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Could a heart monitor during surgery shield patients from hidden cardiac harm?

NCT ID NCT07778914

Knowledge-focused Sponsor: Istanbul Saglik Bilimleri University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study looks at whether a special heart monitor used during pancreatic surgery can help predict if patients will have elevated troponin levels afterward—a sign of possible heart damage. It involves adults aged 45 or older (or 65+ with certain health conditions) undergoing a pancreaticoduodenectomy. The goal is to see if the time spent with low cardiac cycle efficiency during surgery correlates with higher troponin levels the next morning. Findings could guide future anesthesia care to reduce heart complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If a link is found, it could help doctors monitor heart function during surgery to reduce the risk of heart damage after pancreatic operations.
What could go wrong
This is a small observational study, so it may not prove cause and effect. Results might not apply to all patients or surgeries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

51 people

The number who actually took part.

Started

Sep 2025

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study included high-risk adult patients scheduled to undergo pancreaticoduodenectomy at Istanbul Basaksehir Cam and Sakura City Hospital. Eligible patients were aged ≥65 years or aged ≥45 years with at least one predefined comorbidity associated with increased cardiovascular risk. Patients were prospectively followed from the intraoperative period through the first postoperative morning, with continuous intraoperative hemodynamic monitoring and postoperative high-sensitivity cardiac troponin T (hsTnT) assessment.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Age ≥65 years, or age ≥45 years with at least one predefined comorbidity. Scheduled to undergo pancreaticoduodenectomy. Presence of at least one of the following comorbidities in patients aged ≥45 years: * Diabetes mellitus * Hypertension * Coronary artery disease * Congestive heart failure * Moderate-to-severe valvular heart disease * Peripheral arterial disease * Moderate-to-severe pulmonary hypertension * Previous cerebrovascular accident occurring \>1 month before surgery * Previous pulmonary embolism occurring \>1 month before surgery * Provision of written informed consent. Exclusion Criteria: * Atrial fibrillation on the day of surgery. * Sepsis on the day of surgery. * Pulmonary embolism on the day of surgery. * Pulmonary embolism within the preceding 1 month. * Acute coronary syndrome within the preceding 1 month. * Cerebrovascular accident within the preceding 1 month. * Preoperative hsTnT \>65 ng/L. * Glomerular filtration rate \<60 mL/min. * Newly developed postoperative arrhythmia or embolic event that could influence postoperative hsTnT concentrations. * Planned pancreaticoduodenectomy being abandoned after laparotomy.

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Conditions

The condition(s) this trial relates to.

pancreas disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemodynamic monitoring MINS Pancreas disease Troponin T

Contacts and locations

Locations

  • Basaksehir Cam and Sakura City Hospital

    Istanbul, Istanbul, 34480, Turkey (Türkiye)

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