Myocardial InjuryImplementPMINCT05859620
Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery
An observational study of Myocardial Injury and Myocardial Infarction, run by University Hospital, Basel, Switzerland at 5 sites in 2 countries.
Trial summary
The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Myocardial Injury, Myocardial Infarction, Perioperative Complication
- What is being tested?
- Patient assessment and follow-up
- How many people
- 900 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jul 2021to Jul 2027
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 40-85 years at increased cardiovascular risk undergoing inpatient, noncardiac, elective or emergent surgery with a planned postoperative stay of ≥2 nights
Who may be able to join
- Consecutive patients fulfilling the institutional criteria for inclusion into the routine PMI-screening
- aged 40-85 years
- at increased cardiovascular risk
- undergoing inpatient, noncardiac, elective or emergent surgery
- postoperative stay of ≥2 nights at the participating institution
- orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, and visceral surgery.
Who cannot join
- patients with cardiac surgery or interventions in the last 14 days
- chronic renal failure under dialysis, renal transplant surgery
- moderate-to-severe dementia
- previous inclusion within 5 days
- documented refusal to use of their data for research purposes or refusal of further use during follow-up
- Patients declining consent for follow-up will be excluded from follow-up analyses.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Switzerland4 sites
University Hospital Geneva
Geneva, Canton of Geneva, 1205
Cantonal Hospital Lucerne
Lucerne, Canton of Lucerne, 6000
Canton Hospital Olten
Olten, Canton of Solothurn, 4600
Bürgerspital Solothurn
Solothurn, 4500
About this study
Official title: Implementation of a Clinical Screening and Response System for the Early Detection of Cardiac Complications After Noncardiac Surgery: Feasibility and Medicoeconomic Impact
The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients.
Specifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.
Read the detailed description
Background: Perioperative myocardial infarction/injury (PMI) is increasingly recognised as frequent, but often undiagnosed and untreated contributor to mortality following noncardiac surgery. Due to differences in pathophysiology and perioperative anaesthesia and analgesia, most PMI do not cause typical ischemic symptoms and are therefore missed in routine clinical practice. Active surveillance using cardiac troponin (cTn) is now guideline-recommended for the early detection of PMI to possibly improve outcome1. Given substantial concerns regarding the feasibility and health economic impact of implementing such a strategy, it is not yet widely applied.
Aim: to show feasibility of implementation as well as health economic impact of an active surveillance for the early detection of PMI in high-risk patients.
Methodology: in this observational before-after study the investigators will enrol patients at high cardiovascular risk undergoing noncardiac surgery before and after implementation of a PMI screening. Patients in the pre-implementation phase will receive standard of care, while in the post-implementation phase patients receive a PMI-screening, consisting of a preoperative and two postoperative measurements of high-sensitivity cTn (hs-cTn) and a cardiology consultation will be done in case of detection of a PMI. Patient data, resource utilisation, and PMI-aetiology will be collected. Interviews with key stakeholders will identify barriers to implementation. One-year follow-up will be conducted to evaluate occurrence of death, MACE, and safety endpoints.
Potential significance: This study will generate important insights regarding the feasibility, safety and the health economic impact of implementing an active surveillance for the early detection of PMI.
- Being tested
- Patient assessment and follow-up
- Keywords
- Myocardial injury, Myocardial infarction, Perioperative care, Noncardiac surgery, Screening
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient assessment and follow-upOther
There is no study-specific intervention. The investigators will record data generated by clinical activity before, during and after implementation of the PMI-screening. Follow-up data and the final PMI event adjudication will be the only data generated specifically for this study.
