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

Coronary Artery Disease Clinical Trial

— PROGRESSION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03890822
• Other study ID #: PROGRESSION
• Status: Recruiting
• Start date: March 25, 2019
• Est. completion date: March 25, 2022

Study information

• Verified date: May 2019
• Source: Humanitas Hospital, Italy
• Contact: Giulio Stefanini, MD, PhD, MSc
• Phone: +390282247384
• Email: giulio.stefanini[@]hunimed.eu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Disease Progression
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Hospital, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentual atheroma volume	Assessed by CT	12 months
Primary	Minimal lumen area	Assessed by CT	12 months
Secondary	Percentual change in 18FNaF uptake		12 months
Secondary	Change in minimal lumen area		12 months