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

NCT07179029 | Recruiting

• 1 other identifier: AIMY
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Keywords

troponin; Perioperative myocardial injury

Outcome Measures

Primary Outcomes (2)

• Troponin

  Development of Troponin after non-cardiac surgery

  1-5 days

• incidence of PMI

  incidence of PMI after non-cardiac surgery

  1-5 days

Secondary Outcomes (1)

• Mortality

  1-30 days

Study Arms (1)

Non-Cardiac Surgery

Non-Cardiac Surgery

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing non- cardiac surgery followed by postoperative blood work

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Clinic of Tuebingen

Tübingen, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Michael Koeppen, MD

  University Clinic of Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Koeppen, MD

CONTACT

+497071-29 86935; michael.koeppen@med.uni-tuebingen.de

Sibel Sari-Yavuz, MD

CONTACT

sibel.sari@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)