NCT03890822

Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Humanitas Hospital, Italy · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Artery Disease
• Diabetes Mellitus

Timeline

• Start date: 2019-03-25
• Primary completion: 2022-03-25
• Completion: 2022-03-25
• First posted: 2019-03-26
• Last updated: 2019-05-07

Locations

1 site across 1 country: Italy