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

NCT03890822 | Unknown

• 1 other identifier: PROGRESSION
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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. 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

Outcome Measures

Primary Outcomes (2)

• Percentual atheroma volume

  Assessed by CT

  12 months

• Minimal lumen area

  Assessed by CT

  12 months

Secondary Outcomes (2)

• Percentual change in 18FNaF uptake

  12 months

• Change in minimal lumen area

  12 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age \>18 and \<80 years, evidence of non-ST-segment elevation acute coronary syndromes, ability to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanitas Hospital, Italy: lead

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Giulio Stefanini, MD, PhD, MSc

  Humanitas Research Hospital IRCCS

  STUDY CHAIR

Central Study Contacts

Giulio Stefanini, MD, PhD, MSc

CONTACT

+390282247384; giulio.stefanini@hunimed.eu

Gennaro Petriello, MD

CONTACT

+390282247007; gennaro.petriello@humanitas.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Research, Cardio Center

Study Record Dates

• First Submitted: March 23, 2019
• First Posted: March 26, 2019
• Study Start: March 25, 2019
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

IT (1)