Validation of a new method to assess heart tissue using CT scans
Validation of Quantitative Myocardial Tissue Characterization Through Contrast-enhanced Non-gated CT Versus CMR: The VALETUDO-CT Study
NA · IRCCS Policlinico S. Donato · NCT04880317
This study is testing a new CT scan method to see how well it can measure heart tissue changes in patients, especially those who have had COVID-19.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato (other) |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT04880317 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a non-gated computed tomography myocardial relative enhancement (CT-MRE) technique for estimating myocardial extracellular volume (ECV) by comparing it to cardiac magnetic resonance (CMR) results. Patients scheduled for contrast-enhanced cardiac CT will be invited to participate and undergo additional imaging and blood tests. The study also seeks to explore myocardial alterations in patients previously infected with COVID-19. Participants will be monitored for various biomarkers related to myocardial fibrosis and ECV.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who are scheduled for contrast-enhanced cardiac CT.
Not a fit: Patients with contraindications to CMR, severe obesity, or those who cannot undergo the required imaging procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a non-invasive way to assess heart tissue health, improving diagnosis and management of cardiac diseases.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using imaging techniques for cardiac assessment, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred for contrast-enhanced cardiac CT * Age 18 to 80 years Exclusion Criteria: * Absolute contraindications to CMR * Implantable cardioverter defibrillators and ferromagnetic thoracic devices which may cause artifacts at magnetic resonance imaging * Previous allergic reactions to gadolinium-based contrast agents * Pregnancy * Severe obesity * Severe claustrophobia * Too low image quality to perform post-processing analyses
Where this trial is running
San Donato Milanese, Milano
- IRCCS Policlinico San Donato — San Donato Milanese, Milano, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesco Sardanelli, MD
- Email: francesco.sardanelli@unimi.it
- Phone: 0252774468
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.
Conditions: Cardiac Disease, Covid19, Cardiotoxicity, Extracellular Space Alteration, Tomography X-Ray Computed, Magnetic Resonance Imaging, Extracellular Space