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Ischaemic PReconditioning In Non Cardiac surgEry

Study acronym: PRINCE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study completion date: Dec 2025 to Dec 2026v23
  2. Minor Study sites: 25 to 26v22
  3. Minor Study sites: 8 to 25v21
  4. Minor Trial status: Recruiting to Active, Not Recruitingv20 Show 4 more changesShow less
    • Enrollment target: estimated 1100 to confirmed 1217
    • Study completion date: Feb 2025 to Dec 2025
    • Site details revised at 8 of 8 sites
    • Publications revised (3)
  5. Minor Re-verified, no change to tracked fieldsv19
Show 17 earlier versionsHide 17 earlier versions
  1. Notable Primary completion date: May 2023 to Jan 2025
    • Study completion date: Jun 2023 to Feb 2025
    v18
  2. Minor Study sites: 5 to 8v17
  3. Minor Study sites: 1 to 5v16
  4. Notable Primary completion date: May 2021 to May 2023
    • Study completion date: Jun 2021 to Jun 2023
    v15
  5. Minor 7 versions Re-verified since Sep 26, 2018, no change to tracked fieldsv8-v14
  6. Notable Primary completion date: Apr 2018 to May 2021
    • Study completion date: May 2018 to Jun 2021
    v7
  7. Minor 5 versions Re-verified since Apr 28, 2015, no change to tracked fieldsv2-v6
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02427867
Lead Sponsor Università Vita-Salute San Raffaele
Conditions
(from sponsor)
Myocardial Ischemia, Surgery
Related terms Myocardial Ischemia
Enrollment 1,217 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov