Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification (TRAC)

October 3, 2023 updated by: Giulia Pasqualin, IRCCS Policlinico S. Donato

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of tricuspid regurgitation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2D-CMR (different methods)
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
RVol and RF
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Time Frame
TTE, performed within 30 days from the CMR examination
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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