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NCT05051917 Clinical Trial

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

Acute Coronary Syndrome Clinical Trial

— ITACA  

Official title:
ITAlian Coronary Artery Aneurysm and Ectasia Observational Study in Patients With Acute Coronary Syndrome: The ITACA Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05051917
Other study ID # 22/21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2026

Study information
Verified date February 2024
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date September 1, 2026
Est. primary completion date September 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Giuseppe Tarantino Forlì FC
Italy Professor Giovanni Esposito Naples

Sponsors (2)
Lead Sponsor Collaborator
Federico II University Fondazione GISE Onlus

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cardiac events A composite endpoint of myocardial infarction, stroke, cardiovascular death, myocardial revascularization and hospitalisation due to cardiovascular events two years
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