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NCT Number: NCT06409234

Perioperative Management & Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients

In August 2022 the European Society of Cardiology published updated guidelines including recommendations on preoperative transthoracic echocardiography. The update resulted in broadened criteria for preoperative transthoracic echocardiography. The impact of preoperative transthoracic echocardiography on outcome is controversial and the evidence was mostly derived from administrative databases. Also there is also a knowledge gap in terms of what changes in perioperative managements are derived from transthoracic echocardiography information in current daily practice in Europe and what their impact on outcome may be. Further, a secondary analysis in a large international cohort suggests that the criteria endorsed by the guidelines to define the class of recommendation of transthoracic echocardiography may not be efficient.

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Key information

Conditions

Elective Surgical Procedure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Düsseldorf

Düsseldorf, 40225, Germany

About this study

The target population consists of patients at elevated cardiovascular risk undergoing elective, intermediate or high-risk noncardiac surgery. The planned sample size is 5500 exposed and 2750 non-exposed

Who can participate

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

Inclusion criteria

  • aged ≥65 years OR
  • above 18 years and presenting ≥2 cardiovascular risk factors (hypertension, smoking, dyslipidaemia, diabetes, family history of CVD) OR
  • above 18 years with known cardiovascular disease

Exclusion criteria

  • under 18 years of age
  • day surgery
  • urgent/emergency procedures
  • current ICU patient (i.e. in ICU on day-1 or the day of the index surgery (day 0)),
  • cardiac surgery within the last month prior according to the index noncardiac procedure (of note this does not include cardiological interventions like TAVI or valvuloplasty),
  • unwilling or unable to provide informed consent,
  • unable to complete the WHODAS questionnaire (literacy or language barrier)
  • Previous enrollment in EuPreCHO (in case of repeated surgery)

Treatment and study plan

Transthoracic Echocardiography Recieved

Other

Transthoracic Echocardiography Recieved

Primary outcomes

  1. Major Pathology

    Time frame: 30 days

    Decreased contractility (LVEF ≤40% by Simpson's method or eyeballing) or based on corresponding qualitative statement in TTE report. Significant LV diastoic: E/A <0.8 + E>50cm/sec OR E/A >0.8 to <2 + at least ≥ 2 additional criteria ( Average E/e' ratio >14, peak TR velocity >2,8 m/sec, LA volume index >34 mL/m2.

Secondary outcomes

  1. Disability-free survival at 30 days

    Time frame: 30 days

    WHODAS scale-none=0 to extreme=4, for a total maximal score of 48 and transformed into the percentage of maximal disability score

Study contacts

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

Saman Sepehr

CONTACT

[email protected]

3222273999

Sponsors and collaborators

Lead sponsor

European Society of Anaesthesiology

Other

Registry information

Official study title

EuPreCHO: European Study on Perioperative Management and Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 10, 2024
Registry last updated
May 10, 2024

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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