Perioperative Myocardial InfarctionPMI-VITALNCT05866874
Monitoring of Vital Signs for Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery
An observational study of Perioperative Myocardial Infarction and Perioperative Myocardial Injury, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The goal of this observational prospective cohort study is to learn about the pathophysiology of perioperative myocardial infarction/injury in high-risk patients undergoing major non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Perioperative Myocardial Infarction, Perioperative Myocardial Injury
- How many people
- 875 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Sep 2022to Dec 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients that underwent a systematic approach to PMI detection at the hospital as clinical routine will be included.
Who may be able to join
- Patient eligible for routine PMI-screening
- Patient requiring hospitalisation with ≥ 2 overnight stays after surgery
- Age ≥ 40 years to ≤ 85 AND history of coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease/stroke, insulin-dependent diabetes mellitus (IDDM), or chronic heart failure (CHF)
- Elective surgery
- Patients undergoing orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, urological or visceral surgery
- Patient consent available
Who cannot join
- Patient's refusal
- Heart surgery, cardiac arrest, acute mycardial infarction (AMI), cardiac valve intervention, or cardiac catheter ablation within 14 days prior to surgery OR involvement of heart surgery at index surgery OR surgery planned on cardiopulmonary bypass
- Patients undergoing plastic/reconstructive, ophthalmologic, dental, hand surgery, or ear-nose-and-throat surgery
- Chronic renal failure on dialysis, unless undergoing renal transplant surgery
- Moderate to severe dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, Canton of Basel-City, 4031
Christian Müller, MD, Prof, +41 61 328 6549, christian.mueller@usb.ch
Christian Puelacher, MD-PhD, +41 61 556 5830, christian.puelacher@usb.ch
About this study
Official title: Continuous Monitoring of Vital Signs for Improved Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery in High Risk Patients: PMI-VITAL
The goal of this observational prospective cohort study is to learn about the pathophysiology of perioperative myocardial infarction/injury in high-risk patients undergoing major non-cardiac surgery.
Participants will:
- Wear wearable device (Basler Band) for up to seven days after the operation or until hospital discharge
- Provide three blood samples. A venous specimen of blood (25 mL) will be collected preoperatively and on postoperative days 1 and 2.
- Be contacted to answer a questionnaire one year after the surgery.
Read the detailed description
Background:
With over 300 million surgical procedures performed annually, surgery and anaesthesia provide major medical value to patients, especially in resource-rich countries like Switzerland with about 900.000 procedures done per year. Demand for surgery is expected to further increase in the coming years due to the aging of the population and the availability of novel less invasive surgical procedures making even elderly patients with extensive comorbidities possibly eligible for surgery.
Perioperative myocardial infarction/injury (PMI) has been identified as a major contributor to perioperative mortality. First studies estimated that PMI is a major contributor to 34-42% of all deaths following noncardiac surgery within 30 days. Recent research by several groups including ours has highlighted that PMI is not a homogenous disease entity, but seems to comprise several underlying pathophysiologies. These include type I myocardial infarction due to atherothrombosis, type II myocardial infarction due to myocardial oxygen supply-demand mismatch, tachyarrhythmias, acute heart failure, and PMI due to primarily extra-cardiac disorders such as severe sepsis, stroke, or pulmonary embolism. Unfortunately, the underlying pathophysiology of PMI remains unknown in many patients. This is among other things due to incomplete recording and documentation of patient vital signs including heart rate, blood pressure, and oxygen saturation e.g. in the postoperative period once patients leave the operating room. Identifying the underlying trigger of PMI is a prerequisite for causal therapy and prevention.
Objectives:
- To continuously document and quantify the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxemia, that are not recorded and documented using the current clinical monitoring standards, but detected using continuous monitoring of vital signs using the wearable device (Basler Band) throughout the whole perioperative period.
- To validate the diagnosis of PMI within a screening program in high-risk patients undergoing major noncardiac surgery with other troponin assays.
- To evaluate the diagnostic and predictive utility of novel biochemical markers.
- To technically validate intraoperative haemodynamic measurements of wearable device by comparing them to routinely obtained intraoperative haemodynamics.
