NCT Number: NCT02427867
Ischaemic PReconditioning In Non Cardiac surgEry
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.
This study is active but is not currently recruiting participants.
Key information
Age range
50 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Xijing Hospital, Xi'an, China
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
no ischemic preconditioning
OtherPrimary outcomes
-
cardiac troponin
Time frame: Hospital - approximately 1 week
elevation of cardiac troponin after non-cardiac surgery
Sponsors and collaborators
Lead sponsor
Università Vita-Salute San Raffaele
Other
Registry information
Acronym: PRINCE
Important dates
- Study start
- 2015
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Apr 28, 2015
- Registry last updated
- May 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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