Implementation of a Clinical Screening and Response System for Cardiac Complications After Noncardiac Surgery

Myocardial Infarction Clinical Trial

— ImplementPMI  

Official title:

Implementation of a Clinical Screening and Response System for the Early Detection of Cardiac Complications After Noncardiac Surgery: Feasibility and Medicoeconomic Impact

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859620
• Other study ID #: 2020-02899
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Christian Puelacher, MD-PhD
• Phone: +41 76 403 44 50
• Email: christian.puelacher[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Injury
• Perioperative Complication

Intervention

Other:
• Patient assessment and follow-up
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.

Locations

Country	Name	City	State
Austria	University Hospital Innsbruck	Innsbruck	Tyrol
Switzerland	University Hospital Geneva	Geneva	GE
Switzerland	Cantonal Hospital Lucerne	Lucerne	LU
Switzerland	Canton Hospital Olten	Olten	SO
Switzerland	Bürgerspital Solothurn	Solothurn

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Bürgerspital Solothurn, Kantonsspital Olten, Luzerner Kantonsspital, Medical University Innsbruck, University Hospital, Geneva

Countries where clinical trial is conducted

Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	during the hospital stay (up to postoperative day 2)
Primary	Incidence of PMI	Percentage of patients experiencing PMI following noncardiac surgery	after the surgery until postoperative day 2
Primary	Cardiology consultation (Fidelity)	Percentage of patients with detected PMI by PMI-screening on screening days, seen vs. not seen by a cardiologist	during hospital stay (up to postoperative day 5)
Primary	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	during hospital stay (up to postoperative day 5)
Primary	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	following the post-implementation period (6 months after implementation)
Secondary	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	Within 3 - 30 days following surgery
Secondary	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	Within 3 - 30 days following surgery
Secondary	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	1 year
Secondary	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)	30 days
Secondary	Major bleeding	Bleeding Academic Research Consortium Typ 3-5	Postoperative day 1 - 1 year (blinding of first 24h following surgery)