Remote Ischaemic Conditioning in STEMI patients in sub-Saharan AFRICA: The RIC-AFRICA trial

niversity of Cape Town0 sites1,200 target enrollmentNovember 29, 2021

Overview

No summary available.

Registry

who.int

Start Date

November 29, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Cape Town

•Eligible 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, i.e., \= 0\.2mV in men \=40 years (\=0\.25 mV in men \<40 years); 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.

•Interventional arm of the study: Randomized Control Trial
•Exclusion criteria
•I. STEMI patients undergoing primary percutaneous coronary intervention;
•II. STEMI patients presenting with cardiogenic shock or haemodynamic instability (systolic blood pressure (SBP) \<90 mmHg for \=30 minutes; or use of pharmacological and/or mechanical support to maintain SBP \= 90 mmHg; and evidence of end\-organ damage such as urine output of \<30 mL/h; altered mental status; and/or serum lactate \>2\.0 mmol/L);
•III. Contra\-indication to thrombolytic therapy in patients presenting within guideline\-recommended time (\<12 hours);
•IV. Conditions that preclude the use of RIC or sham\-control on either arm such as:
•a. severe active skin disease/burns on both arms; or
•b. bilateral upper limb amputations; or
•c. evidence of acute limb ischaemia on either arm; or
•d. active upper limb gangrene of any digits; or