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Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA (RIC-AFRICA)

Primary Purpose

STEMI, Remote Ischaemic Conditioning, Myocardial Reperfusion Injury

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Remote Ischaemic Conditioning (RIC)
Sham-control
Sponsored by
University of Cape Town
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI focused on measuring Cardioprotection, Ischaemia/reperfusion injury, ST-Elevation myocardial infarction, Hospitalisation for post-myocardial infarction heart failure, Remote Ischaemic Conditioning, Cardiovascular mortality, STEMI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

We will be recruiting 3 different strata of STEMI patients.

  1. 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).
  2. 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.
  3. 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.

Interventional arm of the Study: Randomized Control Trial

Patients 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.

Inclusion Criteria

I. 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.

Exclusion criteria

I. STEMI patients due to undergo primary percutaneous coronary intervention;

II. 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;

III. Contraindications for the use of RIC or sham-control on either arm such as:

  1. severe active skin disease/burns on both arms; or
  2. bilateral upper limb amputations; or
  3. evidence of acute limb ischaemia on either arm; or
  4. active upper limb gangrene of any digits;
  5. breast cancer with lymph-node involvement on the ipsilateral side of RIC; or
  6. bilateral arteriovenous fistulae needed for haemodialysis.

IV. Inter-current disease with an expected life expectancy of less than 24 hours;

V. Contra-indication to thrombolytic therapy in patients presenting within guideline-recommended time (<12 hours).

Observational arm of the study

Patients 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.

Inclusion Criteria

I. Signed informed consent; and

II. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:

  1. Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and
  2. Compatible biomarkers (elevated cardiac troponin); and
  3. ECG compatible with recent STEMI; and/or
  4. Compatible echocardiography.

Exclusion criteria

I. Refusal or inability to sign informed consent.

Sites / Locations

  • Coast General Teaching HospitalRecruiting
  • Mombasa HospitalRecruiting
  • Kenyatta National HospitalRecruiting
  • Nairobi West hospitalRecruiting
  • Charlotte Maxeke Hospital
  • Wentworth HospitalRecruiting
  • Tshepong HospitalRecruiting
  • Mitchell's Plain District Hospital
  • Groote Schuur HospitalRecruiting
  • Victoria HospitalRecruiting
  • George HospitalRecruiting
  • Al Saha Specialised HospitalRecruiting
  • Al Shaab Teaching HospitalRecruiting
  • Sudan Heart CentreRecruiting
  • The Royal Care International HospitalRecruiting
  • Aliaa Specialist HospitalRecruiting
  • Medani Heart CentreRecruiting
  • Uganda Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

No Intervention

Arm Label

Remote Ischaemic Conditioning (RIC)

Sham-control

Observational

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

All-cause death and early post-MI heart failure
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.

Secondary Outcome Measures

Composite clinical endpoint for MACCE
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.

Full Information

First Posted
March 20, 2021
Last Updated
June 23, 2023
Sponsor
University of Cape Town
Collaborators
Groote Schuur Hospital, South Africa, Uganda Heart Institute, Mombasa Hospital, Kenya, Coast General Teaching Hospital, Kenya, Kenyatta National Hospital, Al Shaab Teaching Hospital, Sudan, Sudan Heart Centre, Sudan, Aliaa Specialist Hospital, Sudan, Medani Heart Centre, Sudan, Al Saha Specialised Hospital, Sudan, Omdurman Hospital, Sudan, Victoria Hospital, South Africa, George Hospital, South Africa, Charlotte Maxeke Hospital, South Africa, Tshepong Hospital, South Africa, Wentworth Hospital, South Africa, Grey's Hospital, Universitas Academic Hospital, South Africa, University College, London, Royal Care international Hospital, Sudan, Nairobi West Hospital, Kenya
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1. Study Identification

