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

NCT05051917 | Recruiting DMC

• 1 other identifier: 22/21
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome; Angiographic Evidence if Coronary Aneurysms; Ectasia

Keywords

Aute Coronary Syndrome; Coronary Artery Artery; Ectasia

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events

  A composite endpoint of myocardial infarction, stroke, cardiovascular death, myocardial revascularization and hospitalisation due to cardiovascular events

  two years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing coronary angiography with diagnosis of ACS and contextual detection of coronary ectasia or aneurysm in accordance with the definitions specified below. Patients with coronary pseudoaneurysms are excluded.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federico II University: lead
• Fondazione GISE Onlus: collaborator

Study Sites (2)

Giuseppe Tarantino

Forlì, FC, 47121, Italy

RECRUITING

Professor Giovanni Esposito

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 21, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)