Elective Surgical ProcedureNCT06409234
Perioperative Management & Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients
An observational study of Elective Surgical Procedure, run by European Society of Anaesthesiology at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgical Procedure
- What is being tested?
- Transthoracic Echocardiography Recieved
- How many people
- 8,250 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jun 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: EuPreCHO: European Study on Perioperative Management and 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.
Read the 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
- Conditions
- Elective Surgical Procedure
- Being tested
- Transthoracic Echocardiography Recieved
- Keywords
- transthoracic echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Echocardiography RecievedOther
Transthoracic Echocardiography Recieved
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transthoracic Echocardiography Recieved |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start30 Jun 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgical ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanna Lurati Buse, Prof, Principal investigator, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409234
- Sponsor's protocol ID
- EuPreCHO
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EuPreCHO: European Study on Perioperative Management and Outcome Following Preoperative Transthoracic Echocardiography in Noncardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06409234
- Acronym / sponsor ID
- EuPreCHO
- Conditions
- Elective Surgical Procedure
- Keywords
- transthoracic echocardiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 8,250 participants (estimated)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Other: Transthoracic Echocardiography Recieved5500 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic Echocardiography RecievedTransthoracic Echocardiography Recieved | Other | Exposed group |
Primary outcome
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.
1 secondary outcome
Disability-free survival at 30 days
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanna Lurati Buse, Prof principal investigator
Heinrich-Heine University, Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Surgical Procedure, run by European Society of Anaesthesiology at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saman Sepehr (3222273999, saman.sepehr@esaic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathology (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.