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NCT Number: NCT07496424

Manual- VS Auto-Strain

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Vienna - Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Bruno Mora, Dr, MD, PhD

CONTACT

[email protected]

+4314040041090

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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)

    Time frame: 1 day

Study contacts

Contact information is provided by the study sponsor or research team.

Bruno Mora, Dr, MD, PhD

CONTACT

[email protected]

+4314040041090

Sponsors and collaborators

Lead sponsor

Bruno Mora

Other

Registry information

Official study title

Automated Measurements of Left Ventricular Longitudinal Strain: Are the Results Comparable to Manual Measurements During Cardiac Surgery?

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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