Ischaemic PReconditioning In Non Cardiac surgEry

Surgery Clinical Trial

— PRINCE  

Official title:

Ischaemic PReconditioning In Non Cardiac surgEry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02427867
• Other study ID #: PRINCE/43/OSR
• Status: Recruiting
• Phase: N/A
• Start date: April 2015
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: Università Vita-Salute San Raffaele
• Contact: Giovanni Landoni, Prof.
• Phone: +39022643
• Email: landoni.giovanni[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Surgery

Intervention

Other:
• Remote ischemic preconditioning

• no ischemic preconditioning

Locations

Country	Name	City	State
Italy	Valle Olona Po hospital	Busto Arsizio	Varese
Italy	IRCCS San Raffaele Scientific Institute	Milan	MI
Italy	Humanitas Clinical Institute	Rozzano	Lombardy
Italy	Ospedale Santa Maria della Misericordia	Udine
Russian Federation	I.M. Sechenov First Moscow State Medical	Moscow
Russian Federation	V.Negovsky Reanimatolgy Research Institute	Moscow
Russian Federation	Saint-Petersburg State University Hospital	Saint Petersburg
Serbia	Institute of Cardiovascular Diseases "Dedinje"	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Countries where clinical trial is conducted

Italy,  Russian Federation,  Serbia, 

References & Publications (1)

Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhauser M, Peters J, Jakob H, Heusch G. Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial. Lancet. 2013 Aug 17;382(9892):597-604. doi: 10.1016/S0140-6736(13)61450-6. Erratum In: Lancet. 2013 Sep 14;382(9896):940. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac troponin	elevation of cardiac troponin after non-cardiac surgery	Hospital - approximately 1 week