Remote Ischaemic Conditioning in STEMI Patients in Sub-Saharan AFRICA (RIC-AFRICA)
STEMI, Remote Ischaemic Conditioning, Myocardial Reperfusion Injury
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
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.
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
Active Comparator
Sham Comparator
No Intervention
Remote Ischaemic Conditioning (RIC)
Sham-control
Observational
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.