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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Diabetes Mellitus

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Giulio Stefanini, MD, PhD, MSc; Phone Number: +390282247384; Email: giulio.stefanini@hunimed.eu
• Study Contact Backup: Name: Gennaro Petriello, MD; Phone Number: +390282247007; Email: gennaro.petriello@humanitas.it

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Recruiting
      • Humanitas Research Hospital
      • Contact: Giulio Stefanini, MD, PhD, MSc
      • Contact: Gennaro Petriello, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with non-ST-segment elevation acute coronary syndrome, with or without diabetes mellitus

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Humanitas Hospital, Italy
• Investigators: Study Chair: Giulio Stefanini, MD, PhD, MSc, Humanitas Research Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Anticipated): March 25, 2022
• Study Completion (Anticipated): March 25, 2022

Study Registration Dates

• First Submitted: March 23, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Disease Attributes; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus; Disease Progression; Acute Coronary Syndrome
• Other Study ID Numbers: PROGRESSION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No