PeriOperative Medicine - Metabolic Inflexibility as a Mechanism for Myocardial Injury After Non-Cardiac Surgery (POM-MIMICS)
The goal of this observational study is to learn whether metabolic inflexibility, which means reduced ability of the body to switch between using fats and sugars for energy, is associated with myocardial injury after non-cardiac surgery (MINS) in adults undergoing major elective abdominal cancer surgery.
The main question it aims to answer is:
Does pre-operative metabolic inflexibility predict myocardial injury after non-cardiac surgery (MINS) within the first 72 hours after surgery?
Participants will continue with their usual surgical care and pre-planned CPET (which can measure metabolic flexibility). As part of the study, participants will:
- Have additional blood samples taken before and after surgery
- Have an echocardiogram and, where possible, muscle ultrasound
- Wear a wrist-worn activity monitor before surgery
- Have routine clinical and surgical information collected from their medical records
- Receive a follow-up phone call around 90 days after surgery
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
The POM-MIMIC study (PeriOperative Medicine - Metabolic Inflexibility as a mechanism for Myocardial Injury after Non-Cardiac Surgery) is a prospective, observational cohort study designed to improve perioperative risk stratification for myocardial injury after non-cardiac surgery (MINS). MINS affects up to 25% of patients undergoing major surgery and significantly increases long and short term mortality (1). Despite its clinical importance, the ability to predict MINS remains limited.
This study aims to evaluate if perioperative metabolic inflexibility, (the impaired ability of cells to adapt fuel usage to demand), is a driver of MINS. The study hypothesises that systemic metabolic dysfunction creates a state of cardiac vulnerability, priming the heart for injury when exposed to the multi-faceted immune/inflammatory and haemodynamic stressors of surgery and anaesthesia.
This study involves a prospective, multicentre observational cohort study of patients undergoing major abdominal cancer surgery. The study investigators will employ a deep, multi-modal phenotyping strategy to characterise each patient's intrinsic "metabolic resilience phenotype", with the goal of describing novel endotypes of MINS. The investigators propose that the endotypes of MINS are:
Immune mediated / inflammatory endotype: Driven by pre-existing inflammation and perioperative immune dysregulation
Metabolic / proteomic endotype: Driven by metabolic inflexibility and may involve direct metabolic injury to cardiomyocytes, lipotoxicity, oxidative stress, and unique troponin fragment signatures
Type II MI / Ischaemic-dominant endotype: Classic supply-demand mismatch (e.g. from intraoperative hypotension), likely amplified in metabolically vulnerable hearts
Mixed phenotype: A combination of the above, reflecting the interaction of metabolic, immune, and haemodynamic stressors
The phenotyping strategy will integrate:
Functional assessment: Cardiopulmonary exercise testing (CPET) to quantify metabolic flexibility via substrate utilisation
Structural assessment: Advanced imaging (CT/ultrasound) to quantify body composition, including myosteatosis and cardiac steatosis, which are markers of metabolic vulnerability
Biological assessment: High-dimensional immunophenotyping, targeted proteomics to identify novel troponin sub-fragment signatures which may reveal if injury is ischaemic, metabolic, or inflammatory, as well as in vitro studies using patient serum on human IPSC-derived cardiomyocytes to test for direct metabotoxicity
An exploratory outcome of reviewing intra-operative data for hypotension, anaesthetic type, and haemodynamics will assess for the ischaemic phenotype.
The study will recruit 300 adult patients undergoing major elective abdominal cancer surgery at UCLH and participating CIPHER-2 sites (Southampton and Plymouth). Participants will undergo routine pre-operative CPET. CPET analysis will derive VO2 peak, anaerobic threshold, metabolic crosscover and substrate utilisation metrics (fat vs carbohydrate oxidation) - the operational measure of metabolic flexibility. They will also undergo routine echocardiography and ultrasound . At this time blood sampling will be taken for targeted and untargeted metabolomics / lipidomics, biobanking of plasma/serum and PBMCs for immunophenotyping. Intra-operatively, haemodynamic monitoring as well as anaesthetic technique will be recorded. Post-operatively, hs-cTnI will be taken on days 1, 2, and 3 to assess for MINS. On days 1, 3, and 5 blood will be taken for biobanking of plasma/serum and PBMCs for immunophenotyping. On day 1 additional biomarker sampling at 24 hours will assess proteomic troponin fragmentation analysis and for mass spectrometry. Outcomes of interest include the incidence of MINS, post operative complications, length of hospital stay, and 90-day recovery metrics. See figure 1 for the participant pathway. A mechanistic substudy (n=150) will investigate inflammatory and immune profiles to explore underlying biological drivers of cardiac susceptibility to stress, these tests will utilise the blood taken for biobanking on days 1, 3, and 5. A further substudy (n=150) will assess if changes in high sensitivity troponin (hs-cTnI levels) measured before and 2 hours after CPET, are associated with the incidence of MINS. An exploratory aim of the project will be to review if there is an association between pre- and post-operative wearable signals (such as activity and heart rate) and MINS. See figure 2 for the conceptual framework of the study.
