Myocardial IschemiaMICOLON2NCT03460938
Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia
A study testing Remote ischemic preconditioning in people with Myocardial Ischemia and Inflammatory Response, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Inflammatory Response
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Mar 2017to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective pancreaticoduodenectomy
- Age >18
Who cannot join
- No informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Remote Ischemic Preconditioning on Postoperative Myocardial Ischemia in Pancreatic Surgery: a Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Myocardial Ischemia, Inflammatory Response
- Being tested
- Remote ischemic preconditioning
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| RIPC | Experimental | Not described Receives: Procedure: Remote ischemic preconditioning |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative myocardial injury.
Maximum postoperative concentration of high-sensitive cardiac troponin T.
Measured: 48 hours
Secondary outcomes (2)
Inflammatory response
Markers of inflammation (IL6)
Measured: 48 hours
Postoperative complications
Postoperative cardiac and noncardiac complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start8 Mar 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. P. Noordzij, St. Antonius Hospital
- Investigators
- Peter Noordzij, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460938
- Sponsor's protocol ID
- NL57818.100.16
- Acronym
- MICOLON2
- Status last verified
- Apr 2019
- First submitted
- 29 Mar 2017
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reniers T, Rettig T, van Zeggeren L, Dijkstra I, Prinsze K, Molenaar I, van Santvoort H, Cremer O, Vernooij L, Noordzij P. Is chronic inflammation a risk factor for perioperative myocardial injury or heart failure in pancreatic surgery patients? BJA Open. 2025 May 19;14:100417. doi: 10.1016/j.bjao.2025.100417. eCollection 2025 Jun.
PubMed 40491666van Zeggeren L, Visser RA, Vernooij LM, Dijkstra IM, Bosma M, Molenaar Q, van Santvoort HC, Noordzij PG. The effect of remote ischaemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial. BJS Open. 2021 Mar 5;5(2):zrab015. doi: 10.1093/bjsopen/zrab015.
PubMed 33893738
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Preconditioning on Postoperative Myocardial Ischemia in Pancreatic Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03460938
- Acronym / sponsor ID
- MICOLON2 / NL57818.100.16
- Conditions
- Myocardial Ischemia, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC | Experimental | Procedure: Remote ischemic preconditioning |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective pancreaticoduodenectomy
- Age >18
Key exclusion criteria (1 listed)
- No informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic preconditioningRIPC: 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. | Procedure or surgery | RIPC |
Primary outcome
Postoperative myocardial injury.
Time frame: 48 hours
Maximum postoperative concentration of high-sensitive cardiac troponin T.
2 secondary outcomes
Inflammatory response
Time frame: 48 hours
Postoperative complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Derived from this study: PubMed 40491666Reniers T, Rettig T, van Zeggeren L, Dijkstra I, Prinsze K, Molenaar I, van Santvoort H, Cremer O, Vernooij L, Noordzij P. Is chronic inflammation a risk factor for perioperative myocardial injury or heart failure in pancreatic surgery patients? BJA Open. 2025 May 19;14:100417. doi: 10.1016/j.bjao.2025.100417. eCollection 2025 Jun.
- Derived from this study: PubMed 33893738van Zeggeren L, Visser RA, Vernooij LM, Dijkstra IM, Bosma M, Molenaar Q, van Santvoort HC, Noordzij PG. The effect of remote ischaemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial. BJS Open. 2021 Mar 5;5(2):zrab015. doi: 10.1093/bjsopen/zrab015.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Noordzij, MD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Myocardial Ischemia and Inflammatory Response, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative myocardial injury. (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03460938, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.