Background Remote ischaemic conditioning (rIC) is a cardioprotective tool which has shown promise in preclinical and clinical trials in the context of acute ischaemia. Repeated rIC post myocardial infarction may provide additional benefits which have not previously been tested clinically.
Methods The trial assessed the role of daily rIC in enhancing left ventricular ejection fraction (LVEF) recovery in patients with impaired LVEF (<45%) after ST segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (P-PCI). Patients were recruited from four UK hospitals and randomised to receive either 4 weeks of daily rIC or sham conditioning using the autoRIC Device (CellAegis) starting on day 3 post P-PCI. The primary endpoint was the improvement in LVEF over 4 months assessed by cardiac MRI (CMR). Seventy-three patients (38 cases, 35 controls) completed the study.
Results The treatment and control groups were well matched at baseline including for mean LVEF (42.8% vs 44.3% respectively, p=0.952). There was no difference in the improvement in LVEF over 4 months between the treatment and control groups (4.8%±7.8% vs 4.6%±5.9% respectively, p=0.924). No differences were seen in the secondary outcome measures including changes in infarct size and left ventricular end-diastolic and systolic volumes, major adverse cardiac and cerebral event, mean Kansas City Cardiomyopathy Questionnaire score and change in N-terminal pro-brain natriuretic peptide levels.
Conclusions Daily rIC starting on day 3 and continued for 4 weeks following successful P-PCI for STEMI did not improve LVEF as assessed by CMR after 4 months when compared with a matched control group.
Trial registration number NCT0166461.
- heart failure
- primary percutaneous coronary intervention
- remote ischaemic conditioning
- ST elevation myocardial infarction
- ventricular remodelling
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Contributors APV conceived and designed the trial and drafted the manuscript. NJS provided overall supervision and was the chief investigator. All other authors were involved in either recruitment of participants or analysis of CMR or secondary outcome investigation results. All authors were involved in the final draft of the manuscript. NJS acts as the guarantor for the overall content of the work.
Funding This research received financial support from the NIHR Leicester Cardiovascular Biomedical Research Unit and the Masonic Charitable Foundation.
Competing interests None declared.
Patient consent Not required.
Ethics approval NHS Research Authority-NRES Committee East Midlands-Northhampton.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The original data to all the results outlined in the manuscript can be provided in raw format on request in an anonymised form.
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