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

NCT06775639 | Recruiting

• 1 other identifier: SPARE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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)?

Conditions

Adult Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

• Non-significant and significant coronary lesions

  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%.

  Immediately after the procedure

• Coronary tree partially or completely unassessable for artifacts or extensive calcifications that prevent proper evaluation

  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.

  immediately after the procedure

Secondary Outcomes (3)

• Side effects/complications from administration of iodinated contrast medium for the performance of Coronary Computer Tomography (CCT) or Invasive CoronaryAngiography (ICA)

  Within 48 hours of the investigation.

• Identification of abnormal origin from the aortic wall of any of the three major coronary arteries (right coronary artery, anterior interventricular branch, branch circumflex); identification of a different than normal course of any of the three main

  At the end of CCT and ICA

• Waiting time for the execution of the of the investigation defined as: time that elapses between the decision to perform CCT and the preoperative ICA

  during the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include ACHD patients referred to the Pediatric Cardiology and Cardiac Surgery of the Cardiology Operating Unit of the IRCCS AOU of Bologna, candidates for surgery cardiac surgery with clinical indication to undergo preoperative ICA and CCT. The SPARE study will include only patients with independent clinical indication to CCT.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gabriele Egidy Assenza, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriele Egidy Assenza, MD

CONTACT

+39 051 2149072; gabriele.egidyassenza@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 15, 2025
• Study Start: January 8, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-10

Locations

IT (1)