Comparing two methods for diagnosing coronary disease in patients with congenital heart disease before surgery
Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD (Adult Congenital Heart Disease) Patients? The SPARE Observational Study
This study is testing whether a non-invasive heart scan can effectively diagnose coronary artery disease in adults with congenital heart disease before surgery, compared to a more invasive procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06775639 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of Invasive Coronary Angiography (ICA) and Coronary Computer Tomography (CCT) in diagnosing significant coronary artery disease in adult patients with congenital heart disease (ACHD) who are candidates for cardiac surgery. The study will assess whether CCT alone is sufficient to identify coronary lesions, potentially reducing the need for ICA. It will also evaluate the occurrence of complications from both procedures and compare their availability in clinical practice. The primary outcomes include the identification of significant and non-significant coronary lesions.
Who should consider this trial
Good fit: Ideal candidates are adults with congenital heart disease who require cardiac surgery and have undergone both ICA and CCT within the last 12 months.
Not a fit: Patients who cannot undergo ICA due to anatomical difficulties or have severe renal failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could reduce the need for invasive procedures in ACHD patients, minimizing risks and improving preoperative care.
How similar studies have performed: While the comparison of ICA and CCT has been explored in other contexts, this specific focus on ACHD patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Gabriele Egidy Assenza, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Gabriele Egidy Assenza, MD
- Email: gabriele.egidyassenza@aosp.bo.it
- Phone: +39 051 2149072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.