Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691791
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2020-12-28
Brief Title:
Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries ITACA-Registry
Sponsor:
ITAB - Institute for Advanced Biomedical Technologies
Organization:
ITAB - Institute for Advanced Biomedical Technologies
Study Overview
Official Title:
Italian Registry of Cardiovascular Magnetic Resonance on Congenital Anomalies of the Coronary Arteries ITACA-Registry
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITACA
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 06-07 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 023 while the anomalous origin from the Sn coronary artery from the right breast ALCA would seem to have a prevalence of 003
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 63 at 20 years while for ARCA it is estimated at around 02 at 20 years The estimated incidence in athletes instead recognizes a range that varies between 05 and 13 deaths per 100000
Although ACC are therefore recognized as a frequent cause of sudden cardiac death a recent English study conducted on a population of 11168 young footballers showed a significantly lower incidence than expected only two coronary anomalies an ALCA and an ARCA respectively the prevalence was therefore 0002 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
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 63 at 20 years while for ARCA it is estimated at around 02 at 20 years The estimated incidence in athletes instead recognizes a range that varies between 05 and 13 deaths per 100000
Although ACC are therefore recognized as a frequent cause of sudden cardiac death a recent English study conducted on a population of 11168 young footballers showed a significantly lower incidence than expected only two coronary anomalies an ALCA and an ARCA respectively the prevalence was therefore 0002 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None