Perioperative Myocardial InjuryPRIMENCT01850927
Perioperative Reduction of Inapparent Myocardial Injury
A study testing Remote ischaemic preconditioning in people with Perioperative Myocardial Injury, run by London Surgical Research Group at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Perioperative Myocardial Injury
- What is being tested?
- Remote ischaemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- is ≥ 45 years old;
- is undergoing elective major colorectal or upper GI surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial
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%.
Read more
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.
- Conditions
- Perioperative Myocardial Injury
- Being tested
- Remote ischaemic preconditioning, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischaemic preconditioningProcedure or surgery
ControlProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 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. Receives: Procedure: Remote ischaemic preconditioning |
| Control | Sham comparator | 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. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak post-operative troponin (ng/L)
Measured: At 6-12, 24, 48, 72h
Secondary outcomes (4)
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
Measured: 30 days
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).
Measured: 30 days
Area-under-the-curve post-operative troponin (ng/L)
Measured: 72 hours
Positive post-operative troponin (binary endpoint, >20ng/L)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative Myocardial InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Surgical Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Andrew Walden, MBBS PhD MRCP, Study director, Royal Berkshire HospitalsStefan S Antonowicz, MBChB MRCS, Principal investigator, Royal berkshire Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850927
- Sponsor's protocol ID
- LSRG-002
- Acronym
- PRIME
- Status last verified
- Mar 2016
- First submitted
- 7 May 2013
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29945555
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Subclinical Myocardial Injury in Major Abdominal Surgery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01850927
- Acronym / sponsor ID
- PRIME / LSRG-002
- Conditions
- Perioperative Myocardial Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- London Surgical Research GroupUniversity, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Study start
- Jun 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Procedure: Remote ischaemic preconditioningPatients 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. |
| Control | Sham comparator | Procedure: ControlPatients 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- is ≥ 45 years old;
- is undergoing elective major colorectal or upper GI surgery.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischaemic preconditioning | Procedure or surgery | Intervention |
| Control | Procedure or surgery | Control |
Primary outcome
Peak post-operative troponin (ng/L)
Time frame: At 6-12, 24, 48, 72h
4 secondary outcomes
Any major adverse cardiovascular events
Time frame: 30 days
Any serious surgical complications
Time frame: 30 days
Area-under-the-curve post-operative troponin (ng/L)
Time frame: 72 hours
Positive post-operative troponin (binary endpoint, >20ng/L)
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Derived from this study: PubMed 29945555Antonowicz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Walden, MBBS PhD MRCP study director
Royal Berkshire Hospitals
Stefan S Antonowicz, MBChB MRCS principal investigator
Royal berkshire Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischaemic preconditioning in people with Perioperative Myocardial Injury, run by London Surgical Research Group at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak post-operative troponin (ng/L) (time frame: At 6-12, 24, 48, 72h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.