None listed
Conditions
Brief summary
Cardiovascular disease remains a leading cause of morbidity and mortality in the developed world. Patients who have heart attacks remain the highest risk group, with up to 30% dying or having a further event in 3 years and improved methods of risk stratification are urgently needed. Intra-coronary optical coherence tomography (OCT) is a modality based on near infrared spectrum light with a superior resolution of the high risk components of coronary plaque. We hypothesise that coronary OCT imaging at the time of routine coronary revascularisation when combined with computational methods will be superior to conventional risk scores in predicting future major adverse cardiovascular events. Patients admitted with a Non ST elevation Myocardial Infarction (NSTEMI) and who proceed to inpatient angiography or a ST Elevation Myocardial Infarction (STEMI) and who proceed to non-emergency in-patient angiography or stable/unstable angina may be eligible to participate in the study. The study aims to 1) to determine the predictive value of high risk plaque on OCT for patient oriented clinical events (POCE: recurrent myocardial infarction, coronary revascularisation or death). 2) to determine the predictive value of OCT derived low endothelial shear stress for recurrent POCE. 3) To determine the predictive value of OCT derived high endothelial shear stress for recurrent myocardial infarction and death 4) To develop a multivariate model for predicting residual risk based on multiple imaging parameters and determine its incremental predictive power when added to clinical risk factors and existing risk scores (eg. GRACE-score, Syntax score, Clinical Syntax score).
Interventions
All patients undergoing coronary angiography and angioplasty in the study will have optical coherence tomography (OCT) imaging performed on the proximal 5cm of at least 2 of the 3 major epicardial arteries. The OCT catheter is positioned over a guide wire after the angioplasty procedure and is mostly used to optimise stunting procedures. After imaging the stunted after at least one (to maximum 2) additional arteries will also be imaged. The additional OCT imaging will add approximately 5-10 mi
All patients undergoing coronary angiography and angioplasty in the study will have optical coherence tomography (OCT) imaging performed on the proximal 5cm of at least 2 of the 3 major epicardial arteries. The OCT catheter is positioned over a guide wire after the angioplasty procedure and is mostly used to optimise stunting procedures. After imaging the stunted after at least one (to maximum 2) additional arteries will also be imaged. The additional OCT imaging will add approximately 5-10 minutes to procedure duration and will increase the volume of radiographic contrast used by a small amount, approximately 30 ml.
Sponsors
Abbott Vascular
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who present to hospital with (1a) NSTEMI and who proceed to inpatient angiography or (1b) STEMI and who proceed to non-emergency in-patient angiography (late presenters, reperfused without PCI; patients who return to the catheter laboratory for in-patient treatment of non-infarct related additional coronary stenosis following initial primary PCI) or (1c) stable or unstable angina. 2. One or more functionally significant coronary lesion where PCI is deemed appropriate 3. Age 18 to 85 years old 4. At least 2 major epicardial coronary arteries (left anterior descending, left circumflex, right coronary arteries) suitable for per protocol OCT.
Exclusion criteria
1. eGFR less than 40ml/min 2. Unlikely to survive for at least 3 years due to comorbidity 3. Coronary anatomy unsuitable for OCT 4. Pregnancy 5. Prior Coronary Artery Bypass Graft (CABG) 6. At the time of acute presentation with STEMI treated with primary PCI (see inclusion criteria 1b) 7. Refractory heart failure 8. Known significant non-compliance with medication
Outcome results
None listed