Multiparametric Approach to Identify a CMR-based Tricuspi... | NCT05748041

Studies
Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification

NCT05748041

Sponsor

IRCCS Policlinico S. Donato

Status

Unknown status

Last Update Posted

Oct 4, 2023Actual

Enrollment

76Estimated

Phase

Not provided

Conditions

Tricuspid Regurgitation Congenital

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2021Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Feb 1, 2023

First Submission Date that Met QC Criteria

Feb 17, 2023

First Posted Date

Feb 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2023

Last Update Posted Date

Oct 4, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aims of this study are:

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
RVol and RF		3 years

Other Outcomes

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of tricuspid regurgitation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giulia Pasqualin, MD	Contact	+390252774502		giulia.pasqualin@grupposandonato.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Policlinico San Donato	Recruiting	San Donato Milanese	Milano	20097	Italy