Test-retest Reproducibility of Right Heart Parameters of Chamber Size and Function

NCT06193655 | Unknown

• 1 other identifier: 09C219
• Study Type: observational
• Target: 215
• Locations: 0 countries
• Sites: N/A

Brief Summary

The reliability of advanced echocardiographic and cardiac magnetic resonance (CMR) parameters at repeated measurements is not fully clarified. Test-retest reliability of measurements is crucial for follow-up studies and for clinical monitoring of patients to detect a significant change in ventricular performance, as well as to assess the outcome of various therapies on the size and function of cardiac structures. For echocardiography, the variability of the measurement is more complex, as it depends both on acquisition and reading variability, but also closer to the real life setting than observer variability. Much more limited data exist on the test-retest reliability of right heart parameters, i.e. right ventricle (RV), right atrial (RA) and tricuspid annulus (TA) parameters than on their observer variability and than of the equivalent left-sided parameters. The primary aim of the study is to compare the test-retest reproducibility and agreement of advanced echocardiographic parameters of RV and RA size and function, and of tricuspid annulus (TA) size against the respective parameters obtained by conventional echocardiography and by CMR (where applicable).

Conditions

Ventricular Dysfunction, Right

Keywords

right ventricle; right atrium; echocardiography; cardiac magnetic resonance; reproducibility

Outcome Measures

Primary Outcomes (4)

• Right ventricular ejection fraction test-retest reproducibility

  Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes apart by echocardiography and CMR

  Through study completion, an average of 6 months

• Right ventricular longitudinal strain test-retest reproducibility

  Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR

  Through study completion, an average of 6 months

• Right atrial volume test-retest reproducibility

  Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR

  Through study completion, an average of 6 months

• Tricuspid annulus size test-retest reproducibility

  Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR

  Through study completion, an average of 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients fulfilling the study enrolment criteria, with clinical indication to perform echocardiography and CMR study, with a relatively fair distribution of RV ejection fraction: normal (25%), mildly reduced (25%), moderately reduced (25%) and severely reduced (25%)

You may qualify if:

• Age over 18 years old
• Informed consent

You may not qualify if:

• Age \<18 years old
• Pregnancy/breast feeding
• Tricuspid valve repair/prosthesis
• Pacemaker or implantable cardiac defibrillator
• Complex congenital diseases (exceptions: bicuspid aortic valve, atrial septal defect, ventricular septal defect, corrected tetralogy of Fallot)
• Poor acoustic window
• Inability to acquire 3D datasets with at least 20 volumes/s
• Very irregular R-R interval
• Claustrophobia
• Acute conditions
• Hemodynamically instable patients
• Patients who do not provide consent for the study protocol

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Centro Cardiologico Monzino: collaborator

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Gianluca Pontone

  Centro Cardiologico Monzino

  STUDY DIRECTOR

Central Study Contacts

Denisa Muraru, Md, PhD

CONTACT

390261911; denisa.muraru@unimib.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01