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

NCT ID: NCT06775639

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2025-05-01

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.

Conditions

Adult Congenital Heart Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriele Egidy Assenza, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gabriele Egidy Assenza, MD

Role: CONTACT

gabriele.egidyassenza@aosp.bo.it

+39 051 2149072

Facility Contacts

Gabriele Egidy Assenza, MD

Role: primary

gabriele.egidyassenza@aosp.bo.it

+390512149072

Other Identifiers

SPARE

Identifier Type: -

Identifier Source: org_study_id