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

Elective Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409234
• Other study ID #: EuPreCHO
• Status: Not yet recruiting
• Start date: June 30, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: European Society of Anaesthesiology
• Contact: Saman Sepehr
• Phone: 3222273999
• Email: saman.sepehr[@]esaic.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8250
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Elective Surgical Procedure

Intervention

Other:
• Transthoracic Echocardiography Recieved
Transthoracic Echocardiography Recieved

Locations

Country	Name	City	State
Germany	University Hospital Düsseldorf	Düsseldorf

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Anaesthesiology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disability-free survival at 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	30 days