The data from samples from the MIMICS study will power four interconnected work packages:
WP1 - Immune / inflammatory predictors of MINS (n=150 sub-cohort serum samples)
WP2 - Machine learning integration for MINS prediction
WP3 - Cellular mechanisms and preclinical validation (n=150 sub-cohort serum samples)
WP4 - Targeted proteomic analysis of troponin fragmentation
Through the findings of POM-MIMIC the study investigators hope to redefine understanding of MINS by identifying endotypes. This could lead to immediate clinical benefits by enhancing preoperative risk models through integration of CPET, imaging, and blood testing. These are feasible non-invasive tests that could be rapidly adopted into standard preoperative assessments. This study has translational value as once endotype is categorised, targeted therapies which have been proven to work (such as prehabilitation for metabolic inflexibility) can be employed to reduce perioperative complications and improve outcomes. On a broader scale, this work may inform policy on perioperative cardiac care and guide future clinical trials.
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: John Whittle, MBBS, PhD
- Numer telefonu: +44 203 447 3390
- E-mail: j.whittle@ucl.ac.uk
Kopia zapasowa kontaktu do badania
- Nazwa: Rosalyn Hawkins, MBChB
- Numer telefonu: +44 203 447 3390
- E-mail: Rosalyn.hawkins.25@ucl.ac.uk
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- Adults aged 18 or over
- Scheduled for major elective abdominal cancer surgery with planned overnight admission
- Scheduled for pre-operative CPET
- Able to provide written informed consent
Exclusion Criteria:
- Less than 18 years old
- Emergency surgery
- Unable or unwilling to undergo CPET
- Pregnancy
- Active sepsis
- End-stage organ failure (e.g. on dialysis)
- Participants without the mental capacity to consent
- Diagnosis of Type 1 Myocardial Infarction meeting the 4th Universal Definition criteria during the immediate pre-operative period. (Note: Added based on MINS definition context)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Major Abdominal Cancer Surgery Cohort
Adults aged 18 years and over who are scheduled to undergo major elective abdominal cancer surgery and are already referred for routine pre-operative cardiopulmonary exercise testing (CPET).
This is an observational cohort study; no study-specific treatment or intervention will be assigned.
Participants will continue with their usual surgical and perioperative care.
The study will collect additional blood samples, imaging assessments, CPET-derived metabolic data, wearable activity data, and routine clinical information to evaluate whether pre-operative metabolic inflexibility is associated with myocardial injury after non-cardiac surgery.
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Pre-operative metabolic inflexibility will be assessed as an observational exposure using data from routine pre-operative cardiopulmonary exercise testing (CPET).
CPET-derived measures of substrate utilisation, including fat and carbohydrate oxidation, will be used to evaluate the participant's ability to switch between energy sources during physiological stress.
Additional blood-based metabolic, immune, and cardiac biomarker analyses may be used to further characterise metabolic phenotype.
No treatment, procedure, or clinical management will be assigned or altered by the study.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Development of Myocardial Injury after Non-Cardiac Surgery
Ramy czasowe: From surgery to 72 hours post surgery
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The primary outcome is the number of participants who develop myocardial injury after non-cardiac surgery (MINS) within 72 hours after surgery.
MINS means evidence of heart muscle injury after an operation that is not heart surgery.
It will be assessed using blood tests for high-sensitivity cardiac troponin I, a protein that is released into the blood when the heart muscle is injured.
Blood samples will be taken on postoperative days 1, 2, and 3. Participants will be classified as having MINS if their postoperative troponin result is above the study-defined threshold for myocardial injury and the injury is judged to be related to the perioperative period rather than another clear non-surgical cause.
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From surgery to 72 hours post surgery
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Clavien-Dindo Complication Grade
Ramy czasowe: From surgery to 30 days after surgery
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Postoperative complications will be classified using the Clavien-Dindo grading system, which grades complications according to the treatment required to manage them.
Higher grades indicate more serious complications.
The outcome will report the number of participants with major postoperative morbidity, defined as a Clavien-Dindo grade III or higher complication.
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From surgery to 30 days after surgery
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Post-Operative Morbidity Survey (POMS)
Ramy czasowe: Postoperative day 7
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Postoperative morbidity will be assessed using the Postoperative Morbidity Survey (POMS), a structured assessment that records whether participants have complications affecting different organ systems after surgery.
The outcome will report the number of participants with postoperative morbidity identified by POMS assessment.
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Postoperative day 7
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Length of Hospital Stay
Ramy czasowe: From surgery up to hospital discharge, an expected average of 7 days after surgery
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Length of hospital stay will be measured as the number of days from the date of surgery to the date the participant is discharged from hospital.
This outcome will describe how long participants remain in hospital after their operation.
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From surgery up to hospital discharge, an expected average of 7 days after surgery
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Days Alive and Out of Hospital at 90 Days
Ramy czasowe: From surgery to 90 days after surgery
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Days alive and out of hospital at 90 days, also known as DAOH90, will be measured as the number of days the participant is alive and not admitted to hospital during the first 90 days after surgery.
This outcome reflects postoperative recovery by combining survival, length of initial hospital stay, and any hospital readmissions within 90 days.
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From surgery to 90 days after surgery
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: John Whittle, MBBS, PhD, University College, London
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 200495
- CC-I23-213-CIPHER-2 (Inny numer grantu/finansowania: CIPHER-2 grant / Becton Dickinson Ltd via University Hospital Southampton)
- 363389 (Inny identyfikator: Integrated Research Application System (IRAS), UK Health Research Authority)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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