NCT06775639 Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD Patients?
| NCT ID | NCT06775639 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Adult Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2025-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-01-08 with a primary completion date of 2025-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)?
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
Contact & Investigator
Gabriele Egidy Assenza, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06775639 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adult Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06775639 currently recruiting?
Yes, NCT06775639 is actively recruiting participants. Contact the research team at gabriele.egidyassenza@aosp.bo.it for enrollment information.
Where is the NCT06775639 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06775639 clinical trial?
NCT06775639 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Gabriele Egidy Assenza, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 80 participants.