Number of Participants:
We expect PMI to occur in 15-20% of patients. We expect 35% of cases to fall in the adjudication category of "cardiac, unknown" in first adjudication. Continuous vital signs and biomarkers are expected to allow to adjudicate ~33% of PMI from the category "unknown" to any of the other definite categories. Using a Chi-square test for final analysis, we calculate a needed sample size of approximately 125 PMI. With worst-case PMI-incidence of 15%, and a buffer of 5% additional cases to compensate for technical difficulties which are expected to arise with continuous monitoring, we require a total sample size of 875 patients included into the cohort.
Methodology:
After obtaining written informed consent, a venous specimen of blood (25 mL) is collected preoperatively and the patient will receive the wearable device. Further venous blood samples are withdrawn on postoperative days 1 and 2 (each 25 mL). As all patients will be included into the routine troponin screening implemented at the University Hospital Basel, blood draws will be coordinated with routine blood draws as far as possible. The wearable device will be worn until seven days after surgery or until hospital discharge.
Project duration for each patient will be approximately one week plus the answering of a questionnaire one year after the surgery.
Biobank:
One preoperative and two postoperative venous blood samples are collected into plastic tubes containing sodium citrate 1:10 (4.3 mL), heparin (4.7 mL), ethylenediaminetetraacetic acid (EDTA, 7.5 mL) and a clotting activator for serum diagnostics (7.5 mL). The biological material collected will be coded and stored on study site (or in the biobank of the University Hospital Basel) for an indefinite period of time. During this timeframe the collected biological material can be used for future, not yet further defined research projects.
Wearable device: Basler Band (MMT 278-1 Bracelet) The multi-sensor wearable devices (Basler Band) will be provided by Manufacture Modules Technologies (MMT). The Basler Band relies on the MMT-CW287 multisensor technology to simultaneously and unobtrusively detect up to 9 core body parameters, and convey the information to physicians in a secure and GDPR- compliant fashion. It includes sensors and algorithms to measure heart rate, heart rate variability, heart rhythm, respiration rate and activity.
For validating the quality of the Basler Band, additional devices were used to collect photoplethysmographic data and tested on a limited number of patients. All devices have CE-markings to ensure the compliance with safety standards for medical devices. Basler Band version 2 consists of a sensor from the PulseWatch Model D, manufactured and developed by the CSEM (Neuchâtel, Switzerland). Basler Band version 3 consists of a sensor from the epyGuard model which is manufactured and developed by epyMetrics AG.
- Keywords
- Perioperative myocardial injury/infraction, Myocardial ischemia/diagnosis, Myocardial ischemia/epidemiology, Perioperative complications/diagnosis, PMI
- Medical subject headings
- Myocardial Ischemia, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative myocardial infarction/injury (PMI)
PMI is defined as an absolute increase in high-sensitivity cardiac troponin (hs-cTn) of the 99th percentile of healthy individuals for the respective assay above baseline cTn-value or between two postoperative values if the preoperative value was missing.
PMI will be further classified as type I myocardial infarction, type II myocardial infarction, or myocardial injury due to non-cardiac causes. Two independent cardiologists or anaesthesiologists will adjudicate all PMI cases.
Measured: 3 days after surgery
Major adverse cardiac and cerebral events (MACCE)
MACCE is defined as a composite of all-cause death, acute myocardial infarction, acute heart failure (requiring admission to a hospital or intra-hospital transfer to the internal medicine or intensive care unit), clinically relevant arrhythmias (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV)-block III, high rate atrial fibrillation/flutter requiring treatment, bradycardia requiring pacemaker, or rhythmogenic syncope) and stroke/transient ischaemic attack within one year.
Measured: 1 year
Postoperative atrial fibrillation (POAF)
POAF is defined as new-onset atrial fibrillation (AF) in the immediate postoperative period of duration/burden at least 30 minutes detected using continuous monitoring of vital signs using the wearable device (Basler Band), but not recorded and documented using the current clinical monitoring standards.
Measured: During surgery and up to 7 days after surgery or until hospital discharge.
Documentation and quantification of the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia.
Frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia detected using continuous monitoring of vital signs using the "Basler Band" throughout the whole perioperative period, and use this information to characterise PMI.
Major abnormalities will be defined as: hypotension (systolic blood pressure <85 mmHg or more than 40 mmHg lower than at the initiation of analgosedation for >10 minutes), hypertension (systolic blood pressure >190 mmHg >20 minutes), tachyarrhythmia (ventricular rate >120 for >20 minutes), bradycardia (asystole >10 s or heart rate <40/min for >30 minutes), and/or hypoxaemia (pulse oximetry <85% for >20 minutes).
