Clinical trial NCT06775639: Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD Patients?
Official title: Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD (Adult Congenital Heart Disease) Patients? The SPARE Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Congenital Heart Disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Non-significant and significant coronary lesions
timeFrame: Immediately after the procedure
measure: Coronary tree partially or completely unassessable for artifacts or extensive calcifications that prevent proper evaluation
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Side effects/complications from administration of iodinated contrast medium for the performance of Coronary Computer Tomography (CCT) or Invasive CoronaryAngiography (ICA)
timeFrame: Within 48 hours of the investigation.
measure: 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
timeFrame: At the end of CCT and ICA
measure: 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
timeFrame: during the procedure
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Gabriele Egidy Assenza, MD
role: PRINCIPAL_INVESTIGATOR
References: