Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04813159

Remote Ischaemic Conditioning in STEMI Patients in AFRICA

Led by University of Cape Town · Updated on 2025-04-03

1400

Participants Needed

20

Research Sites

311 weeks

Total Duration

On this page

Sponsors

U

University of Cape Town

Lead Sponsor

G

Groote Schuur Hospital, South Africa

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Remote Ischaemic Conditioning in STEMI Patients in AFRICA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (18 years or older) with suspected STEMI showing specific ECG changes
  • Presentation within 24 hours of myocardial infarction onset as judged by the clinician
  • Signed informed consent
  • For observational arm: patients with STEMI presenting between 24 and 72 hours after chest pain onset with compatible clinical, biomarker, ECG, or echocardiographic evidence
Not Eligible

You will not qualify if you...

  • Patients planned for primary percutaneous coronary intervention
  • Patients with cardiogenic shock or haemodynamic instability defined by low blood pressure, need for support, and signs of organ damage
  • Patients with severe active skin disease, burns, bilateral arm amputations, acute limb ischaemia, upper limb gangrene, breast cancer with lymph-node involvement on the side of RIC, or bilateral arteriovenous fistulae
  • Patients with other diseases limiting life expectancy to less than 24 hours
  • Patients with contraindications to thrombolytic therapy if presenting within 12 hours
  • Patients refusing or unable to provide informed consent

AI-Screening

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Trial Site Locations

Total: 20 locations

1

Coast General Teaching Hospital

Mombasa, Mombasa County, Kenya

Actively Recruiting

2

Mombasa Hospital

Mombasa, Mombasa County, Kenya

Actively Recruiting

3

Kenyatta National Hospital

Nairobi, Nairobi County, Kenya

Actively Recruiting

4

Nairobi West hospital

Nairobi, Kenya

Actively Recruiting

5

Hospital Central de Mpauto

Maputo, Mozambique

Actively Recruiting

6

Hopital Principal de Dakar

Dakar, Senegal

Actively Recruiting

7

Charlotte Maxeke Hospital

Johannesburg, Gauteng, South Africa, 2193

Actively Recruiting

8

Wentworth Hospital

Durban, KwaZulu-Natal, South Africa, 4026

Actively Recruiting

9

Tshepong Hospital

Klerksdorp, North West, South Africa, 2574

Actively Recruiting

10

Mitchell's Plain District Hospital

Cape Town, Western Cape, South Africa, 7785

Actively Recruiting

11

Groote Schuur Hospital

Cape Town, Western Cape, South Africa, 8000

Actively Recruiting

12

Victoria Hospital

Cape Town, Western Cape, South Africa, 8000

Actively Recruiting

13

George Hospital

George, Western Cape, South Africa, 6530

Actively Recruiting

14

Al Saha Specialised Hospital

Khartoum, Khartoum State, Sudan

Actively Recruiting

15

Al Shaab Teaching Hospital

Khartoum, Khartoum State, Sudan

Actively Recruiting

16

Sudan Heart Centre

Khartoum, Khartoum State, Sudan

Actively Recruiting

17

The Royal Care International Hospital

Khartoum, Khartoum State, Sudan

Actively Recruiting

18

Aliaa Specialist Hospital

Omdurman, Omdurman, Sudan

Actively Recruiting

19

Medani Heart Centre

Wad Medani, Sudan

Actively Recruiting

20

Uganda Heart Institute

Kampala, Kampala, Uganda

Actively Recruiting

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Research Team

K

Kishal Lukhna, MBChB

CONTACT

S

Sara Giesz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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