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

Sponsor
ITAB - Institute for Advanced Biomedical Technologies (Other)
Overall Status
Recruiting
CT.gov ID
NCT04691791
Collaborator
Italian Society of Cardiology (Other)
100
1
38
2.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry)
    Actual Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ospedali Riuniti Ancona Italy

    Sponsors and Collaborators

    • ITAB - Institute for Advanced Biomedical Technologies
    • Italian Society of Cardiology

    Investigators

    • Principal Investigator: Francesco Bianco, M.D., Ospedali Riuniti Ancona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Francesco Bianco, Medical Doctor, ITAB - Institute for Advanced Biomedical Technologies
    ClinicalTrials.gov Identifier:
    NCT04691791
    Other Study ID Numbers:
    • SIC_001
    First Posted:
    Dec 31, 2020
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022