Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry)

Completed

• Conditions: Congenital Coronary Artery Abnormality

• Registration Number: NCT04691791
• Lead Sponsor: ITAB - Institute for Advanced Biomedical Technologies

Brief Summary

Italian registry of coronary artery abnormalities diagnosed utilizing cardiac magnetic resonance imaging.

Detailed Description

Congenital coronary anomalies (ACC) are relatively rare heart disease, in which a congenital defect of origin, course, and term, of one or more epicardial cardiac coronary arteries, is recognized. The global prevalence is estimated at around 0.6-0.7% in the general population, where the most frequent ACCs consist of the anomalous origin of the right coronary artery from the left breast (ARCA), with a prevalence of 0.23%; while the anomalous origin from the Sn coronary artery from the right breast (ALCA) would seem to have a prevalence of 0.03%.

ACCs have often been associated with an increased risk of Sudden Cardiac Death (SCD), especially in athletes. In fact, within this population, ACCs are counted as the second most frequent cause of SCD after hypertrophic cardiomyopathy.

In the general population, the risk of sudden death from ALCA is estimated at around 6.3% at 20 years, while for ARCA it is estimated at around 0.2% at 20 years. The estimated incidence in athletes instead recognizes a range that varies between 0.5 and 13 deaths per 100,000.

Although ACC are therefore recognized as a frequent cause of sudden cardiac death, a recent English study, conducted on a population of 11,168 young footballers, showed a significantly lower incidence than expected: only two coronary anomalies, an ALCA and an ARCA, respectively; the prevalence was therefore 0.002%, at least 10 times lower than expected.

The most common manifestations of ACC are chest pain, palpitations, dizziness and syncope, although more than 50% of patients with ACC are asymptomatic. In the past, these anomalies could only be described at autopsy, while thanks to the enormous developments that the different cardiac imaging modalities have undergone in recent years, ACCs can now also be detected non-invasively. The initial diagnosis is echocardiography, but a confirmation method is necessary (CT, MRI, or coronary angiography), moreover most of the time the finding can be completely incidental and found in the course of examinations conducted for another reason.

This Registry will enroll patients from different sites in Italy (who decided to join the registry within the Italian Society of Cardiology) objectives aiming at establishing the clinical and imaging correlates in patients with congenital anomalies of coronary origin, found or confirmed by cardiac magnetic resonance imaging. As secondary endpoint will be observed subpopulations of patients: 1) in competitive athletes; 2) patients with ventricular ectopic beats (Lown class ≥2).

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2020-12-31
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with anomalous origin of the coronaries diagnosed with cardiac magnetic resonance imaging

Exclusion Criteria

• Patients with known ischemic heart disease
• Patients with coronary atherosclerotic disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical correlates with imaging findings at the cardiac magnetic resonance imaging.	Up to 3 years from the time of the enrollment	Chest pain, palpitations, sincope and arrhythmias

Secondary Outcome Measures

Name	Time	Method
prevalence of congenital anomalies of coronary origin in specific patient subpopulations: 1) in competitive athletes; 2) patients with ventricular ectopic beats	Up to 3 years from the time of the enrollment	Prevalence of coronary arteries abnormalities in competitive athletes and patients with ventricular ectopic beats (Lown class ≥ 2).

Trial Locations

Locations (1)

Ospedali Riuniti; 🇮🇹 Ancona, Italy