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NCT Number: NCT06775639

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

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)?

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Key information

Conditions

Adult Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Gabriele Egidy Assenza, MD

CONTACT

[email protected]

+390512149072

Gabriele Egidy Assenza, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Non-significant and significant coronary lesions

    Time frame: Immediately after the procedure

    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%.

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

    Time frame: immediately after the procedure

    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.

Secondary outcomes

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

    Time frame: Within 48 hours of the investigation.

    Creatininemia elevation of 0.3 mg/dl within 48 hours after surgery, or more than 150% of the initial value or a reduction of diuresis below 0.5 ml/Kg for more than 6 hours. Incidence of cardiac death, heart attack myocardial infarction, stroke, vascular complications and nonvascular at the site of access ie. finding of vascular aneurysm or pseudoaneurysm or obstruction of the artery used for ICA, major bleeding defined as of grade 3 or higher according to the BARC classification.

  2. 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

    Time frame: At the end of CCT and ICA

    Abnormal origin: finding of abnormal position compared to the normal anatomical position of the ostium of at least one of the coronary arteries (right coronary artery, common trunk or anterior interventricular branch and branch circumflex). Abnormal course: different than normal course of one of the three major arteries coronary arteries. Dangerous course: course through the large vessels (aorta and pulmonary artery or other paracardiac) of one of the three major coronary arteries.

  3. 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

    Time frame: during the procedure

    Interval of time between the decision of the execution of the investigation and the date on which the investigation is conducted

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriele Egidy Assenza, MD

CONTACT

[email protected]

+39 051 2149072

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD (Adult Congenital Heart Disease) Patients? The SPARE Observational Study

Acronym: SPARE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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