Perioperative Myocardial InjuryAIMYNCT07179029
Anesthesia Induced Myocardial Injury in Non-cardiac Surgery (AIMY)
An observational study of Perioperative Myocardial Injury, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Perioperative Myocardial Injury
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2025to May 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing non- cardiac surgery followed by postoperative blood work
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sibel Sari-Yavuz, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Clinic of Tuebingen
Tübingen
Michael Koeppen, MD, +497071-29 86935, michael.koeppen@med.uni-tuebingen.de
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Cardiac Surgery | Non-Cardiac Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin
Development of Troponin after non-cardiac surgery
Measured: 1-5 days
incidence of PMI
incidence of PMI after non-cardiac surgery
Measured: 1-5 days
Secondary outcomes (1)
Mortality
Mortality after non-cardiac surgery
Measured: 1-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 May 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Myocardial InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Koeppen, MD, Principal investigator, University Clinic of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07179029
- Sponsor's protocol ID
- AIMY
- Acronym
- AIMY
- Status last verified
- May 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Induced Myocardial Injury in Non-cardiac Surgery (AIMY)
- ClinicalTrials.gov ID
- NCT07179029
- Acronym / sponsor ID
- AIMY / AIMY
- Conditions
- Perioperative Myocardial Injury
- Keywords
- troponin, Perioperative myocardial injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 17 Sep 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Cardiac Surgery | – | –Non-Cardiac Surgery |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing non- cardiac surgery followed by postoperative blood work
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- o Patients unable to give consent: intubated and sedated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Troponin
Time frame: 1-5 days
Development of Troponin after non-cardiac surgery
incidence of PMI
Time frame: 1-5 days
incidence of PMI after non-cardiac surgery
1 secondary outcome
Mortality
Time frame: 1-30 days
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 17 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Sibel Sari-Yavuz, MD contact
Michael Koeppen, MD principal investigator
University Clinic of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Myocardial Injury, run by University Hospital Tuebingen at 1 site in Germany.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Contact Michael Koeppen, MD (+497071-29 86935, michael.koeppen@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin (time frame: 1-5 days). The study lists 2 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 17 Sep 2025.