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Recruiting Observational

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

NCT06775639 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-08
Last updated
2025-01-15

Condition(s) studied

Adult Congenital Heart Disease

Study 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)?

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Non-significant and significant coronary lesions — Immediately after the procedure
    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 — immediately after the procedure
    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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06775639 on ClinicalTrials.gov ↗ ← All trials in Italy