Measured: During surgery and up to 7 days after surgery or until discharge.
Comparison of the incidence and prognostic impact of PMI detected by using different troponin assays
Comparison of the incidence and prognostic impact of PMI detected by using different high-sensitivity cardiac troponin I (hs-cTnI) assays in parallel to the clinical PMI-screening using high-sensitivity cardiac troponin T (hs-cTnT) assays.
Measured: 3 days after surgery
Using biomarkers as tools for prediction of major cardiac complications in patients undergoing non-cardiac surgery
Evaluation of the incremental value of additional cardiovascular biomarkers and continuous vital sign monitoring in the prediction of PMI and other cardiac complications, as well as the prediction of death, and the understanding of the pathophysiology of PMI.
Measured: 3 days after surgery
Secondary outcomes (1)
Number of patients with PMI with ischemic symptoms and signs detected in a screening program in high-risk patients undergoing major non-cardiac surgery
Patients with PMI are evaluated for: presence of chest pain, atypical symptoms, palpitations, dyspnea, edema, or nausea; ST-changes, Q-waves, T-wave abnormalities, new bundle branch block.
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start20 Sep 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 875 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Müller, MD, Prof, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866874
- Sponsor's protocol ID
- PMI VITAL
- Other IDs
- 2021-02274
- Acronym
- PMI-VITAL
- Status last verified
- Jan 2025
- First submitted
- 10 May 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haziri F, Durak K, Glarner N, Ergin E, Burri-Winkler K, Kaplan E, Thommen V, Pargger M, Hure G, Giger RV, Bolliger D, Steiner LA, Mujagic E, Lardinois D, Scharen S, Mueller A, Kunz M, Stolte T, Mahfoud F, Strebel I, Puelacher C, Gualandro DM, Mueller C. Perioperative discontinuation of SGLT2-inhibitors and cardiac complications after noncardiac surgery: secondary analysis of two prospective observational cohort studies. Br J Anaesth. 2026 Aug;137(2):440-449. doi: 10.1016/j.bja.2026.05.004. Epub 2026 Jun 11.
PubMed 42270529
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Vital Signs for Improved Phenotyping of Perioperative Myocardial Infarction/Injury After Noncardiac Surgery in High Risk Patients: PMI-VITAL
- ClinicalTrials.gov ID
- NCT05866874
- Acronym / sponsor ID
- PMI-VITAL / PMI VITAL
- Keywords
- Perioperative myocardial injury/infraction, Myocardial ischemia/diagnosis, Myocardial ischemia/epidemiology, Perioperative complications/diagnosis, PMI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 875 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 May 2023 (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.
The goal of this observational prospective cohort study is to learn about the pathophysiology of perioperative myocardial infarction/injury in high-risk patients undergoing major non-cardiac surgery.
Participants will:
- Wear wearable device (Basler Band) for up to seven days after the operation or until hospital discharge
- Provide three blood samples. A venous specimen of blood (25 mL) will be collected preoperatively and on postoperative days 1 and 2.
- Be contacted to answer a questionnaire one year after the surgery.
Detailed description
Background:
With over 300 million surgical procedures performed annually, surgery and anaesthesia provide major medical value to patients, especially in resource-rich countries like Switzerland with about 900.000 procedures done per year. Demand for surgery is expected to further increase in the coming years due to the aging of the population and the availability of novel less invasive surgical procedures making even elderly patients with extensive comorbidities possibly eligible for surgery.
Perioperative myocardial infarction/injury (PMI) has been identified as a major contributor to perioperative mortality. First studies estimated that PMI is a major contributor to 34-42% of all deaths following noncardiac surgery within 30 days. Recent research by several groups including ours has highlighted that PMI is not a homogenous disease entity, but seems to comprise several underlying pathophysiologies. These include type I myocardial infarction due to atherothrombosis, type II myocardial infarction due to myocardial oxygen supply-demand mismatch, tachyarrhythmias, acute heart failure, and PMI due to primarily extra-cardiac disorders such as severe sepsis, stroke, or pulmonary embolism. Unfortunately, the underlying pathophysiology of PMI remains unknown in many patients. This is among other things due to incomplete recording and documentation of patient vital signs including heart rate, blood pressure, and oxygen saturation e.g. in the postoperative period once patients leave the operating room. Identifying the underlying trigger of PMI is a prerequisite for causal therapy and prevention.
