The OXAMI study is a prospective single centre observational cohort study of patients with suspected or known coronary artery disease, including acute myocardial infarction, who present for coronary angiography with the usual expectation of proceeding to PCI. Patients undergoing coronary angiography with the possibility of proceeding to PCI, but in whom no PCI is performed, will also be included as control subjects.
The overall objective is to develop, validate and test the utility of new tools for the characterisation of coronary artery disease and acute myocardial infarction. The validation of biomarkers (below) will come from the context of a near-comprehensive cohort that is carefully worked up and followed prospectively for both (1) clinical events and (2) recognised surrogates e.g. scar size and LV ejection fraction.
- To evaluate the utility of individual biomarkers in the assessment of coronary artery disease and myocardial infarction. Individual biomarkers include:
- Blood components derived substances (from cells, DNA, plasma, etc.)
- Angiographic and Intravascular plaque imaging characteristics
- Myocardial imaging of cardiac function and injury
- Cardiac and Coronary flow/pressures and microcirculation parameters
- To evaluate the relationship of clinical procedures and techniques to biomarkers and clinical outcomes.
- To evaluate clinical and patient-reported outcomes after myocardial infarction and/or PCI.
Summary of Study Design:
Patients, age 30-90, are included in the study. In non-emergency settings, informed consent will be obtained prior to the angiography or PCI procedure. The procedure for consent in patients undergoing emergency procedures complies with the Mental Capacity Act and involves a patient “advocate” who witnesses a verbal consent process for all conscious potential participants. This is followed by full written consent once the emergency phase is over.
The PCI procedure is undertaken in a standard fashion, and may include the use of OCT and/or IVUS imaging and/or coronary flow/pressure measurements before and/or after stent deployment. Aspiration devices or protection may be used where vessel anatomy is suitable. The devices used and the procedural techniques are driven by clinical decision making at the patient and institutional level, and carried out in accordance with the Oxford University Hospitals NHS Trust (OUHT) departmental guidelines for PCI. Blood sampling from targeted anatomical sites, ECG recording, and other follow up imaging is carried out at specific time points. Cardiovascular MRI is undertaken both before and at time points after the PCI procedure. Participants are invited to return for outpatient/day case assessment at 1-2 and/or 6 months after the index PCI procedure, and will be followed up clinically thereafter at yearly intervals.
The study investigators are funded by the University of Oxford, the British Heart Foundation,the OUH NHS Trust and the NIHR Oxford Biomedical Research Centre. Further funding for specific sub-projects has been obtained from the British Heart Foundation and St. Jude Medical. The Clinical Research Network-Thames Valley and South Midlands provides additional nursing support.
The study is sponsored by the University of Oxford (Ethics Ref: 11/SC0397).
See Patient Information Leaflet OXAMI PIL_Heart attack