Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification

NCT ID: NCT05748041

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-16

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Tricuspid Regurgitation Congenital

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Policlinico S. Donato

OTHER

Sponsor Role lead

Responsible Party

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Giulia Pasqualin

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Policlinico San Donato

San Donato Milanese, Milano, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giulia Pasqualin, MD

Role: CONTACT

+390252774502

Facility Contacts

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Giulia Pasqualin, MD

Role: primary

+390252774502

Other Identifiers

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TRAC

Identifier Type: -

Identifier Source: org_study_id

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