New method to classify tricuspid regurgitation using heart imaging
Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification
This study is testing a new heart imaging method to see if it can better classify tricuspid regurgitation in patients compared to traditional techniques.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT05748041 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore a novel 2D-Cardiovascular Magnetic Resonance (CMR) method for quantifying tricuspid regurgitation (TR) by analyzing right atrium variables. It will compare this new ATRIAL method with traditional and direct methods of TR quantification, assessing its agreement with transthoracic echocardiography and 4D-CMR methods. The study will also evaluate the diagnostic performance of 2D-CMR in classifying TR based on regurgitant volume and fraction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with at least mild tricuspid regurgitation who are scheduled for a CMR examination.
Not a fit: Patients with previous interventions on the tricuspid valve, those with specific heart conditions like Ebstein's disease, or those with safety concerns related to CMR will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing and classifying tricuspid regurgitation, leading to better patient management.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving cardiac imaging techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients aged ≥ 18 years with the diagnosis of al least mild-degree tricuspid regurgitation, who: * patients that are scheduled for a Cardiovascular Magnetic Resonance examination in our Institution Exclusion Criteria: * Patients with previous surgical or transcatheter interventions on the tricuspid valve * Patients with Ebstein's disease * Subjects with pace-maker or intracardiac defibrillator * Subjects with intrabody ferromagnetic material precluding patient's safety * Patients with claustrophobia or breath-holding precluding an adequate CMR images quality * Pregnant women
Where this trial is running
San Donato Milanese, Milano
- IRCCS Policlinico San Donato — San Donato Milanese, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Giulia Pasqualin, MD
- Email: giulia.pasqualin@grupposandonato.it
- Phone: +390252774502
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.