PeriOperative Medicine - Metabolic Inflexibility as a Mechanism for Myocardial Injury After Non-Cardiac Surgery

NCT07694453 | Not Yet Recruiting

• 3 other identifiers: 200495CC-I23-213-CIPHER-2363389
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

MINS

Keywords

MINS; metabolic flexibility; CPET; Cardiopulmonary Exercise Testing; abdominal cancer surgery; Perioperative medicine; Troponin

Outcome Measures

Primary Outcomes (1)

• Development of Myocardial Injury after Non-Cardiac Surgery

  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.

  From surgery to 72 hours post surgery

Secondary Outcomes (4)

• Clavien-Dindo Complication Grade

  From surgery to 30 days after surgery

• Post-Operative Morbidity Survey (POMS)

  Postoperative day 7

• Length of Hospital Stay

  From surgery up to hospital discharge, an expected average of 7 days after surgery

• Days Alive and Out of Hospital at 90 Days

  From surgery to 90 days after surgery

Study Arms (1)

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.

Other: Pre-operative Metabolic Inflexibility

Interventions

Pre-operative Metabolic Inflexibility OTHER

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.

Major Abdominal Cancer Surgery Cohort

Eligibility Criteria

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

Study Population

Participants will be selected from patients receiving care at University College London Hospitals and other participating CIPHER-2 network hospitals, including Southampton and Plymouth. Potential participants will be identified through perioperative/pre-operative assessment pathways, including routine cardiopulmonary exercise testing clinics for patients being assessed before major surgery.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College, London: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be retained. These may include plasma, serum, and peripheral blood mononuclear cell (PBMC) samples collected before and after surgery.

Study Officials

• John Whittle, MBBS, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Whittle, MBBS, PhD

CONTACT

+44 203 447 3390; j.whittle@ucl.ac.uk

Rosalyn Hawkins, MBChB

CONTACT

+44 203 447 3390; Rosalyn.hawkins.25@ucl.ac.uk

Study Design

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

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share