation. Study intervention will be applied by the research nurse who will not have any further contact with the participant or trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Consented participants presenting with STEMI within 24 hours and who fulfil the study's eligibility criteria will be assigned a participant identification number and randomised to receive either RIC or sham control in a 1:1 ratio to ensure equal distribution amongst experimental arm. Randomisation will be conducted via a secure website and will be stratified by recruiting centre and patient stratum to ensure that a minimum of 2 participants in stratum 1 (eligible for thrombolysis and within \\<12 hours of MI onset) are recruited for every participant in stratum 2 (ineligible for thrombolysis because they present outside of guideline-recommended time (\\<12 hours) but presenting within 24 hours of most severe chest pain onset). The patient, treating clinician, study investigator and research team analysing the data will be blinded to the treatment allocation. Study intervention will be applied by the research nurse who will not have any further contact with the participant or trial."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2021-03-20', 'studyFirstSubmitQcDate': '2021-03-20', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause death and early post-MI heart failure', 'timeFrame': '30 days', 'description': 'The primary endpoint of the study will be a composite of all-cause death and early post-MI heart failure. The latter describes both a\\] pre-discharge (in-hospital) heart failure; or b\\] post discharge heart failure hospitalisation within 30 days for patients discharged free of heart failure after the index MI admission.'}], 'secondaryOutcomes': [{'measure': 'Composite clinical endpoint for MACCE', 'timeFrame': '30 days', 'description': 'Secondary outcome measures will include a composite clinical endpoint of MACCE at 30 days follow-up, defined as rates of (i) all-cause mortality; (ii) non-fatal myocardial infarction; (iii) transient ischaemic attack or stroke; and (iv) heart failure with or without hospitalisation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardioprotection', 'Ischaemia/reperfusion injury', 'ST-Elevation myocardial infarction', 'Hospitalisation for post-myocardial infarction heart failure', 'Remote Ischaemic Conditioning', 'Cardiovascular mortality', 'STEMI'], 'conditions': ['STEMI', 'Remote Ischaemic Conditioning', 'Myocardial Reperfusion Injury']}, 'referencesModule': {'references': [{'pmid': '34739648', 'type': 'BACKGROUND', 'citation': 'Lukhna K, Hausenloy DJ, Ali AS, Bajaber A, Calver A, Mutyaba A, Mohamed AA, Kiggundu B, Chishala C, Variava E, Elmakki EA, Ogola E, Hamid E, Okello E, Gaafar I, Mwazo K, Makotoko M, Naidoo M, Abdelhameed ME, Badri M, van der Schyff N, Abozaid O, Xafis P, Giesz S, Gould T, Welgemoed W, Walker M, Ntsekhe M, Yellon DM. Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: Rationale and Study Design for the RIC-AFRICA Trial. Cardiovasc Drugs Ther. 2023 Apr;37(2):299-305. doi: 10.1007/s10557-021-07283-y. Epub 2021 Nov 5.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background:\n\nRemote ischaemic conditioning (RIC) using transient limb ischaemia and reperfusion has been shown to reduce myocardial infarct size in animal studies and small proof-of-concept clinical studies in ST-segment elevation myocardial infarction (STEMI) patients. However, RIC failed to improve clinical outcomes in the large European CONDI-2/ERIC-PPCI multi-centre randomised clinical trial. Potential reasons for this failure include the low-risk patients recruited into the study and the fact that patients received timely and optimal reperfusion therapy by primary percutaneous coronary intervention. The RIC-AFRICA trial will investigate whether RIC can improve clinical outcomes in higher-risk STEMI patients treated by thrombolysis in Africa.