Coronary Artery Disease clinical trials at UCSD

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

The aim of the TARGET-IV NA trial is to demonstrate the clinical non-inferiority of the Firehawk® rapamycin eluting stent system in comparison to currently approved 2nd generation DES for the treatment of subjects with ischemic heart disease (NSTEMI, recent STEMI (>24 hours from initial presentation and in whom enzyme levels have peaked), unstable angina, and stable coronary disease), with atherosclerotic target lesion(s) in coronary arteries with visually estimated reference vessel diameters ≥2.25 mm and ≤4.0 mm.

The purpose of this study is to see if reducing the number of hours during which one eats each day will help reduce levels of LDL cholesterol and improve other markers of metabolic and cardiovascular health (i.e. blood sugar levels and blood pressure). The study also aims to assess changes in exercise capacity and trimethylamine N-oxide (TMAO) levels in response to Time Restricted Eating (TRE) and Intensive Cardiac Rehabilitation (ICR) versus ICR alone. TMAO is a metabolite, or a substance, produced during digestion and metabolism. Preliminary data illustrates a correlation between high levels of TMAO and higher risk of cardiovascular disease and mortality. We will also be looking at participants' long-term cardiovascular health status after they complete the ICR program.

This retrospective study will evaluate the coronary angiograms of approximately 100 patients who have undergone invasive angiography and fractional flow reserve (FFR). DICOM files of the angiograms will be analyzed on a secure computer within the cardiac catheterization laboratory using the AutocathFFR software to assess if invasive FFR measurements and automated computer analysis of FFR measurements correlate. AutocathFFR measurement per lesion will be compared to the gold standard, invasive FFR value, where an FFR ≤ 0.80 will be considered "positive", while an FFR > 0.8 will be considered "negative". The AutocathFFR value will be compared to the invasive FFR measurements. The sensitivity and specificity of the AutocathFFR will be calculated, as well as the AutocathFFR accuracy, positive predictive value and negative predictive value per lesion. Device success will be calculated as the ratio of completed versus initiated AutocathFFR index calculations. Usability of the AutocathFFR software will be evaluated using dedicated questionnaires to be completed by the user (cardiologists).