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
• Status: Recruiting
• 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
• 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
• 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;

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Aneurysm
• Coronary Aneurysm
• Ectasia
• Syndrome

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