Perioperative Reduction of Inapparent Myocardial Injury (PRIME)
Primary Purpose
Perioperative Myocardial Injury
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Remote ischaemic preconditioning
Control
Sponsored by
About this trial
This is an interventional treatment trial for Perioperative Myocardial Injury
Eligibility Criteria
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
Sites / Locations
- Royal Berkshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Intervention
Control
Arm Description
Patients will receive remote ischaemic preconditioning prior to surgery. After the induction of anaesthesia, a blood pressure cuff will be placed on an upper arm and inflated to 200mmHg for 5 minutes, then deflated for 5 minutes, repeated for a total of 3 inflation-deflation cycles.
Patients will have the same procedure as for the intervention group, however the blood pressure cuff valve will be left open throughout the 30 minute treatment. Patients will be kept under anaesthesia for this additional time.
Outcomes
Primary Outcome Measures
Peak post-operative troponin (ng/L)
Secondary Outcome Measures
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
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).
Area-under-the-curve post-operative troponin (ng/L)
Positive post-operative troponin (binary endpoint, >20ng/L)
Full Information
NCT ID
NCT01850927
First Posted
May 7, 2013
Last Updated
August 29, 2017
Sponsor
London Surgical Research Group
Collaborators
Royal Berkshire NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01850927
Brief Title
Perioperative Reduction of Inapparent Myocardial Injury
Acronym
PRIME
Official Title
Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London Surgical Research Group
Collaborators
Royal Berkshire NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Myocardial Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Patients will receive remote ischaemic preconditioning prior to surgery. After the induction of anaesthesia, a blood pressure cuff will be placed on an upper arm and inflated to 200mmHg for 5 minutes, then deflated for 5 minutes, repeated for a total of 3 inflation-deflation cycles.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Patients will have the same procedure as for the intervention group, however the blood pressure cuff valve will be left open throughout the 30 minute treatment. Patients will be kept under anaesthesia for this additional time.
Intervention Type
Procedure
Intervention Name(s)
Remote ischaemic preconditioning
Intervention Type
Procedure
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Peak post-operative troponin (ng/L)
Time Frame
At 6-12, 24, 48, 72h
Secondary Outcome Measure Information:
Title
Any major adverse cardiovascular events
Description
"MACCE" - defined as any new arrhythmia, myocardial infarction, congestive heart failure, angina, stroke or non-fatal cardiac arrest, or cerebrovascular or cardiovascular death
Time Frame
30 days
Title
Any serious surgical complications
Description
'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).
Time Frame
30 days
Title
Area-under-the-curve post-operative troponin (ng/L)
Time Frame
72 hours
Title
Positive post-operative troponin (binary endpoint, >20ng/L)
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Walden, MBBS PhD MRCP
Organizational Affiliation
Royal Berkshire Hospitals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stefan S Antonowicz, MBChB MRCS
Organizational Affiliation
Royal berkshire Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Berkshire Hospital
City
Reading
State/Province
Berks
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29945555
Citation
Antonowicz SS, Cavallaro D, Jacques N, Brown A, Wiggins T, Haddow JB, Kapila A, Coull D, Walden A. Remote ischemic preconditioning for cardioprotection in elective inpatient abdominal surgery - a randomized controlled trial. BMC Anesthesiol. 2018 Jun 26;18(1):76. doi: 10.1186/s12871-018-0524-6.
Results Reference
derived
Learn more about this trial
Perioperative Reduction of Inapparent Myocardial Injury
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