| Study group | Role | What they receive |
|---|---|---|
| Before implementation | Patients included before implementation of the PMI-screening Receives: Other: Patient assessment and follow-up | |
| After implementation | Patients included after implementation of the PMI-screening Receives: Other: Patient assessment and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach)
Percentage of patients eligible for PMI-screening according to inclusion criteria, but not screened during the implementation phase (defined as no or only one measurement of hs-cTn done during screening days)
Measured: during the hospital stay (up to postoperative day 2)
Incidence of PMI
Percentage of patients experiencing PMI following noncardiac surgery
Measured: after the surgery until postoperative day 2
Cardiology consultation (Fidelity)
Percentage of patients with detected PMI by PMI-screening on screening days, seen vs. not seen by a cardiologist
Measured: during hospital stay (up to postoperative day 5)
Diagnostic challenge
Number of cases with mismatch of initial classification of PMI aetiology (and management pathway) at time of consultation versus final adjudication. In case of two differential diagnoses stated on the cardiology consultation, mismatch is seen when none of the diagnoses correspond to the final adjudication. If three or more differential diagnoses are stated, mismatch is seen in any case even if the final adjudication diagnosis is stated
Measured: during hospital stay (up to postoperative day 5)
Barriers to implementation
Barriers to implementation will be assessed by a semi-quantitive questionnaire complemented by qualitative focus group including the local investigators and representatives of cardiology and anaesthesiology
Measured: following the post-implementation period (6 months after implementation)
Secondary outcomes (5)
Medicoeconomic impact
Cost of postoperative blood draws on day 1 and 2, length of hospital stay, days on intensive care unit, consultations within day 1-3, ECG within day 1-3, cardiac stress testing within 30 days, and cardiac catheterisation within 30 days, denoted in Swiss Francs
Measured: Within 3 - 30 days following surgery
Resource Usage
Number of postoperative blood draws on day 1 and 2, length of hospital stay, days on intensive care unit, consultations within day 1-3, ECG within day 1-3, cardiac stress testing within 30 days, and cardiac catheterisation within 30 days
Measured: Within 3 - 30 days following surgery
Major adverse cardiac events (MACE)
Occurrence and timing of a composite of major adverse cardiac events (MACE) within twelve months, consisting of: All-cause death, acute myocardial infarction Type 1, survived sudden cardiac death, and Acute heart failure
Measured: 1 year
Complications of cardiology diagnostics
Number of inappropriate interventions or complications of cardiology diagnostics and interventions, consisting of: Overtreatment (Coronary angiographies showing normal coronaries), complications of cardiac interventions (myocardial infarction, stroke, death)
Measured: 30 days
Major bleeding
Bleeding Academic Research Consortium Typ 3-5
Measured: Postoperative day 1 - 1 year (blinding of first 24h following surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jul 2021
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Luzerner Kantonsspital, Kantonsspital Olten, Medical University Innsbruck, University Hospital, Geneva, Bürgerspital Solothurn
- Responsible party
- Sponsor
- Investigators
- Christian Puelacher, MD-PhD, Principal investigator, University Hospital, Basel, SwitzerlandChristian Müller, Prof., Study director, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859620
- Sponsor's protocol ID
- 2020-02899
- Acronym
- ImplementPMI
- Status last verified
- May 2026
- First submitted
- 6 Feb 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing with other research groups will be the responsibility of the PI.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Clinical Screening and Response System for the Early Detection of Cardiac Complications After Noncardiac Surgery: Feasibility and Medicoeconomic Impact
- ClinicalTrials.gov ID
- NCT05859620
- Acronym / sponsor ID
- ImplementPMI / 2020-02899
- Keywords
- Myocardial injury, Myocardial infarction, Perioperative care, Noncardiac surgery, Screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Luzerner Kantonsspital, Kantonsspital Olten, Medical University Innsbruck, University Hospital, Geneva, Bürgerspital Solothurn
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 16 May 2023 (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.
The investigators aim to show the feasibility and medicoeconomic impact of implementing a clinical screening and response system for the early detection of perioperative cardiac complications in high-risk patients.
Specifically, the investigators aim to: 1) evaluate the feasibility of implementation of a PMI-screening; 2) evaluate the medicoeconomic impact of implementing a PMI-screening; 3) identify barriers to implementation; 4) generate data for a future randomized controlled trial on outcomes by exploring opportunities to improve care following PMI, the occurrence and timing of major adverse cardiac events (MACE), and the treatment effect associated with PMI-screening.
Detailed description
Background: Perioperative myocardial infarction/injury (PMI) is increasingly recognised as frequent, but often undiagnosed and untreated contributor to mortality following noncardiac surgery. Due to differences in pathophysiology and perioperative anaesthesia and analgesia, most PMI do not cause typical ischemic symptoms and are therefore missed in routine clinical practice. Active surveillance using cardiac troponin (cTn) is now guideline-recommended for the early detection of PMI to possibly improve outcome1. Given substantial concerns regarding the feasibility and health economic impact of implementing such a strategy, it is not yet widely applied.
Aim: to show feasibility of implementation as well as health economic impact of an active surveillance for the early detection of PMI in high-risk patients.
