Ciclosporin to reduce reperfusion injury in primary percutaneous coronary interventio
- Conditions
- Myocardial reperfusion injuryCirculatory System
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 52
1. Patients presenting with acute myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (primary PCI)
2. Age above 18 years
3. Presenting within 6 hours of the onset chest pain and ST segment elevation. The culprit coronary artery has to be a major coronary artery with a diameter of at least 3 mm and has to be proximally occluded (TIMI flow grade 0-1) at the time of admission coronary angiography
1. Patients with any disorder associated with immunological dysfunction (acute or chronic inflammatory or neoplastic co-existing disease, known positive serology for HIV, or hepatitis)
2. Clinically unstable patients (haemodynamically unstable, cardiogenic shock, unconscious patients)
3. Patients with evidence of coronary collaterals to the infarct area
4. Patients with an open (TIMI > 1) culprit coronary artery at the time of angiography
5. Previous myocardial infarction
6. Previous thrombolytic therapy
7. Patients with known hypersensitivity to ciclosporin or to egg, peanut or soya-bean proteins
8. Patients with known renal insufficiency (either known GFR <30 ml/min/1.73m2) or current medical care for severe renal insufficiency
9. Known liver insufficiency
10. Uncontrolled hypertension (>180/110 mmHg)
11. Patients treated with any compound containing hypericum perforatum, stiripentol, Aliskiren, Bosentan or Rosuvastatin or with an active treatment that might modify blood concentration of ciclosporin
12. Female patients currently pregnant or women of childbearing age who are not using contraception (verbal diagnosis). Female patients of childbearing potential who are using contraception but are subsequently found to have a positive urine pregnancy test (pregnancy test performed as soon as reasonably practicable after IMP administration)
13. Contraindication to cardiac MRI:
13.1. Pacemaker
13.2. Implantable defibrillator
14. Patients unable to undergo cardiac MRI for any of the following reasons:
14.1. Frailty - as judged by the clinician. Frailty is defined as meeting three out of the five following criteria: low grip strength, low energy, slowed walking speed, low physical activity and/or unintentional weight loss. Due to the tight time constraints and emergency setting of this trial the clinician cannot test all these parameters and will need to exercise their judgment
14.2. Claustrophobic - patients who cannot take elevators or who are afraid of narrow or enclosed spaces
14.3. Breathlessness - patients who suffer from breathlessness at rest or low exercise level (e.g. while walking on the level)
15. Use of other investigational study drugs within 30 days prior to trial entry (defined as date of randomisation into trial). Co-enrolment with other studies is not allowed
16. Lack of capacity to give initial verbal consent
17. Life expectancy <1 year due to non-cardiac illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infarct size at 12 weeks post-PPCI as measured by cardiac magnetic resonance imaging (MRI).
- Secondary Outcome Measures
Name Time Method <br> 1. Microvascular obstruction after 2-7 days as measured by a single cardiac MRI scan<br> 2. Salvage index after 2-7 days as measured by a single cardiac MRI scan<br> 3. Change in T lymphocyte counts relative to baseline at 5, 15, 30, 60 and 90 minutes post-reperfusion<br> 4. Number of clinical events (death, stroke or myocardial infarction) after 12 months<br>