Objectives:
- To continuously document and quantify the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxemia, that are not recorded and documented using the current clinical monitoring standards, but detected using continuous monitoring of vital signs using the wearable device (Basler Band) throughout the whole perioperative period.
- To validate the diagnosis of PMI within a screening program in high-risk patients undergoing major noncardiac surgery with other troponin assays.
- To evaluate the diagnostic and predictive utility of novel biochemical markers.
- To technically validate intraoperative haemodynamic measurements of wearable device by comparing them to routinely obtained intraoperative haemodynamics.
Number of Participants:
We expect PMI to occur in 15-20% of patients. We expect 35% of cases to fall in the adjudication category of "cardiac, unknown" in first adjudication. Continuous vital signs and biomarkers are expected to allow to adjudicate ~33% of PMI from the category "unknown" to any of the other definite categories. Using a Chi-square test for final analysis, we calculate a needed sample size of approximately 125 PMI. With worst-case PMI-incidence of 15%, and a buffer of 5% additional cases to compensate for technical difficulties which are expected to arise with continuous monitoring, we require a total sample size of 875 patients included into the cohort.
Methodology:
After obtaining written informed consent, a venous specimen of blood (25 mL) is collected preoperatively and the patient will receive the wearable device. Further venous blood samples are withdrawn on postoperative days 1 and 2 (each 25 mL). As all patients will be included into the routine troponin screening implemented at the University Hospital Basel, blood draws will be coordinated with routine blood draws as far as possible. The wearable device will be worn until seven days after surgery or until hospital discharge.
Project duration for each patient will be approximately one week plus the answering of a questionnaire one year after the surgery.
Biobank:
One preoperative and two postoperative venous blood samples are collected into plastic tubes containing sodium citrate 1:10 (4.3 mL), heparin (4.7 mL), ethylenediaminetetraacetic acid (EDTA, 7.5 mL) and a clotting activator for serum diagnostics (7.5 mL). The biological material collected will be coded and stored on study site (or in the biobank of the University Hospital Basel) for an indefinite period of time. During this timeframe the collected biological material can be used for future, not yet further defined research projects.
Wearable device: Basler Band (MMT 278-1 Bracelet) The multi-sensor wearable devices (Basler Band) will be provided by Manufacture Modules Technologies (MMT). The Basler Band relies on the MMT-CW287 multisensor technology to simultaneously and unobtrusively detect up to 9 core body parameters, and convey the information to physicians in a secure and GDPR- compliant fashion. It includes sensors and algorithms to measure heart rate, heart rate variability, heart rhythm, respiration rate and activity.
For validating the quality of the Basler Band, additional devices were used to collect photoplethysmographic data and tested on a limited number of patients. All devices have CE-markings to ensure the compliance with safety standards for medical devices. Basler Band version 2 consists of a sensor from the PulseWatch Model D, manufactured and developed by the CSEM (Neuchâtel, Switzerland). Basler Band version 3 consists of a sensor from the epyGuard model which is manufactured and developed by epyMetrics AG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients that underwent a systematic approach to PMI detection at the hospital as clinical routine will be included.
Key inclusion criteria (6 listed)
- Patient eligible for routine PMI-screening
- Patient requiring hospitalisation with ≥ 2 overnight stays after surgery
- Age ≥ 40 years to ≤ 85 AND history of coronary artery disease (CAD), peripheral artery disease (PAD), cerebrovascular disease/stroke, insulin-dependent diabetes mellitus (IDDM), or chronic heart failure (CHF)
- Elective surgery
- Patients undergoing orthopaedic, traumatology, vascular, spinal, thoracic, neurosurgical, urological or visceral surgery
Key exclusion criteria (5 listed)
- Patient's refusal
- Heart surgery, cardiac arrest, acute mycardial infarction (AMI), cardiac valve intervention, or cardiac catheter ablation within 14 days prior to surgery OR involvement of heart surgery at index surgery OR surgery planned on cardiopulmonary bypass
- Patients undergoing plastic/reconstructive, ophthalmologic, dental, hand surgery, or ear-nose-and-throat surgery
- Chronic renal failure on dialysis, unless undergoing renal transplant surgery
- Moderate to severe dementia
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
Perioperative myocardial infarction/injury (PMI)
Time frame: 3 days after surgery
PMI is defined as an absolute increase in high-sensitivity cardiac troponin (hs-cTn) of the 99th percentile of healthy individuals for the respective assay above baseline cTn-value or between two postoperative values if the preoperative value was missing. PMI will be further classified as type I myocardial infarction, type II myocardial infarction, or myocardial injury due to non-cardiac causes. Two independent cardiologists or anaesthesiologists will adjudicate all PMI cases.