\n\nStudy design:\n\nThe 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 20 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients will be randomised to receive either RIC or sham control initiated prior to thrombolysis and applied daily for the next 2 days. The RIC protocol will comprise four 5-minute cycles of inflation (to 20mmHg above systolic blood pressure) and deflation of an automated pneumatic cuff placed on the upper arm. The sham control protocol will comprise four 5-minute cycles of low-pressure inflation (to 20mmHg) and deflation by a visually identical pneumatic cuff. The primary composite endpoint will be all-cause death and new-onset heart failure at 30-days post STEMI. 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.\n\nImplications:\n\nThe RIC-AFRICA trial will determine whether RIC can reduce rates of death and prevent heart failure in higher-risk STEMI patients treated by thrombolytic therapy in Africa, thereby potentially providing a low-cost, non-invasive therapy for improving health outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\<12 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 (\\<12 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/exclusion 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/or ≥ 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 \\<90 mm Hg for ≥30 minutes; or use of pharmacological and/or mechanical support to maintain SBP ≥ 90 mm Hg; and evidence of end-organ damage defined by: urine output of \\<30 mL/h; altered mental status; and/or serum lactate \\>2.0 mmol/L;\n\nIII. Contraindications for the use of RIC or sham-control on either arm such as:\n\n1. severe active skin disease/burns 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 (\\<12 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/exclusion 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/or\n4. Compatible echocardiography.\n\nExclusion criteria\n\nI. Refusal or inability to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT04813159', 'acronym': 'RIC-AFRICA', 'briefTitle': 'Remote Ischaemic Conditioning in STEMI Patients in AFRICA', 'organization': {'class': 'OTHER', 'fullName': 'University of Cape Town'}, 'officialTitle': 'Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial', 'orgStudyIdInfo': {'id': 'RIC AFRICA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Remote Ischaemic Conditioning (RIC)', 'description': 'Consented STEMI participants presenting \\< 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.', 'interventionNames': ['Device: Remote Ischaemic Conditioning (RIC)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham-control', 'description': 'Consented STEMI participants presenting \\< 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.', 'interventionNames': ['Device: Sham-control']}, {'type': 'NO_INTERVENTION', 'label': 'Observational', 'description': '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.'}], 'interventions': [{'name': 'Remote Ischaemic Conditioning (RIC)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Remote Ischaemic Conditioning (RIC)']}, {'name': 'Sham-control', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Sham-control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mombasa', 'state': 'Mombasa County', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Keiran Mwazo, MBChB', 'role': 'CONTACT', 'email': 'kmwasha@yahoo.com'}, {'name': 'Vickie Mumbo, MBChB', 'role': 'CONTACT', 'email': 'mumbovickie@gmail.com'}, {'name': 'Keiran Mwazo, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Vickie Mumbo, MBChB', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Coast General Teaching Hospital', 'geoPoint': {'lat': -4.05466, 'lon': 39.66359}}, {'city': 'Mombasa', 'state': 'Mombasa County', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Abdullah A Bajaber, MBChB', 'role': 'CONTACT', 'email': 'baja1930@gmail.com'}, {'name': 'Abdullah A Bajaber, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mombasa Hospital', 'geoPoint': {'lat': -4.05466, 'lon': 39.66359}}, {'city': 'Nairobi', 'state': 'Nairobi County', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Elijah Ogola, PhD', 'role': 'CONTACT', 'email': 'Elijah.ogola@uonbi.ac.ke'}, {'name': 'Elijah Ogola, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kenyatta National Hospital', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}, {'city': 