Using computer models to predict heart blood flow in patients with coronary artery disease
Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography
This study is testing a computer model that helps doctors better understand blood flow in the hearts of patients with coronary artery disease, aiming to reduce unnecessary scans and radiation exposure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Cardiologico Monzino Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT06337461 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the prediction of outcomes in patients with chronic coronary syndrome by utilizing a computational model that simulates myocardial blood flow under stress conditions. It combines coronary computed tomography angiography (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) to provide both anatomical and functional assessments of coronary artery disease. The goal is to reduce the need for additional scanning and minimize radiation exposure while accurately assessing coronary artery stenosis and atherosclerotic plaque burden. The study focuses on symptomatic patients suspected of having coronary artery disease who are referred for non-invasive coronary angiography.
Who should consider this trial
Good fit: Ideal candidates are symptomatic patients with suspected coronary artery disease who are referred for non-emergent coronary angiography.
Not a fit: Patients with low pre-test likelihood of coronary artery disease or those with a history of myocardial infarction or revascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of coronary artery disease assessments and improve patient outcomes by identifying those at risk more effectively.
How similar studies have performed: Other studies utilizing similar computational modeling approaches have shown promise, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Symptomatic patients with suspected CAD referred for nonemergent, clinically indicated non-invasive coronary angiography. Exclusion Criteria: * Low pre-test likelihood of CAD * Prior myocardial infarction * Previous history of revascularization * Acute coronary syndrome * Need for an emergent procedure * Evidence of clinical instability * Contraindication for contrast agent or impaired renal function * Inability to sustain a breath-hold * Pregnancy * Atrial fibrillation or flutter * BMI \> 35kg/m2 * Presence of pm or ICD * Contraindications to the administration of sublingual nitrates, betablockade, and adenosine
Where this trial is running
Milan, Milan
- Centro Cardiologico Monzino — Milan, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Gianluca Pontone, MD
- Email: gianluca.pontone@cardiologicomonzino.it
- Phone: 0258002574
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.