The Italian Coronary Artery Aneurysm and Ectasia In Patients With Acute Coronary Syndrome

Recruiting

• Conditions: Acute Coronary Syndrome; Ectasia; Angiographic Evidence if Coronary Aneurysms

• Registration Number: NCT05051917
• Lead Sponsor: Federico II University

Brief Summary

The ITACA study is a prospective, observational no profit registry enrolling patients with Acute Coronary Syndrome and angiographic evidence of coronary aneurysms and/or ectasia.

Detailed Description

The ITACA study is aimed at evaluating short and long term outcomes in patients with acute coronary sindrome and angiographic evidence of coronary aneurysm and/or actasia. Data regarding safety and effectiveness of invasive and pharmacological treatment strategies will be also collected.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Study First Posted: 2021-09-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2024-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Signature of informed consent;
• Patients aged ≥18 years;
• diagnosis of ACS (ST-elevation myocardial infarction, non ST-elevation myocardial infarction, unstable angina), in accordance with the definition provided in the latest guidelines;
• diagnosis of ectasia or coronary aneurysm according to the definitions contained in this protocol, either in the culprit vessel of the SCA than in another vessel. Coronary pseudoaneurysms are excluded.

Exclusion Criteria

• impossibility or unwillingness to provide signed informed consent;
• contraindications to dual antiplatelet therapy;
• contraindications to anticoagulant therapy;
• active bleeding or severe anemia (Hb <6 g / dl);
• life expectancy <12 months;
• female patients with potential pregnancy;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	two years	A composite endpoint of myocardial infarction, stroke, cardiovascular death, myocardial revascularization and hospitalisation due to cardiovascular events

Trial Locations

Locations (2)

Giuseppe Tarantino; 🇮🇹 Forlì, FC, Italy

Professor Giovanni Esposito; 🇮🇹 Naples, Italy