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Heart surgery study seeks to pinpoint protection window

NCT ID NCT07249424

Knowledge-focused Sponsor: Muhammet Talha Ceran, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 80 adults having heart valve or aortic surgery to find out how long a special heart protection solution (Del Nido cardioplegia) keeps the heart safe during surgery. Researchers took blood samples at set times to see when heart injury began. The goal was to learn the exact timing of protection, not to test a new treatment. Risks were low, involving only extra blood draws.

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

80 people

The number who actually took part.

Started

Nov 2025

Finished

Feb 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

Single-center, tertiary academic cardiovascular surgery service at Necmettin Erbakan University Meram Medical Faculty Hospital (Konya, Türkiye). Consecutive adults (18-80 years) undergoing elective valve and/or thoracic aortic surgery with cardiopulmonary bypass and aortic cross-clamping, in whom Del Nido cardioplegia is used as part of routine care, are screened and, if eligible, approached for written informed consent. Approximately 80 participants are enrolled and followed through the index hospitalization; 30-day outcomes are abstracted from the medical record/standard follow-up. Observational cohort; no randomization; all treatment decisions per usual care.

Ages

18 to 80 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 18-80 years * Elective valve surgery (aortic, mitral, tricuspid), thoracic aortic surgery, or combined valve + thoracic aortic procedures * Planned cardiopulmonary bypass (CPB) with aortic cross-clamp (ACC) * Use of Del Nido cardioplegia per institutional routine * Ability to provide written informed consent (participant or legally authorized representative) Exclusion Criteria: * Isolated CABG or CABG-dominant combined procedures * Redo sternotomy * Emergency status (including shock) or preoperative mechanical circulatory support (IABP or ECMO), or anticipated need for such support * Left ventricular ejection fraction \<35% * Estimated GFR \<45 mL/min/1.73 m² * Moderate-severe chronic lung disease with significant functional limitation, or severe pulmonary hypertension * Active infection/sepsis or active infective endocarditis * Severe hepatic dysfunction, major coagulopathy, or bleeding diathesis * Pregnancy * Deep hypothermia protocols (\<28 °C) * Procedures without ACC * Preoperative cardiac troponin above the laboratory upper reference limit * Any condition that, in the judgment of the treating team, would preclude safe participation or protocol adherence

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Conditions

The condition(s) this trial relates to.

aortic disorder heart valve disorder ischemia reperfusion injury myocardial ischemia Myocardial Reperfusion Injury Postoperative Complications

As listed by the trial registrant

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

Aortic diseases Cardiopulmonary bypass Heart valve diseases Myocardial ischemia Postoperative complications (cardiopulmonary) Reperfusion injury, myocardial

Contacts and locations

Locations

  • Necmettin Erbakan University Meram Faculty of Medicine

    Konya, Konya, 42080, Turkey (Türkiye)

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