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NCT Number: NCT01850927

Perioperative Reduction of Inapparent Myocardial Injury

Recent data suggests that subclinical myocardial injury occurs in patients undergoing major abdominal surgery, and the degree of damage is proportionally linked to morbidity and mortality in the short and medium terms. Therefore, new methods of limiting myocardial damage are urgently needed.

Ischemic preconditioning is a phenomenon whereby a brief non-lethal ischemia-reperfusion stimulus gives a protective effect to further ischemic insults. In remote ischemic preconditioning (RIPC), this initial stimulus is carried out away from the region of interest, normally a limb. In meta-analysed syntheses the effect size of RIPC in reducing cardiac damage during bypass grafting, as characterised by troponin release, seems to be about 35%.

The PRIME Study will assess the value of RIPC in reducing subclinical myocardial injury in patients undergoing major abdominal surgery. Post-operative troponin release will be used as a surrogate marker of myocardial damage. There is no good data on which to build a reliable sample size calculation, therefore we estimated samples sizes using supplementary data from the recent VISION study. The investigators intend to build a clinically powered study from the results of this study.

Study design will be by single-centre single-blind randomised control trial. Allocation will be 1:1. All treatments will be carried after induction of anaesthesia, prior to surgery. In the RIPC-treatment group, a blood pressure cuff inflated on an upper limb to 200mmHg for 5 minutes, and then deflated for 5 minutes, repeated in three cycles. In the control group, the blood pressure cuff will not be inflated, but the patient will remain under anaesthesia for the same amount of time.

Primary endpoint will be peak post-operative 5th generation hs-TnT (highly sensitive Troponin-T, ng/ml). Secondary endpoint will be hs-TnT area-under-the-curve, major adverse cardiovascular events, serious surgical complications, non-cardiovascular death, quality of life, and length of stay.

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Key information

Conditions

Perioperative Myocardial Injury

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Berkshire Hospital

Reading, Berks, RM7 0AG, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • is ≥ 45 years old;
  • is undergoing elective major colorectal or upper GI surgery.

Exclusion criteria

  • Diabetic patients that are taking glibenclamide medication
  • Patients with upper limb peripheral vascular disease, including those with arteriovenous fistula for dialysis
  • Untreated hypertension (defined as two or more readings >180mmHg systolic on admission for surgery)
  • Current participation in any study investigating troponin levels or ischaemic preconditioning
  • Unable or lacks capacity to give informed consent to participation

Treatment and study plan

Remote ischaemic preconditioning

Procedure

Control

Procedure

Primary outcomes

  1. Peak post-operative troponin (ng/L)

    Time frame: At 6-12, 24, 48, 72h

Secondary outcomes

  1. Any major adverse cardiovascular events

    Time frame: 30 days

    "MACCE" - defined as any new arrhythmia, myocardial infarction, congestive heart failure, angina, stroke or non-fatal cardiac arrest, or cerebrovascular or cardiovascular death

  2. Any serious surgical complications

    Time frame: 30 days

    'SSG' - defined as any post-operative complication requiring radiological, surgical, or endoscopic intervention, or intensive care, or leading to non-vascular death (i.e. Calvien-Dindo III-V).

  3. Area-under-the-curve post-operative troponin (ng/L)

    Time frame: 72 hours

  4. Positive post-operative troponin (binary endpoint, >20ng/L)

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

London Surgical Research Group

Other

Collaborators

  • Royal Berkshire NHS Foundation Trust

Registry information

Official study title

Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial

Acronym: PRIME

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 10, 2013
Registry last updated
Aug 31, 2017

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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