Methodology: in this observational before-after study the investigators will enrol patients at high cardiovascular risk undergoing noncardiac surgery before and after implementation of a PMI screening. Patients in the pre-implementation phase will receive standard of care, while in the post-implementation phase patients receive a PMI-screening, consisting of a preoperative and two postoperative measurements of high-sensitivity cTn (hs-cTn) and a cardiology consultation will be done in case of detection of a PMI. Patient data, resource utilisation, and PMI-aetiology will be collected. Interviews with key stakeholders will identify barriers to implementation. One-year follow-up will be conducted to evaluate occurrence of death, MACE, and safety endpoints.
Potential significance: This study will generate important insights regarding the feasibility, safety and the health economic impact of implementing an active surveillance for the early detection of PMI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before implementation | – | Other: Patient assessment and follow-upPatients included before implementation of the PMI-screening |
| After implementation | – | Other: Patient assessment and follow-upPatients included after implementation of the PMI-screening |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 40-85 years at increased cardiovascular risk undergoing inpatient, noncardiac, elective or emergent surgery with a planned postoperative stay of ≥2 nights
Key inclusion criteria (6 listed)
- Consecutive patients fulfilling the institutional criteria for inclusion into the routine PMI-screening
- aged 40-85 years
- at increased cardiovascular risk
- undergoing inpatient, noncardiac, elective or emergent surgery
- postoperative stay of ≥2 nights at the participating institution
Key exclusion criteria (6 listed)
- patients with cardiac surgery or interventions in the last 14 days
- chronic renal failure under dialysis, renal transplant surgery
- moderate-to-severe dementia
- previous inclusion within 5 days
- documented refusal to use of their data for research purposes or refusal of further use during follow-up
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 |
|---|---|---|
| Patient assessment and follow-upThere is no study-specific intervention. The investigators will record data generated by clinical activity before, during and after implementation of the PMI-screening. Follow-up data and the final PMI event adjudication will be the only data generated specifically for this study. | Other | After implementation, Before implementation |
Primary outcome
Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach)
Time frame: during the hospital stay (up to postoperative day 2)
Percentage of patients eligible for PMI-screening according to inclusion criteria, but not screened during the implementation phase (defined as no or only one measurement of hs-cTn done during screening days)
Incidence of PMI
Time frame: after the surgery until postoperative day 2
Percentage of patients experiencing PMI following noncardiac surgery
Cardiology consultation (Fidelity)
Time frame: during hospital stay (up to postoperative day 5)
Percentage of patients with detected PMI by PMI-screening on screening days, seen vs. not seen by a cardiologist
Diagnostic challenge
Time frame: during hospital stay (up to postoperative day 5)
Number of cases with mismatch of initial classification of PMI aetiology (and management pathway) at time of consultation versus final adjudication. In case of two differential diagnoses stated on the cardiology consultation, mismatch is seen when none of the diagnoses correspond to the final adjudication. If three or more differential diagnoses are stated, mismatch is seen in any case even if the final adjudication diagnosis is stated
Barriers to implementation
Time frame: following the post-implementation period (6 months after implementation)
Barriers to implementation will be assessed by a semi-quantitive questionnaire complemented by qualitative focus group including the local investigators and representatives of cardiology and anaesthesiology
5 secondary outcomes
Medicoeconomic impact
Time frame: Within 3 - 30 days following surgery
Resource Usage
Time frame: Within 3 - 30 days following surgery
Major adverse cardiac events (MACE)
Time frame: 1 year
Complications of cardiology diagnostics
Time frame: 30 days
Major bleeding
Time frame: Postoperative day 1 - 1 year (blinding of first 24h following surgery)
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 5 May 2026.
- Individual participant dataSharing planned: Undecided. Data sharing with other research groups will be the responsibility of the PI.
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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. This study is not recruiting at the moment.
Christian Puelacher, MD-PhD principal investigator
University Hospital, Basel, Switzerland
Christian Müller, Prof. study director
University Hospital, Basel, Switzerland
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Injury and Myocardial Infarction, run by University Hospital, Basel, Switzerland at 5 sites in 2 countries.
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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland, Austria. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Myocardial Infarction/Injury (PMI)-Screening (Reach) (time frame: during the hospital stay (up to postoperative day 2)). The study lists 5 primary outcomes in all. 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 5 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.