Adult Congenital Heart DiseaseSPARENCT06775639
Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD Patients?
An observational study of Adult Congenital Heart Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Congenital Heart Disease
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2025to 1 May 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Gabriele Egidy Assenza, MD, +390512149072, gabriele.egidyassenza@aosp.bo.it
Gabriele Egidy Assenza, MD
About this study
Official title: Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD (Adult Congenital Heart Disease) Patients? The SPARE Observational Study
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)?
Read the 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
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
Interval of time between the decision of the execution of the investigation and the date on which the investigation is conducted
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start8 Jan 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriele Egidy Assenza, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775639
- Sponsor's protocol ID
- SPARE
- Acronym
- SPARE
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Should we Avoid Performing Invasive Coronary Angiography Before Cardiac Surgery in ACHD (Adult Congenital Heart Disease) Patients? The SPARE Observational Study
- ClinicalTrials.gov ID
- NCT06775639
- Acronym / sponsor ID
- SPARE / SPARE
- Conditions
- Adult Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 8 Jan 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
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.
3 secondary outcomes
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.
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriele Egidy Assenza, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Congenital Heart Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Egidy Assenza, MD (+39 051 2149072, gabriele.egidyassenza@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-significant and significant coronary lesions (time frame: Immediately after the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.