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Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification

Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05748041
Acronym
TRAC
Enrollment
76
Registered
2023-02-28
Start date
2021-02-16
Completion date
2024-12-31
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Regurgitation Congenital

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.

Interventions

None listed

Sponsors

IRCCS Policlinico S. Donato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
2D-CMR (different methods)3 years

Secondary

MeasureTime frame
RVol and RF3 years

Other

MeasureTime frame
TTE, performed within 30 days from the CMR examination3 years

Countries

Italy

Contacts

Primary ContactGiulia Pasqualin, MD
giulia.pasqualin@grupposandonato.it+390252774502

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026