Clinical trial NCT06409234: Perioperative Management & Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients
Official title: EuPreCHO: European Study on Perioperative Management and Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Elective Surgical Procedure
Keywords: transthoracic echocardiography
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 8250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Major Pathology
timeFrame: 30 days
Secondary outcomes:
measure: Disability-free survival at 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Giovanna Lurati Buse, Prof
role: PRINCIPAL_INVESTIGATOR
References: