Coronary Artery Disease Clinical Trial
Official title:
Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus
A total of 100 patients with non-ST-segment elevation acute coronary syndromes with or
without diabetes mellitus will be included. All patients will undergo coronary angiography
with identification of the infarct-related vessel and percutaneous revascularization with
implantation of a stent/scaffold. After revascularization patients will undergo a combined
positron emission tomography (PET)-coronary computed tomography (CT) protocol to quantify
atherosclerotic burden (i.e. plaque volume) and activity (i.e. 18 fluorum-sodium-fluoride
[18FNaF] uptake) in non-infarct related vessels, to assess calcium score (aim 1), and to
quantify the acute results of PCI in the infarct-related vessel (aim 2). At 12-month
follow-up, all patients will repeat longitudinal 18FNaF PET-coronary CT evaluation to
characterize progression of atherosclerosis in the non-infarct related vessels (aim 1) and to
quantify neointimal suppression at the site of the treated coronary segment in the
infarct-related vessel (aim 2). Blood samples will be collected at baseline and 12 months for
all patients.
The aims of the study are:
1. To evaluate coronary artery disease progression in acute coronary syndromes patients
with and without diabetes mellitus, and to investigate the predictive value of metabolic
profiles, patterns of circulating miRNAs and inflammatory mediators on coronary artery
disease progression;
2. To evaluate the progression of disease within the infarct-related vessel treated with
the use of bioresorbable stent/bioresorbable polymer stents in diabetic and non-diabetic
patients with acute coronary syndromes.
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