Actively Recruiting
Should We Avoid Invasive Coronary Angiography Before Cardiac Surgery in Adults with Congenital Heart Disease? An Observational Study Comparing Coronary Computer Tomography and Angiography
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-15
80
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two pre-operative diagnostic methods for adults with congenital heart disease (ACHD) who are candidates for cardiac surgery. The study compares Invasive Coronary Angiography (ICA), the current standard, with Coronary Computer Tomography (CCT) to determine if CCT alone can reliably identify significant coronary artery disease, such as stenosis or narrowing of coronary vessels. The main question is whether ICA can be avoided before cardiac surgery in ACHD patients. The study observes patients who have undergone or will undergo both ICA and CCT within 12 months prior to their planned cardiac surgery. It measures the diagnostic reliability of CCT compared to ICA, evaluating the presence of significant and non-significant coronary lesions. Secondary objectives include assessing side effects or complications from both procedures, identifying coronary anomalies and their anatomical relationships, and comparing the waiting times for CCT and ICA to assess their availability in clinical practice. Participants will be adults with ACHD scheduled for cardiac surgery or who had surgery after January 1, 2010. The study looks at the immediate results after each procedure, focusing on coronary lesions and the quality of imaging. Researchers will monitor for any complications and evaluate the accuracy and feasibility of each diagnostic method. The total time between diagnostic tests and surgery is limited to within 12 months, and written informed consent is required.
CONDITIONS
Official Title
Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD Patients?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 65 18 years
- Obtaining written informed consent
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
G
Gabriele Egidy Assenza, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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