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Ischaemic PReconditioning In Non Cardiac surgEry

Ischaemic PReconditioning In Non Cardiac surgEry

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02427867
Acronym
PRINCE
Enrollment
1217
Registered
2015-04-28
Start date
2015-04-01
Completion date
2026-12-01
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Ischemia, Surgery

Keywords

remote ischemic preconditioning, non cardiac surgery, myocardial ischemia

Brief summary

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.

Interventions

OTHERRemote ischemic preconditioning

Sponsors

Università Vita-Salute San Raffaele
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cardiac troponinHospital - approximately 1 weekelevation of cardiac troponin after non-cardiac surgery

Countries

China, Colombia, Croatia, Italy, Kazakhstan, Russia, Serbia, Singapore, Switzerland

Contacts

STUDY_CHAIRAlberto Zangrillo, Prof.

Vita-Salute University of Milan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026