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Clinical Trials in China / NCT02427867
Active, not recruiting Not applicable

Ischaemic PReconditioning In Non Cardiac surgEry

NCT02427867 · tracked via the Priya Life Science China tracker
Sponsor
Università Vita-Salute San Raffaele
Phase
Not applicable
Started
2015-04
Last updated
2026-05-11

Condition(s) studied

Myocardial IschemiaSurgery

Investigational drug(s) / intervention(s)

Remote ischemic preconditioningno ischemic preconditioning

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
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

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Xijing Hospital Xi'an China
Fundación Cardioinfantil-Instituto de Cardiología Bogotá Colombia
University Hospital Centre Zagreb Zagreb Croatia
Humanitas Clinical Institute Rozzano Lombardy
Valle Olona Po hospital Busto Arsizio Varese
Ospedale Cardinal Massaia Asti Italy
Azienda Ospedaliero Universitaria Careggi Florence Italy
E.O. Ospedali Galliera Genova Italy
IRCCS San Raffaele Scientific Institute Milan Italy
Fondazione IRCCS. Istituto Neurologico Carlo Besta Milan Italy
Università degli studi della Campania Luigi Vanvitelli Naples Italy
Azienda Universitaria Ospedaliero Pisana Pisa Italy
A.O.U. Pisana Pisa Italy
Fondazione Policlinico Universitario Campus Bio-Medico di Roma Rome Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
ULSS 4 Veneto Orientale, Ospedale di San Donà di Piave San Donà di Piave Italy
Azienda Sanitaria Universitaria Friuli Centrale "Santa Maria della Misericordia" Udine Italy
Astana Medical University Astana Kazakhstan
Loginov Moscow Clinical Scientific Center Moscow Russia
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 Moscow Russia
Saint-Petersburg State University Hospital Saint Petersburg Russia
Institute of Cardiovascular Diseases "Dedinje" Belgrade Serbia
National University Hospital Singapore Singapore
Ospedale Regionale di Lugano Lugano Switzerland

More Università Vita-Salute San Raffaele trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02427867 on ClinicalTrials.gov ↗ ← All trials in China