Clinical trial NCT03890822: Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus
Official title: Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Diabetes Mellitus
Lead sponsor: Humanitas Hospital, Italy
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-ST-segment elevation acute coronary syndrome, with or without diabetes mellitus

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentual atheroma volume
timeFrame: 12 months
measure: Minimal lumen area
timeFrame: 12 months
Secondary outcomes:
measure: Percentual change in 18FNaF uptake
timeFrame: 12 months
measure: Change in minimal lumen area
timeFrame: 12 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
affiliation: Humanitas Research Hospital IRCCS
name: Giulio Stefanini, MD, PhD, MSc
role: STUDY_CHAIR
References: