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

NCT ID: NCT03890822

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2022-03-25

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Humanitas Hospital, Italy

OTHER

Sponsor Role: lead

Responsible Party

Giulio Stefanini

Head of Clinical Research, Cardio Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giulio Stefanini, MD, PhD, MSc

Role: STUDY_CHAIR

Humanitas Research Hospital IRCCS

Locations

Humanitas Research Hospital

Rozzano, Milan, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giulio Stefanini, MD, PhD, MSc

Role: CONTACT

giulio.stefanini@hunimed.eu

+390282247384

Gennaro Petriello, MD

Role: CONTACT

gennaro.petriello@humanitas.it

+390282247007

Facility Contacts

Giulio Stefanini, MD, PhD, MSc

Role: primary

Gennaro Petriello, MD

Role: backup

Other Identifiers

PROGRESSION

Identifier Type: -

Identifier Source: org_study_id