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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03890822

Acronym

PROGRESSION

Enrollment

100

Registered

2019-03-26

Start date

2019-03-25

Completion date

2022-03-25

Last updated

2019-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Minimal lumen area	12 months	Assessed by CT
Percentual atheroma volume	12 months	Assessed by CT

Secondary

Measure	Time frame
Percentual change in 18FNaF uptake	12 months
Change in minimal lumen area	12 months

Countries

Italy

Contacts

Primary ContactGiulio Stefanini, MD, PhD, MSc

giulio.stefanini@hunimed.eu+390282247384

Backup ContactGennaro Petriello, MD

gennaro.petriello@humanitas.it+390282247007

Outcome results