BridgeMD
New treatment option for STEMI
Official title Remote Ischaemic Conditioning in STEMI Patients in AFRICA
ClinicalTrials.gov ID: NCT04813159
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Adult patients (≥18 years old) presenting with STEMI who are ineligible for thrombolysis because they present outside of guideline-recommended time...
- 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...
You likely can't join if
- are met. Inclusion Criteria I. Adult patients (≥18 years old) presenting with suspected STEMI (ST-elevation at the J-point in two contiguous leads (...
- 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
See the full 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. treatment arm of the Study: assigned by...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mombasa, Mombasa County, Kenya
- Nairobi, Nairobi County, Kenya
- Nairobi, Kenya
- Maputo, Mozambique
- Dakar, Senegal
- Johannesburg, Gauteng, South Africa
- Durban, KwaZulu-Natal, South Africa
- Klerksdorp, North West, South Africa
- Cape Town, Western Cape, South Africa
- George, Western Cape, South Africa
- Khartoum, Khartoum State, Sudan
- Omdurman, Omdurman, Sudan
- Wad Medani, Sudan
- Kampala, Kampala, Uganda
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mombasa, Mombasa County, Kenya; Nairobi, Nairobi County, Kenya; Nairobi, Kenya; Maputo, Mozambique; Dakar, Senegal; Johannesburg, Gauteng, South Africa and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.