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

Congenital Coronary Artery Abnormality Clinical Trial

— ITACA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691791
• Other study ID #: SIC_001
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2023
• Source: ITAB - Institute for Advanced Biomedical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Congenital Coronary Artery Abnormality

Locations

Country	Name	City	State
Italy	Ospedali Riuniti	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
ITAB - Institute for Advanced Biomedical Technologies	Italian Society of Cardiology

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Basso C, Maron BJ, Corrado D, Thiene G. Clinical profile of congenital coronary artery anomalies with origin from the wrong aortic sinus leading to sudden death in young competitive athletes. J Am Coll Cardiol. 2000 May;35(6):1493-501. doi: 10.1016/s0735- — View Citation

Brothers JA, Frommelt MA, Jaquiss RDB, Myerburg RJ, Fraser CD Jr, Tweddell JS. Expert consensus guidelines: Anomalous aortic origin of a coronary artery. J Thorac Cardiovasc Surg. 2017 Jun;153(6):1440-1457. doi: 10.1016/j.jtcvs.2016.06.066. Epub 2017 Feb — View Citation

Cheezum MK, Liberthson RR, Shah NR, Villines TC, O'Gara PT, Landzberg MJ, Blankstein R. Anomalous Aortic Origin of a Coronary Artery From the Inappropriate Sinus of Valsalva. J Am Coll Cardiol. 2017 Mar 28;69(12):1592-1608. doi: 10.1016/j.jacc.2017.01.031 — View Citation

Eckart RE, Scoville SL, Campbell CL, Shry EA, Stajduhar KC, Potter RN, Pearse LA, Virmani R. Sudden death in young adults: a 25-year review of autopsies in military recruits. Ann Intern Med. 2004 Dec 7;141(11):829-34. doi: 10.7326/0003-4819-141-11-2004120 — View 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 Car — View Citation

Maron BJ, Doerer JJ, Haas TS, Tierney DM, Mueller FO. Sudden deaths in young competitive athletes: analysis of 1866 deaths in the United States, 1980-2006. Circulation. 2009 Mar 3;119(8):1085-92. doi: 10.1161/CIRCULATIONAHA.108.804617. Epub 2009 Feb 16. — View Citation

Villa AD, Sammut E, Nair A, Rajani R, Bonamini R, Chiribiri A. Coronary artery anomalies overview: The normal and the abnormal. World J Radiol. 2016 Jun 28;8(6):537-55. doi: 10.4329/wjr.v8.i6.537. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical correlates with imaging findings at the cardiac magnetic resonance imaging.	Chest pain, palpitations, sincope and arrhythmias	Up to 3 years from the time of the enrollment
Secondary	prevalence of congenital anomalies of coronary origin in specific patient subpopulations: 1) in competitive athletes; 2) patients with ventricular ectopic beats	Prevalence of coronary arteries abnormalities in competitive athletes and patients with ventricular ectopic beats (Lown class = 2).	Up to 3 years from the time of the enrollment