NCT07496424

Brief Summary

Myocardial strain analysis provides additional and valuable information about left ventricular function, particularly in the perioperative setting with its dynamic changes in ventricular load conditions. This allows for earlier risk assessment and, if necessary, the initiation of faster and more targeted therapy. Unfortunately, conventional strain analysis using conventional methods currently takes approximately 5 minutes. However, this amount of time is often not available in a dynamically changing intraoperative setting during cardiac surgery. Therefore, the benefits of strain analysis have not yet been routinely utilized during the intraoperative course. However, new software solutions exist that can perform strain analysis fully automatically and reduce the examination time to a few seconds. However, it remains unclear whether these fully automated analyses also function reliably intraoperatively using transesophageal echocardiography (TEE). The aim of this study is to assess the reliability of these new methods.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 22, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 22, 2026

Last Update Submit

March 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation between conventionally measured global longitudinal strain (GLS) and fully automated global longitudinal strain (Auto-GLS)

    1-3 days

Secondary Outcomes (1)

  • Correlation between fully automated global longitudinal strain measured using GE EchoPac (GE-Auto-GLS) and fully automated global longitudinal strain measured using TOMTEC AutoStrain (TOMTEC Auto-GLS)

    1 day

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing cardiac surgery who are monitored with a transesophageal echocardiography probe

You may qualify if:

  • Adult (≥18 years) cardiac surgery patients
  • Sinus rhythm
  • No severe valvular regurgitation
  • Use of General Electric (GE) echocardiography systems (Vivid S60, S70, E95) and corresponding EchoPAC software as well as TOMTEC software.

You may not qualify if:

  • Inadequate image quality
  • Any severe heart valve regurgitation
  • Mechanical circulatory support systems (e.g., LVAD, Impella, ECMO)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Vienna - Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Bruno Mora, Dr, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 22, 2026

First Posted

March 27, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

March 23, 2027

Study Completion (Estimated)

March 23, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations