Observational registry for patients with acute coronary syndrome and coronary aneurysms or ectasia
ITAlian Coronary Artery Aneurysm and Ectasia Observational Study in Patients With Acute Coronary Syndrome: The ITACA Registry
This study is looking at how patients with Acute Coronary Syndrome and coronary aneurysms or ectasia respond to different treatments to better understand their health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 2 sites (Forlì, FC and 1 other locations) |
| Trial ID | NCT05051917 on ClinicalTrials.gov |
What this trial studies
The ITACA study is a prospective, observational registry that enrolls patients diagnosed with Acute Coronary Syndrome (ACS) who also have angiographic evidence of coronary aneurysms and/or ectasia. The study aims to evaluate both short and long-term outcomes for these patients, collecting data on the safety and effectiveness of various invasive and pharmacological treatment strategies. By analyzing this data, the study seeks to enhance understanding of the implications of coronary artery abnormalities in the context of ACS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with acute coronary syndrome and have angiographic evidence of coronary aneurysms or ectasia.
Not a fit: Patients who may not benefit from this study include those with contraindications to dual antiplatelet or anticoagulant therapy, active bleeding, severe anemia, or a life expectancy of less than 12 months.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management and treatment of patients with acute coronary syndrome and coronary artery abnormalities.
How similar studies have performed: Other studies have explored similar conditions, but the specific focus on coronary aneurysms and ectasia in the context of acute coronary syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Forlì, FC and 1 other locations
- Giuseppe Tarantino — Forlì, Fc, Italy (Recruiting)
- Professor Giovanni Esposito — Naples, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.