Perioperative Reduction of Inapparent Myocardial Injury

Perioperative Myocardial Injury Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850927
• Other study ID #: LSRG-002
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: August 29, 2017
• Start date: June 2013
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: London Surgical Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Myocardial Injury
• Wounds and Injuries

Intervention

Procedure:
• Remote ischaemic preconditioning

• Control

Locations

Country	Name	City	State
United Kingdom	Royal Berkshire Hospital	Reading	Berks

Sponsors (2)

Lead Sponsor	Collaborator
London Surgical Research Group	Royal Berkshire NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak post-operative troponin (ng/L)		At 6-12, 24, 48, 72h
Secondary	Any major adverse cardiovascular events	"MACCE" - defined as any new arrhythmia, myocardial infarction, congestive heart failure, angina, stroke or non-fatal cardiac arrest, or cerebrovascular or cardiovascular death	30 days
Secondary	Any serious surgical complications	'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).	30 days
Secondary	Area-under-the-curve post-operative troponin (ng/L)		72 hours
Secondary	Positive post-operative troponin (binary endpoint, >20ng/L)		72 hours