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NCT Number: NCT07179029

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

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.

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Key information

Conditions

Perioperative Myocardial Injury

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Troponin

    Time frame: 1-5 days

    Development of Troponin after non-cardiac surgery

  2. incidence of PMI

    Time frame: 1-5 days

    incidence of PMI after non-cardiac surgery

Secondary outcomes

  1. Mortality

    Time frame: 1-30 days

    Mortality after non-cardiac surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Koeppen, MD

CONTACT

[email protected]

+497071-29 86935

Sibel Sari-Yavuz, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: AIMY

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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