Unique Protocol Identification Number
NCT04813159
Brief Title
Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA
Acronym
RIC-AFRICA
Official Title
Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA: The RIC-AFRICA Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cape Town
Collaborators
Groote Schuur Hospital, South Africa, Uganda Heart Institute, Mombasa Hospital, Kenya, Coast General Teaching Hospital, Kenya, Kenyatta National Hospital, Al Shaab Teaching Hospital, Sudan, Sudan Heart Centre, Sudan, Aliaa Specialist Hospital, Sudan, Medani Heart Centre, Sudan, Al Saha Specialised Hospital, Sudan, Omdurman Hospital, Sudan, Victoria Hospital, South Africa, George Hospital, South Africa, Charlotte Maxeke Hospital, South Africa, Tshepong Hospital, South Africa, Wentworth Hospital, South Africa, Grey's Hospital, Universitas Academic Hospital, South Africa, University College, London, Royal Care international Hospital, Sudan, Nairobi West Hospital, Kenya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The RIC-AFRICA trial is a multi-centre, sham-controlled, double-blinded, randomised controlled trial (RCT) involving 1200 ST-segment elevation myocardial infarction (STEMI) patients presenting within ≤ 24 hours of myocardial infarction (MI) onset, across approximately 20 sites in four sub-Saharan African countries (South Africa, Kenya, Sudan and Uganda). 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.
Detailed Description
Background: Remote 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 sub-Saharan Africa. Study design: The RIC-AFRICA trial is a multi-centre, sham-controlled, double-blinded, randomised controlled trial (RCT) involving 1200 ST-segment elevation myocardial infarction (STEMI) patients presenting within ≤ 24 hours of myocardial infarction (MI) onset, across approximately 20 sites in four sub-Saharan African countries (South Africa, Kenya, Sudan and Uganda). 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. Implications: The 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 sub-Saharan Africa, thereby potentially providing a low-cost, non-invasive therapy for improving health outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI, Remote Ischaemic Conditioning, Myocardial Reperfusion Injury
Keywords
Cardioprotection, Ischaemia/reperfusion injury, ST-Elevation myocardial infarction, Hospitalisation for post-myocardial infarction heart failure, Remote Ischaemic Conditioning, Cardiovascular mortality, STEMI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Ischaemic Conditioning (RIC)
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham-control
Arm Type
Sham Comparator
Arm 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.
Arm Title
Observational
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Remote Ischaemic Conditioning (RIC)
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Sham-control
Intervention 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.
Primary Outcome Measure Information:
Title
All-cause death and early post-MI heart failure
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Composite clinical endpoint for MACCE
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
We will be recruiting 3 different strata of STEMI patients. 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). 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. 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. Interventional arm of the Study: Randomized Control Trial Patients 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. Inclusion Criteria I. 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. Exclusion criteria I. STEMI patients due to undergo primary percutaneous coronary intervention; II. 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; III. Contraindications for the use of RIC or sham-control on either arm such as: severe active skin disease/burns on both arms; or bilateral upper limb amputations; or evidence of acute limb ischaemia on either arm; or active upper limb gangrene of any digits; breast cancer with lymph-node involvement on the ipsilateral side of RIC; or bilateral arteriovenous fistulae needed for haemodialysis. IV. Inter-current disease with an expected life expectancy of less than 24 hours; V. Contra-indication to thrombolytic therapy in patients presenting within guideline-recommended time (<12 hours). Observational arm of the study Patients 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. Inclusion Criteria I. Signed informed consent; and II. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by: Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and Compatible biomarkers (elevated cardiac troponin); and ECG compatible with recent STEMI; and/or Compatible echocardiography. Exclusion criteria I. Refusal or inability to sign informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kishal Lukhna, MBChB
Phone
+27732515380
Email
kishallukhna@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Giesz
Phone
+44(0)20 3447 9888
Email
s.giesz@ucl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mpiko Ntsekhe, PhD
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derek Hausenloy, PhD
Organizational Affiliation
Hatter Cardiovascular Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Derek Yellon, PhD
Organizational Affiliation
Hatter Cardiovascular Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Malcolm Walker, PhD
Organizational Affiliation
Hatter Cardiovascular Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coast General Teaching Hospital
