Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification

Recruiting

• Conditions: Tricuspid Regurgitation Congenital

• Registration Number: NCT05748041
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief Summary

The aims of this study are:

1. to explore a novel 2D-Cardiovascular magnetic resonance (CMR) indirect method for tricuspid regurgitation (TR) quantification (ATRIAL method) relying on right atrium variables, and assess its agreement with the traditional indirect method (involving right ventricle variables) and the direct method (based on through-plane phase contrast (PC) sequences on the tricuspid valve);

2. to assess the agreement of TR volume (RVol) and regurgitant fraction quantification from 2D-CMR methods with transthoracic echocardiography and 4DF-CMR methods;

3. to assess the diagnostic performance of 2D-CMR in classifying TR, in terms of RVol and regurgitant fraction, with respect to echocardiographic transthoracic echocardiography grades.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-16
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2D-CMR (different methods)	3 years

Secondary Outcome Measures

Name	Time	Method
RVol and RF	3 years

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milano, Italy