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NCT Number: NCT05733208

The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery

This is a multicentre, parallel-group, randomised, sham-controlled, observer blinded trial, assessing the efficacy of remote ischemic preconditioning on preventing myocardial injury after noncardiac surgery.

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This study is active but is not currently recruiting participants.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

About this study

This is a multicentre, randomised, sham-controlled, observer blinded trial. Patients at high clinical risk for cardiovascular events and scheduled to undergo major abdominal surgery will be enrolled. A total of 766 patients are randomised (1:1 ratio) to receive RIPC or no RIPC (control) before anaesthesia induction. RIPC will comprise four alternating cycles of cuff inflation for 5 min to 200 mm Hg and deflation for 5 min. In controls, the identical looking cuff will be placed around the arm but not actually inflated for 40 minutes. The primary outcome was myocardial injury after surgery within three days of surgery. The secondary outcomes were peak plasma hs-cTnT and total hs-cTnT release during the first three days after surgery, hs-cTnT above the prognostically important thresholds, length of hospital stay after surgery, and length of stay in the intensive care unit, myocardial infarction, major adverse cardiovascular events, cardiac-related death and all cause death within 30 days, 6 months, 1 year and 2 years after surgery, postoperative morbidity and adverse events within 30 days after surgery. Besides, blood samples were stored for the other ancillary studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients at high clinical risk for cardiovascular events;
  • Patients scheduled to undergo major abdominal surgery.

Exclusion criteria

  • Immediate or urgent surgery or surgery where there is insufficient time to perform RIPC.
  • Abdominal vascular surgery, such as surgery for abdominal aortic aneurysm
  • Experience of conditions precluding the use of RIPC in both arms
  • Patients who are being treated with drugs, such as sulphonamide or nicorandil
  • With contraindications for anaesthetic regimes required in this trial.

Treatment and study plan

Remote ischemic preconditioning

Procedure

Remote ischemic preconditioning will consist of four cycles of 5-minute inflation of an blood pressure cuff on the upper arm to 200 mmHg followed by 5-minute deflation. RIPC will be performed twice, one at approximately 24 hours before anaesthesia and the other at approximately 1 hour before anaesthesia.

Sham-remote ischemic preconditioning

Procedure

The identical looking cuff will be placed around the upper arm but not actually inflated for 40 minutes. The control device's components and external appearance are identical to that of the RIPC. However, as compared to the RIPC, the blood pressure cuff's line of inflation is disconnected such that the cuff cannot be inflated. Control treatment will be performed twice, one at approximately 24 hours before anaesthesia and the other at approximately 1 hour before anaesthesia.

Primary outcomes

  1. Myocardial injury after non-cardiac surgery (MINS)

    Time frame: Within the first three days after surgery

    Number of participants with MINS, diagnosed according to the criteria established by the American Heart Association in 2021

Secondary outcomes

  1. Participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds

    Time frame: Within the first three days after surgery

    Number of participants with the concentration of hs-cTnT reaching/above the prognostically important thresholds

  2. Peak concentration of hs-cTnT within the initial 3 days after surgery

    Time frame: Within the first three days after surgery

    Peak concentration of high-sensitivity cTnT

  3. Total hs-cTnT release within the initial 3 days after surgery (area under the curve)

    Time frame: Within the first three days after surgery

    Total hs-cTnT release

  4. Length of stay in the intensive care unit

    Time frame: expected 2 days after surgery

    Length of intensive care unit stay

  5. Length of postoperative stay

    Time frame: expected 6 days after surgery

    Length of hospital stay after surgery

  6. Myocardial infarction

    Time frame: Within 30 days, 6 months, 1 year and 2 years of surgery

    Number of participants with myocardial infarction

  7. Major adverse cardiovascular events

    Time frame: Within 30 days, 6 months, 1 year and 2 years of surgery

    Cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke

  8. Cardiac-related death

    Time frame: Within 30 days, 6 months, 1 year and 2 years of surgery

    Death related by cardiac reason

  9. All deaths

    Time frame: Within 30 days, 6 months, 1 year and 2 years of surgery

    All-cause death after surgery

  10. Major postoperative morbidity

    Time frame: Within 30 days after surgery

    Major postoperative morbidity

  11. Adverse events

    Time frame: Within 30 days after surgery

    Adverse events

Other outcomes

  1. Acute kidney injury

    Time frame: Within 30 days after surgery

    Acute kidney injury

  2. Postoperative pulmonary complications

    Time frame: Within 30 days after surgery

    Postoperative pulmonary complications

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

The Effect of Remote Ischemic Preconditioning on Myocardial Injury After Noncardiac Surgery in Patients at a High Risk of Cardiac Events

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Feb 17, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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