Remote Ischaemic Conditioning in STEMI Patients in AFRICA

Launched by UNIVERSITY OF CAPE TOWN · Mar 20, 2021

Keywords

ClinConnect Summary

The RIC-AFRICA trial is studying a treatment called Remote Ischaemic Conditioning (RIC) to see if it can help reduce heart-related problems in patients who have had a heart attack known as STEMI. This trial involves 1,200 patients from South Africa, Kenya, Sudan, and Uganda, who come to the hospital within 24 hours of experiencing severe chest pain. The goal is to find out if RIC can lower the chances of death or heart failure within 30 days after treatment, especially for those receiving a specific type of medication called thrombolytics.

To be eligible for this trial, participants must be at least 18 years old and have signs of a heart attack. They should present to the hospital within 12 hours of their worst chest pain to receive the RIC treatment, or within 24 to 72 hours if they cannot receive thrombolytics. For those who don’t qualify for the main study, there is an observational part where they can still contribute to understanding heart attacks. Participants will receive care and monitoring from medical professionals, and everyone involved will be informed about the study and give their consent before participating.

Gender

ALL

Eligibility criteria

• • 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.