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

NCT06409234 | Not Yet Recruiting

• 1 other identifier: EuPreCHO
• Study Type: observational
• Target: 8,250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Elective Surgical Procedure

Keywords

transthoracic echocardiography

Outcome Measures

Primary Outcomes (1)

• Major Pathology

  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.

  30 days

Secondary Outcomes (1)

• Disability-free survival at 30 days

  30 days

Study Arms (1)

Exposed group

5500 exposed group will be patients in whom Transthoracic Echocardiography was performed within 3 months before surgery. Controls will be patients in whom Transthoracic Echocardiography was NOT performed.

Other: Transthoracic Echocardiography Recieved

Interventions

Transthoracic Echocardiography Recieved OTHER

Transthoracic Echocardiography Recieved

Exposed group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

EuPreCHO is a prospective, international, case control study. RQ3 will be assessed in a cohort consisting of the cases only. Any hospital in Europe (as defined by the World Health Organisation) is welcome to participate as a study centre. Study centre registration occurs online via the dedicated Call for Centres form on the ESAIC website. Centres will be asked to enroll a minimum of 50 cases and 25 controls within the 12-month period planned for EuPreCHO enrollment. Within the enrollment period, the start of recruitment for individual centres is at the discretion of the local PI, provided that there is a prior IRB approval. Recruitment across all centres will continue until enrollment of the planned sample size.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Study Sites (1)

University Hospital Düsseldorf

Düsseldorf, 40225, Germany

Location

Study Officials

• Giovanna Lurati Buse, Prof

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saman Sepehr

CONTACT

3222273999; saman.sepehr@esaic.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: May 10, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)