Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748041
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-02-01
Brief Title:
Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification
Sponsor:
IRCCS Policlinico S Donato
Organization:
IRCCS Policlinico S Donato
Study Overview
Official Title:
Multiparametric Approach to Identify a CMR-based Tricuspid Regurgitation Classification
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRAC
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None