Congenital Coronary Artery AbnormalityITACANCT04691791
Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry)
An observational study of Congenital Coronary Artery Abnormality, run by ITAB - Institute for Advanced Biomedical Technologies at 1 site in Italy.
Trial summary
Italian registry of coronary artery abnormalities diagnosed utilizing cardiac magnetic resonance imaging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Coronary Artery Abnormality
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 31 Oct 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with anomalous origin of the coronaries diagnosed with cardiac magnetic resonance imaging
Who cannot join
- Patients with known ischemic heart disease
- Patients with coronary atherosclerotic disease
Trial locations and contacts
1 site in 1 country.
About this study
Italian registry of coronary artery abnormalities diagnosed utilizing cardiac magnetic resonance imaging.
Read the 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).
- Conditions
- Congenital Coronary Artery Abnormality
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical correlates with imaging findings at the cardiac magnetic resonance imaging.
Chest pain, palpitations, sincope and arrhythmias
Measured: Up to 3 years from the time of the enrollment
Secondary outcomes (1)
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).
Measured: Up to 3 years from the time of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Sep 2019
- Primary completion30 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Congenital Coronary Artery AbnormalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- ITAB - Institute for Advanced Biomedical Technologies
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Society of Cardiology
- Responsible party
- Principal investigator, Francesco Bianco, ITAB - Institute for Advanced Biomedical Technologies
- Investigators
- Francesco Bianco, M.D., Principal investigator, Ospedali Riuniti Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691791
- Sponsor's protocol ID
- SIC_001
- Acronym
- ITACA
- Status last verified
- Mar 2023
- First submitted
- 28 Dec 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28335843Brothers 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 4. No abstract available.
PubMed 28274557Eckart 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: 10.7326/0003-4819-141-11-200412070-00005.
PubMed 15583223Basso 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/s0735-1097(00)00566-0.
PubMed 10807452Maron 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.
PubMed 19221222Malhotra 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.
PubMed 30089062Villa 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.
PubMed 27358682
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries (ITACA-Registry)
- ClinicalTrials.gov ID
- NCT04691791
- Acronym / sponsor ID
- ITACA / SIC_001
- Conditions
- Congenital Coronary Artery Abnormality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ITAB - Institute for Advanced Biomedical TechnologiesUniversity, hospital or other
- Collaborators
- Italian Society of Cardiology
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with anomalous origin of the coronaries diagnosed with cardiac magnetic resonance imaging
Key exclusion criteria (2 listed)
- Patients with known ischemic heart disease
- Patients with coronary atherosclerotic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Results publication: PubMed 28335843Cheezum 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.
- Results publication: PubMed 28274557Brothers 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 4. No abstract available.
- Results publication: PubMed 15583223Eckart 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: 10.7326/0003-4819-141-11-200412070-00005.
- Results publication: PubMed 10807452Basso 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/s0735-1097(00)00566-0.
- Results publication: PubMed 19221222Maron 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.
- Results publication: PubMed 30089062Malhotra 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.
- Results publication: PubMed 27358682Villa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Bianco, M.D. principal investigator
Ospedali Riuniti Ancona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Coronary Artery Abnormality, run by ITAB - Institute for Advanced Biomedical Technologies at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical correlates with imaging findings at the cardiac magnetic resonance imaging. (time frame: Up to 3 years from the time of the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691791, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.