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

• Conditions: Diabetes Mellitus; Coronary Artery Disease

• Registration Number: NCT03890822
• Lead Sponsor: Humanitas Hospital, Italy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-23
• Study Start: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-07
• Primary Completion: 2022-03-25
• Study Completion: 2022-03-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age >18 and <80 years, evidence of non-ST-segment elevation acute coronary syndromes, ability to provide informed consent

Exclusion Criteria

• ST-segment elevation myocardial infarction, cardiogenic shock, suspected stent thrombosis, known allergy to aspirin or ticagrelor, childbearing potential, life expectancy <1 year due to non-cardiac disease, severe chronic kidney disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentual atheroma volume	12 months	Assessed by CT
Minimal lumen area	12 months	Assessed by CT

Secondary Outcome Measures

Name	Time	Method
Change in minimal lumen area	12 months
Percentual change in 18FNaF uptake	12 months

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy