Clinical trial NCT04691791: Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry)
Official title: Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Coronary Artery Abnormality
Lead sponsor: ITAB - Institute for Advanced Biomedical Technologies
Sponsor class: OTHER
Collaborators: name: Italian Society of Cardiology
First posted: 2020-12-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing cardiac magnetic resonance imaging who have expressed informed consent to data processing, who have a set of images from which the anomalous origin of the coronaries can be diagnosed.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Clinical correlates with imaging findings at the cardiac magnetic resonance imaging.
timeFrame: Up to 3 years from the time of the enrollment
Secondary outcomes:
measure: prevalence of congenital anomalies of coronary origin in specific patient subpopulations: 1) in competitive athletes; 2) patients with ventricular ectopic beats
timeFrame: Up to 3 years from the time of the enrollment
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Ospedali Riuniti
Study officials:
affiliation: Ospedali Riuniti Ancona
name: Francesco Bianco, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Malhotra A, Dhutia H, Finocchiaro G, Gati S, Beasley I, Clift P, Cowie C, Kenny A, Mayet J, Oxborough D, Patel K, Pieles G, Rakhit D, Ramsdale D, Shapiro L, Somauroo J, Stuart G, Varnava A, Walsh J, Yousef Z, Tome M, Papadakis M, Sharma S. Outcomes of Cardiac Screening in Adolescent Soccer Players. N Engl J Med. 2018 Aug 9;379(6):524-534. doi: 10.1056/NEJMoa1714719.
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