'Nairobi', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Elijah Elijah, PhD', 'role': 'CONTACT', 'email': 'elijah.ogola@uonbi.ac.ke'}, {'name': 'Elijah Elijah, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nairobi West hospital', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}, {'city': 'Maputo', 'status': 'RECRUITING', 'country': 'Mozambique', 'contacts': [{'name': 'Neusa Jensen, MBCHB, PhD', 'role': 'CONTACT', 'email': 'neusa.jessen@gmail.com'}, {'name': 'Neusa Jensen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Central de Mpauto', 'geoPoint': {'lat': -25.96553, 'lon': 32.58322}}, {'city': 'Dakar', 'status': 'RECRUITING', 'country': 'Senegal', 'contacts': [{'name': 'Cherif Mboup, MBCHB, PHD', 'role': 'CONTACT', 'email': 'mcmboup@yahoo.fr'}, {'name': 'Cherif Mboup', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Principal de Dakar', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}, {'zip': '2193', 'city': 'Johannesburg', 'state': 'Gauteng', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Arthur Mutyab, MBChB', 'role': 'CONTACT', 'email': 'akaggwe@yahoo.com', 'phone': '+27724267928'}, {'name': 'Arthur Mutyab, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charlotte Maxeke Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '4026', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Mergan Naidoo, PhD', 'role': 'CONTACT', 'email': 'naidoom@ukzn.ac.za', 'phone': '+27835005334'}, {'name': 'Mergan Naidoo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wentworth Hospital', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '2574', 'city': 'Klerksdorp', 'state': 'North West', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Alistair Calver, MBChB', 'role': 'CONTACT', 'email': 'acalver@nwpg.gov.za'}, {'name': 'Ebrahim Variava, MBChB', 'role': 'CONTACT', 'email': 'variava@worldonline.co.za'}, {'name': 'Alistair Calver, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ebrahim Variava, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tshepong Hospital', 'geoPoint': {'lat': -26.85213, 'lon': 26.66672}}, {'zip': '7785', 'city': 'Cape Town', 'state': 'Western Cape', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Katya Evans, MBCHB', 'role': 'CONTACT', 'email': 'k.evans@uct.ac.za'}], 'facility': "Mitchell's Plain District Hospital", 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '8000', 'city': 'Cape Town', 'state': 'Western Cape', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Kishal Lukhna, MBChB', 'role': 'CONTACT', 'email': 'kishallukhna@gmail.com', 'phone': '+27732515380'}, {'name': 'Mpiko Ntsekhe, PhD', 'role': 'CONTACT', 'email': 'mpiko.ntsekhe@uct.ac.za'}, {'name': 'Kishal Lukhna, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mpiko Ntsekhe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '8000', 'city': 'Cape Town', 'state': 'Western Cape', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Nasief Van Der Schyff, MBChB', 'role': 'CONTACT', 'email': 'nasief@gmail.com', 'phone': '+27721910835'}, {'name': 'Nasief Van Der Schyff, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Victoria Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '6530', 'city': 'George', 'state': 'Western Cape', 'status': 'RECRUITING', 'country': 'South Africa', 'contacts': [{'name': 'Trevor Gould, MBChB', 'role': 'CONTACT', 'email': 'trevor.gould@westerncape.gov.za', 'phone': '+27837741212'}, {'name': 'Trevor Gould, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'George Hospital', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'city': 'Khartoum', 'state': 'Khartoum State', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Mohamed E Elfadl Abdelhameed, MBChB', 'role': 'CONTACT', 'email': 'Alryanalhadi13@gmail.com'}, {'name': 'Mohamed E Elfadl Abdelhameed, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Al Saha Specialised Hospital', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}, {'city': 'Khartoum', 'state': 'Khartoum State', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Awad Mohamed, PhD', 'role': 'CONTACT', 'email': 'awad90000@gmail.com'}, {'name': 'Eltayeb Hamid, MBChB', 'role': 'CONTACT', 'email': 'eltayebhamid@yahoo.com'}, {'name': 'Awad