Ischaemic PReconditioning In Non Cardiac surgEry (PRINCE)

May 5, 2026 updated by: Giovanni Landoni, Università Vita-Salute San Raffaele

Several randomized trials suggested a cardioprotective beneficial effect (eg reduction in cardiac troponin release) of remote ischemic preconditioning in cardiac surgery.

Remote ischemic preconditioning by brief episodes of ischemia and reperfusion in a remote organ or vascular territory provides protection from injury by myocardial ischemia and reperfusion. In the translation of remote ischemic preconditioning from bench to bedside, the first proof of principle and small randomized controlled trials have shown a decreased release of myocardial biomarkers after aortic, congenital cardiac, adult valve and coronary artery by-pass graft surgery. This reduction in cardiac biomarkers release translated into better survival in a recent randomized trial performed in cardiac surgery. No clinical trial on remote ischemic preconditioning in non-cardiac surgery setting has been performed so far.

The investigators study wants to test, for the first time, the hypothesis that remote ischaemic preconditioning is effective in reducing cardiac damage in high risk patients undergoing non-cardiac surgery. Remote ischaemic preconditioning will be achieved by inflation of a blood-pressure cuff to 200 mm Hg to the upper arm for 5 minutes, followed by 5 minutes reperfusion while the cuff will be deflated. General anesthesia will be induced and maintained without using propofol in both groups. Cardiac troponin will be used as marker of cardiac damage. If the results of a reduction in postoperative cardiac troponin release and perioperative cardiac ischaemic events will be confirmed in a non-cardiac surgery setting, the investigators could improve a strategy to prevent perioperative cardiac complication easy to apply, safe and low cost.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1217

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Xi'an, China, 710032
        • Xijing Hospital
  • Colombia
      • Bogotá, Colombia, 110131
        • Fundación Cardioinfantil-Instituto de Cardiología
  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Centre Zagreb
  • Italy
      • Asti, Italy, 14100
        • Ospedale Cardinal Massaia
      • Florence, Italy, 50139
        • Azienda Ospedaliero Universitaria Careggi
      • Genova, Italy, 16128
        • E.O. Ospedali Galliera
      • Milan, Italy, 20132
        • IRCCS San Raffaele Scientific Institute
      • Milan, Italy, 20133
        • Fondazione IRCCS. Istituto Neurologico Carlo Besta
      • Naples, Italy, 80138
        • Università degli studi della Campania Luigi Vanvitelli
      • Pisa, Italy
        • A.O.U. Pisana
      • Pisa, Italy, 56100
        • Azienda Universitaria Ospedaliero Pisana
      • Rome, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico di Roma
      • Rome, Italy, 00136
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • San Donà di Piave, Italy, 30027
        • ULSS 4 Veneto Orientale, Ospedale di San Donà di Piave
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria Friuli Centrale "Santa Maria della Misericordia"
    • Lombardy
      • Rozzano, Lombardy, Italy, 20100
        • Humanitas Clinical Institute
    • Varese
      • Busto Arsizio, Varese, Italy
        • Valle Olona Po hospital
  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Astana Medical University
  • Russia
      • Moscow, Russia, 111123
        • Loginov Moscow Clinical Scientific Center
      • Moscow, Russia, 117152
        • Oncological Center No. 1 of the S. S. Yudin City Clinical Hospital of the Moscow Department of Health
      • Moscow, Russia
        • I.M. Sechenov First Moscow State Medical
      • Moscow, Russia
        • V.Negovsky Reanimatolgy Research Institute
      • Saint Petersburg, Russia
        • Saint-Petersburg State University Hospital
  • Serbia
      • Belgrade, Serbia
        • Institute of Cardiovascular Diseases "Dedinje"
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
  • Switzerland
      • Lugano, Switzerland
        • Ospedale Regionale di Lugano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • written informed consent
  • intermedial and high risk non cardiac surgery
  • general anesthesia
  • ongoing or recently suspended antiplatelet therapy

Exclusion Criteria:

  • pregnancy
  • planned locoregional anesthesia without general anesthesia
  • unstable or ongoing angina
  • recent (< 1 month) or ongoing acute myocardial infarction
  • inclusion in other randomised controlled studies in the previous 30 days
  • peripheral vascular disease affecting the upper limbs
  • cardiac surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remote ischemic preconditioning
Three cycles of 5 minutes ischemia will be applied to the upper left arm (or right arm or legs if the left arm will not be deemed suitable by the attending physician), achieved by inflation of a blood-pressure cuff to 200 mm Hg, followed by 5 minutes reperfusion while the cuff will be deflated.
Other: Remote ischemic preconditioning
Placebo Comparator: no ischemic preconditioning
The cuff will be placed around the arm but not inflated.
Other: no ischemic preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac troponin
Time Frame: Hospital - approximately 1 week
elevation of cardiac troponin after non-cardiac surgery
Hospital - approximately 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Investigators

  • Study Chair: Alberto Zangrillo, Prof., Vita-Salute University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

January 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimated)

April 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRINCE/43/OSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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