City
Mombasa
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keiran Mwazo, MBChB
Email
kmwasha@yahoo.com
First Name & Middle Initial & Last Name & Degree
Vickie Mumbo, MBChB
Email
mumbovickie@gmail.com
First Name & Middle Initial & Last Name & Degree
Keiran Mwazo, MBChB
First Name & Middle Initial & Last Name & Degree
Vickie Mumbo, MBChB
Facility Name
Mombasa Hospital
City
Mombasa
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah A Bajaber, MBChB
Email
baja1930@gmail.com
First Name & Middle Initial & Last Name & Degree
Abdullah A Bajaber, MBChB
Facility Name
Kenyatta National Hospital
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elijah Ogola, PhD
Email
Elijah.ogola@uonbi.ac.ke
First Name & Middle Initial & Last Name & Degree
Elijah Ogola, PhD
Facility Name
Nairobi West hospital
City
Nairobi
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elijah Elijah, PhD
Email
elijah.ogola@uonbi.ac.ke
First Name & Middle Initial & Last Name & Degree
Elijah Elijah, PhD
Facility Name
Charlotte Maxeke Hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur Mutyab, MBChB
Phone
+27724267928
Email
akaggwe@yahoo.com
First Name & Middle Initial & Last Name & Degree
Arthur Mutyab, MBChB
Facility Name
Wentworth Hospital
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4026
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mergan Naidoo, PhD
Phone
+27835005334
Email
naidoom@ukzn.ac.za
First Name & Middle Initial & Last Name & Degree
Mergan Naidoo, PhD
Facility Name
Tshepong Hospital
City
Klerksdorp
State/Province
North West
ZIP/Postal Code
2574
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alistair Calver, MBChB
Email
acalver@nwpg.gov.za
First Name & Middle Initial & Last Name & Degree
Ebrahim Variava, MBChB
Email
variava@worldonline.co.za
First Name & Middle Initial & Last Name & Degree
Alistair Calver, MBChB
First Name & Middle Initial & Last Name & Degree
Ebrahim Variava, MBChB
Facility Name
Mitchell's Plain District Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7785
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katya Evans, MBCHB
Email
k.evans@uct.ac.za
Facility Name
Groote Schuur Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
8000
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kishal Lukhna, MBChB
Phone
+27732515380
Email
kishallukhna@gmail.com
First Name & Middle Initial & Last Name & Degree
Mpiko Ntsekhe, PhD
Email
mpiko.ntsekhe@uct.ac.za
First Name & Middle Initial & Last Name & Degree
Kishal Lukhna, MBChB
First Name & Middle Initial & Last Name & Degree
Mpiko Ntsekhe, PhD
Facility Name
Victoria Hospital
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
8000
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasief Van Der Schyff, MBChB
Phone
+27721910835
Email
nasief@gmail.com
First Name & Middle Initial & Last Name & Degree
Nasief Van Der Schyff, MBChB
Facility Name
George Hospital
City
George
State/Province
Western Cape
ZIP/Postal Code
6530
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trevor Gould, MBChB
Phone
+27837741212
Email
trevor.gould@westerncape.gov.za
First Name & Middle Initial & Last Name & Degree
Trevor Gould, MBChB
Facility Name
Al Saha Specialised Hospital
City
Khartoum
State/Province
Khartoum State
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed E Elfadl Abdelhameed, MBChB
Email
Alryanalhadi13@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed E Elfadl Abdelhameed, MBChB
Facility Name
Al Shaab Teaching Hospital
City
Khartoum
State/Province
Khartoum State
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Awad Mohamed, PhD
Email
awad90000@gmail.com
First Name & Middle Initial & Last Name & Degree
Eltayeb Hamid, MBChB
Email
eltayebhamid@yahoo.com
First Name & Middle Initial & Last Name & Degree
Awad Mohamed, PhD
First Name & Middle Initial & Last Name & Degree
Eltayeb Hamid, MBChB
Facility Name
Sudan Heart Centre
City
Khartoum
State/Province
Khartoum State
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelbagi S Ali, MBChB
Email
abdelbagisd@gmail.com
First Name & Middle Initial & Last Name & Degree
Abdelbagi S Ali, MBChB
Facility Name
The Royal Care International Hospital
City
Khartoum
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Awad A Mohamed, PhD
Email
awad90000@gmail.com
First Name & Middle Initial & Last Name & Degree
Awad A Mohamed, PhD
Facility Name
Aliaa Specialist Hospital
City
Omdurman
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehab Ali Elmakki, MBChB
Email
ehabalmakki@gmail.com
First Name & Middle Initial & Last Name & Degree
Ehab Ali Elmakki, MBChB
Facility Name
Medani Heart Centre
City
Wad Medani
Country
Sudan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omaima Abozaid, MBChB
Email
Dr.omaima2017@outlook.com
First Name & Middle Initial & Last Name & Degree
Omaima Abozaid, MBChB
Facility Name
Uganda Heart Institute
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmy Okello, MBChB
Email
emmyoks@gmail.com
First Name & Middle Initial & Last Name & Degree
Brian Kiggundu, MBChB
Email
makabrian@gmail.com
First Name & Middle Initial & Last Name & Degree
Emmy Okello, MBChB
First Name & Middle Initial & Last Name & Degree
Brian Kiggundu, MBChB

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34739648
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.
Results Reference
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Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA

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