Ischaemic PReconditioning In Non Cardiac surgEry (PRINCE)
Primary Purpose
Myocardial Ischemia, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Remote ischemic preconditioning
no ischemic preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Ischemia focused on measuring remote ischemic preconditioning, non cardiac surgery, myocardial ischemia
Eligibility Criteria
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
Sites / Locations
- Humanitas Clinical InstituteRecruiting
- IRCCS San Raffaele Scientific InstituteRecruiting
- Valle Olona Po hospitalRecruiting
- Ospedale Santa Maria della MisericordiaRecruiting
- I.M. Sechenov First Moscow State MedicalRecruiting
- V.Negovsky Reanimatolgy Research InstituteRecruiting
- Saint-Petersburg State University HospitalRecruiting
- Institute of Cardiovascular Diseases "Dedinje"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
remote ischemic preconditioning
no ischemic preconditioning
Arm Description
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.
The cuff will be placed around the arm but not inflated.
Outcomes
Primary Outcome Measures
cardiac troponin
elevation of cardiac troponin after non-cardiac surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT02427867
First Posted
April 15, 2015
Last Updated
December 23, 2022
Sponsor
Università Vita-Salute San Raffaele
1. Study Identification
Unique Protocol Identification Number
NCT02427867
Brief Title
Ischaemic PReconditioning In Non Cardiac surgEry
Acronym
PRINCE
Official Title
Ischaemic PReconditioning In Non Cardiac surgEry
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2015 (undefined)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Surgery
Keywords
remote ischemic preconditioning, non cardiac surgery, myocardial ischemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
remote ischemic preconditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
no ischemic preconditioning
Arm Type
Placebo Comparator
Arm Description
The cuff will be placed around the arm but not inflated.
Intervention Type
Other
Intervention Name(s)
Remote ischemic preconditioning
Intervention Type
Other
Intervention Name(s)
no ischemic preconditioning
Primary Outcome Measure Information:
Title
cardiac troponin
Description
elevation of cardiac troponin after non-cardiac surgery
Time Frame
Hospital - approximately 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Landoni, Prof.
Phone
+39022643
Ext
6151
Email
landoni.giovanni@hsr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Zangrillo, Prof.
Organizational Affiliation
Vita-Salute University of Milan
Official's Role
Study Chair
Facility Information:
Facility Name
Humanitas Clinical Institute
City
Rozzano
State/Province
Lombardy
ZIP/Postal Code
20100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimiliano Greco, MD
Facility Name
IRCCS San Raffaele Scientific Institute
City
Milan
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Landoni
Email
landoni.giovanni@hsr.it
First Name & Middle Initial & Last Name & Degree
Massimo Zambon, MD
First Name & Middle Initial & Last Name & Degree
Laura Pasin, MD
Facility Name
Valle Olona Po hospital
City
Busto Arsizio
State/Province
Varese
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel R Covello, MD
Email
daniel.covello@asst-valleolona.it
Facility Name
Ospedale Santa Maria della Misericordia
City
Udine
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiziana Bove, Prof
Facility Name
I.M. Sechenov First Moscow State Medical
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrey Yavorovskiy, MD
Facility Name
V.Negovsky Reanimatolgy Research Institute
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Levan Berikashvili, MD
Facility Name
Saint-Petersburg State University Hospital
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Efremov, MD
Facility Name
Institute of Cardiovascular Diseases "Dedinje"
City
Belgrade
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miomir Jovic, MD
First Name & Middle Initial & Last Name & Degree
Gordana Gazivoda, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23953384
Citation
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.
Results Reference
background
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Ischaemic PReconditioning In Non Cardiac surgEry
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