NCT03460938: MICOLON2

Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia

Completed NA Last updated 23 April 2019

What this trial tests

NA trial testing Remote ischemic preconditioning in Myocardial Ischemia in 90 participants. Completed in 1 April 2019.

Timeline

8 March 2017

Primary endpoint
1 April 2019

1 April 2019

Quick facts

Lead sponsor	St. Antonius Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	90
Start date	8 March 2017
Primary completion	1 April 2019
Estimated completion	1 April 2019
Sites	1 location across Netherlands

Drugs / interventions tested

• Remote ischemic preconditioning

Conditions studied

• Myocardial Ischemia — all drugs for Myocardial Ischemia →
• Inflammatory Response — all drugs for Inflammatory Response →

Sponsor

St. Antonius Hospital

Who can join

18 and older, any sex, with Myocardial Ischemia or Inflammatory Response. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

High-risk abdominal surgery is frequently complicated by postoperative complications, such as sepsis, pneumonia or anastomotic dehiscence. Asymptomatic myocardial injury after abdominal surgery (MINS) predicts non-cardiac complications. The etiology of MINS in abdominal surgery patients is unknown. Remote ischemic preconditioning (RIPC) is a physiologic mechanism that exposes tissues to brief periods of non-lethal ischemia and reperfusion, creating resistence for future serious ischemic insults. RIPC in patients after cardiac or aortic surgery is associated with a protective effect on the heart. The effect of RIPC in abdominal surgery patients is unknown.

Objective of the study: To determine the effect of RIPC on MINS in patients after pancreatic sugery.

Study design: Randomised controlled parallel group mono-center pilot study.

Study population: 90 adult patients scheduled for elective pancreaticoduodenectomy in St. Antonius Hospital (45 in the intervention group and 45 in the control group).

Intervention: RIPC: 3 periods of 5 minutes of ischemia followed by 5 minutes of reperfusion are created by inflating a blood pressure cuff on the upper extremity after induction of anesthesia and prior to surgery. In the control group a non-inflated blood pressure cuff is placed on the upper extremity for 30 minutes.

Primary study parameters/outcome of the study: Maximum postoperative concentration of high-sensitive cardiac troponin T.

Secondary study parameters/outcome of the study: Markers of inflammatory, intestinal and renal injury, postoperative complications during 30 days, length of stay and hospital mortality.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hypoxia signaling in human diseases and therapeutic targets.
   Lee JW, Ko J, Ju C, Eltzschig HK. · · 2019 · cited 272× · PMID 31221962 · DOI 10.1038/s12276-019-0235-1
2. The effect of remote ischaemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial.
   van Zeggeren L, Visser RA, Vernooij LM, Dijkstra IM, et al · · 2021 · cited 8× · PMID 33893738 · DOI 10.1093/bjsopen/zrab015
3. Is chronic inflammation a risk factor for perioperative myocardial injury or heart failure in pancreatic surgery patients?
   Reniers T, Rettig T, van Zeggeren L, Dijkstra I, et al · · 2025 · cited 1× · PMID 40491666 · DOI 10.1016/j.bjao.2025.100417
4. The effect of remote ischemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial
   van Zeggeren L, Visser RA, Vernooij LM, Dijkstra IM, et al · · 2020 · DOI 10.1101/2020.12.18.20248465