Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry) (ITACA)
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| ClinicalTrials.gov Identifier: NCT04691791 |
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Recruitment Status :
Recruiting
First Posted : December 31, 2020
Last Update Posted : March 29, 2021
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| Condition or disease |
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| Congenital Coronary Artery Abnormality |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Years |
| Official Title: | Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry) |
| Actual Study Start Date : | September 1, 2019 |
| Actual Primary Completion Date : | January 31, 2021 |
| Estimated Study Completion Date : | October 31, 2022 |
- Clinical correlates with imaging findings at the cardiac magnetic resonance imaging. [ Time Frame: Up to 3 years from the time of the enrollment ]Chest pain, palpitations, sincope and arrhythmias
- prevalence of congenital anomalies of coronary origin in specific patient subpopulations: 1) in competitive athletes; 2) patients with ventricular ectopic beats [ Time Frame: 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).
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04691791
| Contact: Francesco Bianco, M.D. | +39 071 596 5316 | francesco.bianco@unich.it |
| Italy | |
| Ospedali Riuniti | Recruiting |
| Ancona, Italy | |
| Contact: Francesco Bianco, MD +39 071 596 5316 francesco.bianco@ospedaliriuniti.marche.it | |
| Contact: Valentina Bucciarelli, MD +39 071 596 5316 valentina.bucciarelli@ospedaliriuniti.marche.it | |
| Principal Investigator: | Francesco Bianco, M.D. | Ospedali Riuniti Ancona |
| Responsible Party: | Francesco Bianco, Medical Doctor, ITAB - Institute for Advanced Biomedical Technologies |
| ClinicalTrials.gov Identifier: | NCT04691791 |
| Other Study ID Numbers: |
SIC_001 |
| First Posted: | December 31, 2020 Key Record Dates |
| Last Update Posted: | March 29, 2021 |
| Last Verified: | March 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Congenital Abnormalities |