Mohamed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eltayeb Hamid, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Al Shaab Teaching Hospital', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}, {'city': 'Khartoum', 'state': 'Khartoum State', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Abdelbagi S Ali, MBChB', 'role': 'CONTACT', 'email': 'abdelbagisd@gmail.com'}, {'name': 'Abdelbagi S Ali, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sudan Heart Centre', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}, {'city': 'Khartoum', 'state': 'Khartoum State', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Awad A Mohamed, PhD', 'role': 'CONTACT', 'email': 'awad90000@gmail.com'}, {'name': 'Awad A Mohamed, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Royal Care International Hospital', 'geoPoint': {'lat': 15.55177, 'lon': 32.53241}}, {'city': 'Omdurman', 'state': 'Omdurman', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Ehab Ali Elmakki, MBChB', 'role': 'CONTACT', 'email': 'ehabalmakki@gmail.com'}, {'name': 'Ehab Ali Elmakki, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aliaa Specialist Hospital', 'geoPoint': {'lat': 15.64453, 'lon': 32.47773}}, {'city': 'Wad Medani', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Omaima Abozaid, MBChB', 'role': 'CONTACT', 'email': 'Dr.omaima2017@outlook.com'}, {'name': 'Omaima Abozaid, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medani Heart Centre', 'geoPoint': {'lat': 14.40118, 'lon': 33.51989}}, {'city': 'Kampala', 'state': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Emmy Okello, MBChB', 'role': 'CONTACT', 'email': 'emmyoks@gmail.com'}, {'name': 'Brian Kiggundu, MBChB', 'role': 'CONTACT', 'email': 'makabrian@gmail.com'}, {'name': 'Emmy Okello, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Brian Kiggundu, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uganda Heart Institute', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'centralContacts': [{'name': 'Kishal Lukhna, MBChB', 'role': 'CONTACT', 'email': 'kishallukhna@gmail.com', 'phone': '+27732515380'}, {'name': 'Sara Giesz', 'role': 'CONTACT', 'email': 's.giesz@ucl.ac.uk', 'phone': '+44(0)20 3447 9888'}], 'overallOfficials': [{'name': 'Mpiko Ntsekhe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cape Town'}, {'name': 'Derek Hausenloy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hatter Cardiovascular Institute'}, {'name': 'Derek Yellon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hatter Cardiovascular Institute'}, {'name': 'Malcolm Walker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hatter Cardiovascular Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cape Town', 'class': 'OTHER'}, 'collaborators': [{'name': 'Groote Schuur Hospital, South Africa', 'class': 'UNKNOWN'}, {'name': 'Uganda Heart Institute', 'class': 'OTHER'}, {'name': 'Mombasa Hospital, Kenya', 'class': 'UNKNOWN'}, {'name': 'Coast General Teaching Hospital, Kenya', 'class': 'UNKNOWN'}, {'name': 'Kenyatta National Hospital', 'class': 'OTHER_GOV'}, {'name': 'Al Shaab Teaching Hospital, Sudan', 'class': 'UNKNOWN'}, {'name': 'Sudan Heart Centre, Sudan', 'class': 'UNKNOWN'}, {'name': 'Aliaa Specialist Hospital, Sudan', 'class': 'UNKNOWN'}, {'name': 'Medani Heart Centre, Sudan', 'class': 'UNKNOWN'}, {'name': 'Al Saha Specialised Hospital, Sudan', 'class': 'UNKNOWN'}, {'name': 'Omdurman Hospital, Sudan', 'class': 'UNKNOWN'}, {'name': 'Victoria Hospital, South Africa', 'class': 'UNKNOWN'}, {'name': 'George Hospital, South Africa', 'class': 'UNKNOWN'}, {'name': 'Charlotte Maxeke Hospital, South Africa', 'class': 'UNKNOWN'}, {'name': 'Tshepong Hospital, South Africa', 'class': 'UNKNOWN'}, {'name': 'Wentworth Hospital, South Africa', 'class': 'UNKNOWN'}, {'name': "Grey's Hospital", 'class': 'OTHER'}, {'name': 'Universitas Academic Hospital, South Africa', 'class': 'UNKNOWN'}, {'name': 'University College, London', 'class': 'OTHER'}, {'name': 'Royal Care international Hospital, Sudan', 'class': 'UNKNOWN'}, {'name': 'Nairobi West Hospital, Kenya', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mpiko Ntsekhe', 'investigatorAffiliation': 'University of Cape Town'}}}}