Status:
RECRUITING
Remote Ischaemic Conditioning in STEMI Patients in AFRICA
Lead Sponsor:
University of Cape Town
Collaborating Sponsors:
Groote Schuur Hospital, South Africa
Uganda Heart Institute
Conditions:
STEMI
Remote Ischaemic Conditioning
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 my...
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT04813159
Start Date
January 12 2022
End Date
December 31 2027
Last Update
April 3 2025
Active Locations (20)
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1
Coast General Teaching Hospital
Mombasa, Mombasa County, Kenya
2
Mombasa Hospital
Mombasa, Mombasa County, Kenya
3
Kenyatta National Hospital
Nairobi, Nairobi County, Kenya
4
Nairobi West hospital
Nairobi, Kenya