Anesthesia Induced Myocardial Injury in Non-cardiac Surgery (AIMY)

NCT ID: NCT07179029

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-05-31

Brief Summary

Myocardial injury during non-cardiac surgery (PMI) affects up to 16% of high-risk patients and represents a significant burden on healthcare systems. An acute myocardial infarction is defined by a dynamic increase in cardiac troponin (cTn) above the 99th percentile and is accompanied by clinical signs of myocardial ischemia. Myocardial injury, on the other hand, is characterized by an increase in cardiac troponin, but without meeting the diagnostic criteria for myocardial infarction. In the perioperative interval, however, it is irrelevant whether a myocardial infarction according to the universal definition or merely an increase in troponin is present, as there is no difference in mortality between the two patient groups. The comprehensive study by Botto et al. provides valuable insights into the severity of MINS and found that 8.0% of patients met the diagnostic criteria. An important finding of this study is that the majority of MINS cases (87.1%) occurred within the first two days after surgery, highlighting the immediate risk of the condition (Botto et al., 2014).

We would like to emphasize the necessity of our prospective, multicenter observational study by highlighting anesthesia-dependent variables such as hemodynamics, type of medication, their potential role, and surgical aspects such as duration of surgery, which represent risk factors for MINS. Identifying and understanding modifiable and non-modifiable risk factors is essential for targeted preoperative intervention. Understanding these factors is crucial for subsequent interventional studies and can also provide criteria for increased monitoring of high-risk patients, as suggested in the current guidelines.

Conditions

Perioperative Myocardial Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-Cardiac Surgery

Non-Cardiac Surgery

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Elective or emergency non-cardiac surgery
• Cardiovascular risk: At least two of the following: Age >60 years, hypertension, diabetes mellitus, coronary heart disease, peripheral arterial occlusive disease, cerebrovascular disease, chronic renal insufficiency, chronic heart failure, chronic obstructive pulmonary disease, active smoking
• Age criteria: Adults aged 40-80 years.
• ASA status: ASA classification II-IV.
• Written consent after prior explanation

Exclusion Criteria

• o Patients unable to give consent: intubated and sedated patients

• Types of surgery: cardiac surgery, including coronary artery bypass grafting, heart valve repair or replacement, and heart transplantation; obstetric procedures, including cesarean section; minor surgical procedures that do not require general or regional anesthesia (e.g., minor dermatological or ophthalmological procedures)
• Cardiovascular risk: patients without at least two of the following risk factors: age <40 or >80, no history of hypertension, diabetes, coronary artery disease, peripheral arterial disease, cerebrovascular disease, chronic renal failure, chronic heart failure, chronic obstructive pulmonary disease, and non-smoker status
• Age criteria: Patients under 40 or over 80 years of age
• ASA status: ASA classification of I.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Koeppen, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinic of Tuebingen

Locations

University Clinic of Tuebingen

Tübingen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Koeppen, MD

Role: CONTACT

michael.koeppen@med.uni-tuebingen.de

+497071-29 86935

Sibel Sari-Yavuz, MD

Role: CONTACT

sibel.sari@med.uni-tuebingen.de

Facility Contacts

Michael Koeppen, MD

Role: primary

michael.koeppen@med.uni-tuebingen.de

+497071-29 86935

Other Identifiers

AIMY

Identifier Type: -

Identifier Source: org_study_id