NCT06775639

Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD Patients?

Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD (Adult Congenital Heart Disease) Patients? The SPARE Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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)?

Detailed description

The primary aim is to verify the diagnostic reliability of coronary CCT to confirm or exclude the presence of significant coronary artery disease in ACHD patients who are candidates for cardiac surgery compared to ICA, the current gold standard. the Secondary objectives is to measure the occurrence of side effects and/or complications secondary to ICA and CCT procedures. To measure the frequency with which each of the two methods is able to identify the presence of coronary anomaly and the correct anatomical relationships between the anomalous coronary artery and the adjacent structures. To compare the waiting times of coronary CCT and coronarography, in order to assess their actual availability in daily clinical practice. The primary outcomes of the study are: * non-significant lesions of the coronary tree (stenosis \< 50%) * significant lesions (stenosis ≥ 50%) * limited to CCT investigation: coronary tree partially or completely unassessable due to artefacts or extensive calcifications preventing proper assessment.

Conditions

• Adult Congenital Heart Disease

Timeline

• Start date: 2025-01-08
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2025-01-15
• Last updated: 2025-01-15

Locations

1 site across 1 country: Italy