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NCT Number: NCT05051917

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Giuseppe Tarantino, Forlì, FC, Italy

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Major adverse cardiac events

    Time frame: two years

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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • Fondazione GISE Onlus

Registry information

Official study title

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

Acronym: ITACA

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Sep 21, 2021
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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