Major adverse cardiac and cerebral events (MACCE)
Time frame: 1 year
MACCE is defined as a composite of all-cause death, acute myocardial infarction, acute heart failure (requiring admission to a hospital or intra-hospital transfer to the internal medicine or intensive care unit), clinically relevant arrhythmias (cardiac arrest, sustained ventricular tachycardia, atrioventricular (AV)-block III, high rate atrial fibrillation/flutter requiring treatment, bradycardia requiring pacemaker, or rhythmogenic syncope) and stroke/transient ischaemic attack within one year.
Postoperative atrial fibrillation (POAF)
Time frame: During surgery and up to 7 days after surgery or until hospital discharge.
POAF is defined as new-onset atrial fibrillation (AF) in the immediate postoperative period of duration/burden at least 30 minutes detected using continuous monitoring of vital signs using the wearable device (Basler Band), but not recorded and documented using the current clinical monitoring standards.
Documentation and quantification of the frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia.
Time frame: During surgery and up to 7 days after surgery or until discharge.
Frequency and duration of tachyarrhythmia, bradycardia, hypotension, hypertension, and/or hypoxaemia detected using continuous monitoring of vital signs using the "Basler Band" throughout the whole perioperative period, and use this information to characterise PMI. Major abnormalities will be defined as: hypotension (systolic blood pressure <85 mmHg or more than 40 mmHg lower than at the initiation of analgosedation for >10 minutes), hypertension (systolic blood pressure >190 mmHg >20 minutes), tachyarrhythmia (ventricular rate >120 for >20 minutes), bradycardia (asystole >10 s or heart rate <40/min for >30 minutes), and/or hypoxaemia (pulse oximetry <85% for >20 minutes).
Comparison of the incidence and prognostic impact of PMI detected by using different troponin assays
Time frame: 3 days after surgery
Comparison of the incidence and prognostic impact of PMI detected by using different high-sensitivity cardiac troponin I (hs-cTnI) assays in parallel to the clinical PMI-screening using high-sensitivity cardiac troponin T (hs-cTnT) assays.
Using biomarkers as tools for prediction of major cardiac complications in patients undergoing non-cardiac surgery
Time frame: 3 days after surgery
Evaluation of the incremental value of additional cardiovascular biomarkers and continuous vital sign monitoring in the prediction of PMI and other cardiac complications, as well as the prediction of death, and the understanding of the pathophysiology of PMI.
1 secondary outcome
Number of patients with PMI with ischemic symptoms and signs detected in a screening program in high-risk patients undergoing major non-cardiac surgery
Time frame: 3 days after surgery
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 28 Jan 2025.
- Derived from this study: PubMed 42270529Haziri F, Durak K, Glarner N, Ergin E, Burri-Winkler K, Kaplan E, Thommen V, Pargger M, Hure G, Giger RV, Bolliger D, Steiner LA, Mujagic E, Lardinois D, Scharen S, Mueller A, Kunz M, Stolte T, Mahfoud F, Strebel I, Puelacher C, Gualandro DM, Mueller C. Perioperative discontinuation of SGLT2-inhibitors and cardiac complications after noncardiac surgery: secondary analysis of two prospective observational cohort studies. Br J Anaesth. 2026 Aug;137(2):440-449. doi: 10.1016/j.bja.2026.05.004. Epub 2026 Jun 11.
- 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.
Christian Müller, MD, Prof principal investigator
University Hospital, Basel, Switzerland
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 Infarction and Perioperative Myocardial Injury, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 6 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 28 Jan 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 Switzerland. 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 Christian Müller, MD, Prof (+41 61 328 6549, christian.mueller@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative myocardial infarction/injury (PMI) (time frame: 3 days after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866874, which also lists 1 linked publication.
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 28 Jan 2025.