NCT02344797

Brief Summary

Worldwide, more than 200 million patients have major non-cardiac surgery annually and a significant proportion of these patients suffer major cardiovascular complications (e.g. nonfatal myocardial infarction, cardiac arrest, vascular death) within 30 days of their surgery. Perioperative myocardial infarction is the most common cardiovascular complication and recent clinical studies have shown that even minor myocardial injury in relation to non-cardiac surgery is associated with 30-day mortality. Remote ischemic preconditioning is a procedure, which protects remote tissues and organs e.g. against ischemia-reperfusion injury. Cycles of forearm or leg ischemia and reperfusion by the inflation of a blood-pressure cuff for brief periods are the preferred method.The aim of this interventional clinical study is to determine whether remote ischemic preconditioning can reduce markers of myocardial injury in emergent or urgent non-cardiac surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
573

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

February 7, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2018

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

January 13, 2015

Last Update Submit

May 7, 2019

Conditions

Myocardial InjuryMyocardial Infarction

Keywords

PerioperativePostoperative Complications/prevention & control

Outcome Measures

Primary Outcomes (1)

  • Number of patients with myocardial injury in non-cardiac surgery

    during surgery or the first 4 days after surgery

Secondary Outcomes (9)

  • Peak plasma TnI and total TnI release (area under the curve)

    during surgery or the first 4 days after surgery

  • Endothelial dysfunction (reactive hyperemia index)

    24 hours after surgery

  • Perioperative myocardial infarction

    30 days, one year and 5 years after surgery

  • Major adverse cardiovascular events

    30 days, one year and 5 years after surgery

  • Length of postoperative hospital stay

    participants will be followed for the duration of hospital stay, an expected average of 10 days

  • +4 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Remote ischemic preconditioning, 4 cycles of 5 minutes ischemia and 5 minutes reperfusion of the forearm before surgery.

Procedure: Remote ischemic preconditioning

Control

NO INTERVENTION

Interventions

Remote ischemic preconditioningPROCEDURE

The remote ischemic preconditioning procedure is carried out immediately after the induction of regional or general anesthesia. The blood pressure cuff is placed on the upper limb. The cuff is inflated to 200 mmHg resulting in a total occlusion of the blood flow to the limb. After 5 minutes of ischemia the cuff is deflated and the limb is reperfused for 5 minutes. The procedure is carried out 4 times in a row. For patients with systolic blood pressures \>185 mmHg, the cuff will be inflated to at least 15 mmHg above the patient's systolic blood pressure.

Intervention

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients ≥ 45 years undergoing in-hospital hip fracture surgery
  • undergoing emergent or urgent surgery (i.e. emergent or urgent visitation to the Department of Orthopedic Surgery)
  • Ischemic heart disease, defined by any of the following criteria A. angina pectoris B. prior myocardial infarction C. prior percutaneous coronary intervention D. prior coronary artery bypass graft
  • Peripheral arterial disease, defined by any of the following criteria A. intermittent claudication B. reduced peripheral arterial blood flow C. prior vascular surgery due to peripheral arterial disease
  • Prior stroke OR
  • any 1 of 7 risk criteria A. age ≥70 years; B. congestive heart failure C. prior transient ischemic attack; D. diabetes and currently taking an oral hypoglycemic agent or insulin E. hypertension G. preoperative serum creatinine \>175 µmol/L (\>2.0 mg/dl) H. smoking within 2 years of surgery

You may not qualify if:

  • History of peripheral arterial disease affecting both upper limbs
  • Renal failure with eGRF\<30ml/min/1.73m2
  • Cardiogenic shock or cardiac arrest during the current hospital admission
  • Reoperation after elective surgery carried out during the current hospital admission
  • Not capable of giving informed consent after oral and written information
  • Other conditions that prevent the performance of remote ischemic preconditioning.
  • Previously included in this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Depertment of Orthopedic Surgery, Holstebro Hospital

Holstebro, Central Jutland, 7500, Denmark

Location

Department of Anesthesia, Herlev Hospital

Herlev, Region H, 2730, Denmark

Location

Department of Surgery, Koge Hospital

Køge, 4600, Denmark

Location

Related Publications (3)

  • Wahlstrom KL, Ekeloef S, Gogenur I, Munster AB. Myocardial injury after non-cardiac surgery and per operative fibrin metabolism in patients undergoing hip-fracture surgery: an observational study. Scand J Clin Lab Invest. 2023 Sep;83(5):299-308. doi: 10.1080/00365513.2023.2220970. Epub 2023 Aug 16.

    PMID: 37584362DERIVED

  • Ekeloef S, Koyuncu S, Holst-Knudsen J, Gundel O, Meyhoff CS, Homilius M, Stilling M, Ekeloef P, Munster AMB, Mathiesen O, Gogenur I. Cardiovascular events in patients undergoing hip fracture surgery treated with remote ischaemic preconditioning: 1-year follow-up of a randomised clinical trial. Anaesthesia. 2021 Aug;76(8):1042-1050. doi: 10.1111/anae.15357. Epub 2021 Jan 13.

    PMID: 33440017DERIVED

  • Ekeloef S, Homilius M, Stilling M, Ekeloef P, Koyuncu S, Munster AB, Meyhoff CS, Gundel O, Holst-Knudsen J, Mathiesen O, Gogenur I. The effect of remote ischaemic preconditioning on myocardial injury in emergency hip fracture surgery (PIXIE trial): phase II randomised clinical trial. BMJ. 2019 Dec 4;367:l6395. doi: 10.1136/bmj.l6395.

    PMID: 31801725DERIVED

MeSH Terms

Conditions

Myocardial InfarctionPostoperative Complications

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Sarah E Busch, MD

    Department of Surgery, Koge Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.d. student

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 26, 2015

Study Start

February 7, 2015

Primary Completion

September 1, 2017

Study Completion

August 24, 2018

Last Updated

May 9, 2019

Record last verified: 2019-05

Locations

DK(3)