About this trial
The goal of this observational study is to compare two pre-operative methods, that is the Invasive Coronary Angiography (ICA), an actual standard diagnostic method, with the Coronary Computer Tomography (CCT) to undestand if the only CCT is sufficent to confirm the presence of a significative coronary disease and so to identify possible lesions in the coronary ematic circle, for example: stenosis and narrowing of coronary vessels. This observational study included people who have a congenital heart desease with indication of cardiac surgery and, why this disease, who had already performed these two diagnostic methods and/or who will perform them. The main question it aims to answer is: Should we avoid performing invasive coronary angiography (ICA) before cardiac surgery in people who have congenital heart desease (ACHD patients)?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult congenital heart disease patient who is a candidate for cardiac surgery for correction of defect valve, or who performed the surgery after 01.01.2010
Clinical indication for preoperative ICA and CCT performed less than 12 months apart within 12 months of planned cardiac surgery
Age ≥ 18 years
Obtaining written informed consent
Disqualifiers
Inability to perform ICA for any reason (e.g., poor vascular access or anatomical difficulty in reaching the coronary arteries)
Patient with severe renal failure on dialysis therapy
Patient with previous cerebri stroke
Trial population
The study will include ACHD patients referred to the Pediatric Cardiology and Cardiac Surgery of the Cardiology Operating Unit of the IRCCS AOU of Bologna, candidates for surgery cardiac surgery with clinical indication to undergo preoperative ICA and CCT. The SPARE study will include only patients with independent clinical indication to CCT.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Non-significant and significant coronary lesions
Coronary lesions will be defined as nonsignificant when they result in a narrowing of the lumen of the coronary artery less than 50%. Lesions will be considered significant when they will result in a narrowing of the lumen of the coronary artery equal to or greater than 50%.
Coronary tree partially or completely unassessable for artifacts or extensive calcifications that prevent proper evaluation
A portion or the entire coronary tree will be defined as unassessable when it is not it is possible to determine the percentage of stenosis in a coronary segment or in the entire coronary artery.
Secondary outcomes
Side effects/complications from administration of iodinated contrast medium for the performance of Coronary Computer Tomography (CCT) or Invasive CoronaryAngiography (ICA)
Creatininemia elevation of 0.3 mg/dl within 48 hours after surgery, or more than 150% of the initial value or a reduction of diuresis below 0.5 ml/Kg for more than 6 hours. Incidence of cardiac death, heart attack myocardial infarction, stroke, vascular complications and nonvascular at the site of access ie. finding of vascular aneurysm or pseudoaneurysm or obstruction of the artery used for ICA, major bleeding defined as of grade 3 or higher according to the BARC classification.
Identification of abnormal origin from the aortic wall of any of the three major coronary arteries (right coronary artery, anterior interventricular branch, branch circumflex); identification of a different than normal course of any of the three main
Abnormal origin: finding of abnormal position compared to the normal anatomical position of the ostium of at least one of the coronary arteries (right coronary artery, common trunk or anterior interventricular branch and branch circumflex). Abnormal course: different than normal course of one of the three major arteries coronary arteries. Dangerous course: course through the large vessels (aorta and pulmonary artery or other paracardiac) of one of the three major coronary arteries.
Waiting time for the execution of the of the investigation defined as: time that elapses between the decision to perform CCT and the preoperative ICA
Interval of time between the decision of the execution of the investigation and the date on which the investigation is conducted
Sponsors and contacts
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