NCT07561151

Brief Summary

Left atrial (LA) size and function are powerful prognostic markers in a variety of clinical conditions. Cardiac magnetic resonance (CMR) is considered the gold-standard to assess the volumes of heart chambers by contouring cavity borders at end-diastole and end-systole from a short-axis cine stack. This method is routinely used to measure ventricular volumes and ejection fraction, but has never been implemented for LA volume measurements, due to the need of a significant lengthening of both CMR acquisition and post-processing times. Current CMR guidelines do not provide any specific recommendation on LA imaging in daily routine, and LA volume is usually evaluated by using the biplane area-length algorithm in standard cine long-axis images. Yet, the latter methodology implies geometric assumptions about the LA shape that are often not fulfilled in routine patients. Moreover, the standard long-axis views are oriented according to the major axis of the left ventricle (LV), which lies in a plane with a different spatial orientation compared with the LA. As a result, standard long-axis views optimized according to the maximal LV length commonly foreshorten the LA and therefore underestimate its size. Accordingly, a previous echocardiographic study showed that long-axis views focused on the LA were more accurate to derive LA maximal volume vs. standard long-axis views. Differently from echocardiography, CMR allows to orientate images during acquisition process with no dependency from acoustic windows. Capturing the true LA long-axis by focused imaging is therefore more feasible with CMR vs. two-dimensional echocardiography. Compared to current CMR practice, implementation of focused LA long-axis views might result in improved accuracy of LA volumes estimation with no significant delay on acquisition times (Figure). LA dysfunction, as assessed by deformation analysis, is emerging as an early prognostic marker in several cardiac diseases. At present, standard long-axis cine images are used for CMR feature tracking (CMR-FT), which allows the assessment of atrial phasic functions. Of core importance, CMR-FT derived strain parameters \[i.e., LA total strain (εs), conduit strain (εe), and booster strain (εa)\] are sensible to plan orientation and might be affected by foreshortening. Current CMR protocols use long-axis cine images oriented on the LV long axis and may systematically underestimate LA size and function. We hypothesize that LA-focused long-axis cine images at CMR are more accurate in estimating LA volumes and function than current practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

April 16, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

Left atriumCardiac Magnetic Resonance

Outcome Measures

Primary Outcomes (5)

  • Left atrial volume - focused long-axis views

    Left atrial volume obtained by focused long-axis imaging

    Baseline

  • Left atrial volume - standard long axis views

    Left atrial volume obtained by standard long-axis imaging

    Baseline

  • Duration of acquisition of focused long-axis views of left atrium

    Duration of acquisition of focused long-axis views of left atrium in minutes

    Baseline

  • Longitudinal strain - focused long-axis views

    CMR Feature Tracking (CMR-FT) strain obtained by focused long-axis imaging

    Baseline

  • Longitudinal strain - standard long-axis views

    CMR Feature Tracking (CMR-FT) strain obtained by standard long-axis imaging

    Baseline

Study Arms (1)

Clinically indicated CMR

Patients who undergo clinically indicated CMR

Diagnostic Test: CMR scan

Interventions

CMR scanDIAGNOSTIC_TEST

CMR image acquisition and analysis of the left atrium

Clinically indicated CMR

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who undergo clinically indicated CMR

You may qualify if:

  • Older than 18 years
  • Clinically indicated CMR with diagnostic image quality
  • Signed informed consent

You may not qualify if:

  • Unwillingness to participate in the study
  • Congenital heart disease
  • Pregnancy or breast-feeding
  • Any other contraindication to CMR study
  • Heart transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico San Donato, IRCCS

San Donato Milanese, 20100, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

May 1, 2026

Study Start

May 25, 2021

Primary Completion

August 25, 2025

Study Completion

August 25, 2025

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations