Heart Valve DiseasesDN-TIME-2025NCT07249424
Effective Myocardial Protection Time of Del Nido Cardioplegia in Adult Cardiac Surgery
An observational study of Heart Valve Diseases and Aortic Diseases, run by Muhammet Talha Ceran, MD at 1 site in Turkey (Türkiye).
Trial summary
This single-center, prospective, observational cohort study quantifies the effective myocardial protection window of Del Nido cardioplegia during adult open-heart surgery performed under cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Valve Diseases, Aortic Diseases, Myocardial Ischemia
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2025to 16 Feb 2026
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University Meram Faculty of Medicine
Konya, Konya, 42080
About this study
Official title: Evaluation of the Effective Myocardial Protection Duration of Del Nido Cardioplegia: A Prospective Observational Study in Adult Patients Undergoing Cardiac Surgery
This single-center, prospective, observational cohort study quantifies the effective myocardial protection window of Del Nido cardioplegia during adult open-heart surgery performed under cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC). Without altering routine care, time-stamped high-sensitivity cardiac troponin (hs-cTn) measurements will be obtained at predefined intraoperative and early postoperative intervals to identify the inflection ("change-point") at which biochemical evidence of ischemic injury begins to rise. Eighty adults undergoing elective valve and/or thoracic aortic procedures with Del Nido cardioplegia will be enrolled. The primary endpoint is the intraoperative hs-cTn change-point time referenced to ACC. Secondary endpoints include associations between change-point and ACC duration, the presence/timing of any re-dose, and early clinical outcomes (e.g., low cardiac output syndrome, maximum VIS in the first 24 h, new arrhythmia or pacemaker need, acute kidney injury by KDIGO, ventilation hours, ICU/hospital length of stay, 30-day MACE and mortality). All cardioplegia choices (dose, route, temperature, re-dose decisions) remain per standard practice; no experimental therapy is administered. Risks are minimal and limited to small-volume blood sampling coordinated with routine draws.
Read the detailed description
Background and Rationale Del Nido cardioplegia is widely used in adult valve/aortic surgery to permit prolonged single-dose electrical arrest. The effective protection duration likely varies with patient and procedural factors (e.g., LV function, temperature, hemodilution, surgical complexity, antegrade/retrograde delivery). Many centers empirically re-dose around 60-90 minutes; however, this window may not be optimal for every case. The current study quantifies the protection window by coupling routine care with dense, time-stamped hs-troponin sampling.
Design and Setting Prospective, single-center, observational cohort conducted at Necmettin Erbakan University, Department of Cardiovascular Surgery (Türkiye).
Population Adults 18-80 years scheduled for elective valve and/or thoracic aortic surgery under CPB with ACC in which Del Nido cardioplegia is used per institutional routine. Key exclusions include isolated or CABG-dominant procedures, redo sternotomy, emergency/salvage or preoperative shock, IABP/ECMO, LVEF <35%, eGFR <45 mL/min/1.73 m², significant pulmonary or hepatic disease, major coagulopathy, active infection/sepsis or endocarditis, pregnancy, and preoperative troponin elevation.
Interventions None. Cardioplegia content, dose, route (antegrade/retrograde/combined), temperature, and re-dose decisions are entirely per standard practice at the discretion of the surgical/anesthesia/perfusion team. No experimental therapy is administered.
Sampling Schedule (Biomarkers) Preoperative baseline hs-cTn; intraoperative sampling referenced to ACC at 0, 30, and 60 minutes, then intensified at 75, 90, 105, and 120 minutes. If a re-dose is administered, additional samples at pre-re-dose and +15/+30/+45/+60 minutes. Postoperative hs-cTn at approximately 6, 24, and 48 hours. Intraoperative blood is obtained preferably from the venous reservoir or existing central lines. Each draw ~3-5 mL; total additional volume ~30-40 mL. Exploratory CK-MB may be recorded where available.
Outcomes Primary outcome: intraoperative hs-cTn change-point time (minutes from ACC) identified by segmented (piecewise) trend analysis indicating the earliest sustained acceleration compatible with evolving ischemic injury.
Key secondary outcomes: (i) association between change-point and ACC duration; (ii) presence/timing of Del Nido re-dose and biochemical response to re-dose (slope change pre/post); (iii) early clinical outcomes including low cardiac output syndrome, maximum VIS in the first 24 h, new arrhythmia or pacemaker need, acute kidney injury by KDIGO, ventilation hours, ICU/hospital length of stay, re-exploration/bleeding, infection, 30-day MACE, and 30-day all-cause mortality.
Statistical Plan (Summary) Individual time series will be analyzed using segmented (piecewise) regression and/or change-point detection methods. Group-level estimates (mean protection window and variance) will be obtained via mixed-effects change-point models. Associations with durations (ACC, CPB), re-dose timing, and outcomes will use linear/quantile regression and logistic/Poisson/negative binomial models as appropriate. Missing data will be handled per predefined rules and, if needed, multiple imputation. Target enrollment is 80 participants, anticipated to provide ~80% power at α=0.05 to detect a clinically meaningful change-point and slope shift in hs-troponin trajectories.
Safety and Data Handling Risk is minimal and limited to low-volume blood sampling aligned with routine care; no experimental treatment is given. Data are recorded on standardized case report forms and stored in secure, de-identified systems compliant with local regulations. Serious adverse events are reported per institutional/authority requirements.
Significance By quantifying the actual protection window and its variability, the study is designed to inform more rational-potentially individualized-re-dose timing for Del Nido cardioplegia, aiming to reduce both under-protection (late re-dose) and workflow disruption (unnecessary early re-dose).
- Conditions
- Heart Valve Diseases, Aortic Diseases, Myocardial Ischemia, Reperfusion Injury, Myocardial, Postoperative Complications (Cardiopulmonary), Cardiopulmonary Bypass
- Keywords
- Del Nido cardioplegia, cardioplegia, aortic cross-clamp (ACC), high-sensitivity troponin, myocardial protection, cardiopulmonary bypass (CPB), aortic cross-clamp time, single-dose cardioplegia, ischemia-reperfusion, valve surgery, thoracic aortic surgery
- Medical subject headings
- Heart Valve Diseases, Aortic Diseases, Myocardial Ischemia, Myocardial Reperfusion Injury, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Del Nido Cardioplegia Cohort | Adults undergoing elective valve and/or thoracic aortic surgery under CPB with ACC in which Del Nido cardioplegia is used per routine practice. No experimental therapy; only study-specific blood sampling for hs-troponin at predefined times. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative hs-troponin change-point time (minutes from ACC)
For each participant, serial hs-cTn values obtained at ACC 0/30/60/75/90/105/120 minutes (and at re-dose pre/+15/+30/+45/+60 when applicable) will be modeled with segmented (piecewise) regression. The change-point is defined as the earliest time with a statistically significant increase in slope indicating evolving myocardial injury. Unit: minutes; lower values reflect earlier loss of protection.
Measured: From aortic cross-clamp (ACC) application to 120 minutes intraoperatively; if a re-dose is given, up to 60 minutes after the re-dose within the same operation.
Secondary outcomes (4)
Biochemical response to re-dose (slope change in hs-troponin)
Within-subject comparison of hs-cTn trajectory slope before vs after re-dose using segmented regression. Metric: difference in slopes (ng/L per minute).
Measured: From re-dose (time 0) to +60 minutes intraoperatively.
Peak postoperative hs-troponin (0-48 h)
Maximum measured hs-cTn (ng/L) within the first 48 hours after surgery.
Measured: From end of surgery to 48 hours postoperatively (samples ~6, 24, 48 h).
Low Cardiac Output Syndrome (LCOS) within 24 hours
LCOS defined as any of the following: (a) maximum vasoactive-inotropic score (VIS) ≥15 for ≥2 consecutive hours; or (b) initiation of mechanical circulatory support (IABP/ECMO); or (c) cardiac index <2.2 L/min/m² with clinical hypoperfusion requiring inotrope/vasopressor escalation. Outcome reported as proportion of participants meeting criteria.
Measured: First 24 postoperative hours.
30-day major adverse cardiovascular events (MACE)
Composite of all-cause death, non-fatal myocardial infarction (per institutional cardiac-surgery definition), and stroke/TIA. Reported as proportion of participants; components also summarized separately.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start12 Nov 2025
- Primary completion15 Jan 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammet Talha Ceran, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammet Talha Ceran, MD, Necmettin Erbakan University
- Investigators
- Yüksel Dereli, Prof. Dr., Principal investigator, Necmettin Erbakan University, Dept. of Cardiovascular SurgeryMuhammet Talha Ceran, Principal investigator, Necmettin Erbakan University, Dept. of Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249424
- Sponsor's protocol ID
- E-40209705-050.01-1123786
- Acronym
- DN-TIME-2025
- Status last verified
- Apr 2026
- First submitted
- 18 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and key secondary outcomes (time-stamped hs-troponin values, basic demographics, operative variables, and early postoperative outcomes). Data will be shared in compliance with local regulations (e.g., KVKK) and institutional policies.
Publications
Devereaux PJ, Lamy A, Chan MTV, Allard RV, Lomivorotov VV, Landoni G, Zheng H, Paparella D, McGillion MH, Belley-Cote EP, Parlow JL, Underwood MJ, Wang CY, Dvirnik N, Abubakirov M, Fominskiy E, Choi S, Fremes S, Monaco F, Urrutia G, Maestre M, Hajjar LA, Hillis GS, Mills NL, Margari V, Mills JD, Billing JS, Methangkool E, Polanczyk CA, Sant'Anna R, Shukevich D, Conen D, Kavsak PA, McQueen MJ, Brady K, Spence J, Le Manach Y, Mian R, Lee SF, Bangdiwala SI, Hussain S, Borges FK, Pettit S, Vincent J, Guyatt GH, Yusuf S, Alpert JS, White HD, Whitlock RP; VISION Cardiac Surgery Investigators. High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality. N Engl J Med. 2022 Mar 3;386(9):827-836. doi: 10.1056/NEJMoa2000803.
PubMed 35235725Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.
PubMed 29246552McGrath S, Alaour B, Kampourakis T, Marber M. Cardiac Troponin: Fragments of the Future? JACC Adv. 2025 May;4(5):101695. doi: 10.1016/j.jacadv.2025.101695. Epub 2025 Apr 25.
PubMed 40286361Nakao M, Morita K, Shinohara G, Kunihara T. Modified Del Nido Cardioplegia and Its Evaluation in a Piglet Model. Semin Thorac Cardiovasc Surg. 2021 Spring;33(1):84-92. doi: 10.1053/j.semtcvs.2020.03.002. Epub 2020 May 7.
PubMed 32387781Januzzi JL Jr. Troponin testing after cardiac surgery. HSR Proc Intensive Care Cardiovasc Anesth. 2009;1(3):22-32.
PubMed 23439987Eris C, Engin M, Erdolu B, Kagan As A. Comparison of del Nido Cardioplegia vs. blood cardioplegia in adult aortic surgery: Is the single-dose cardioplegia technique really advantageous? Asian J Surg. 2022 May;45(5):1122-1127. doi: 10.1016/j.asjsur.2021.09.032. Epub 2021 Oct 12.
PubMed 34649799
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effective Myocardial Protection Duration of Del Nido Cardioplegia: A Prospective Observational Study in Adult Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07249424
- Acronym / sponsor ID
- DN-TIME-2025 / E-40209705-050.01-1123786
- Conditions
- Heart Valve Diseases, Aortic Diseases, Myocardial Ischemia, Reperfusion Injury, Myocardial, Postoperative Complications (Cardiopulmonary), Cardiopulmonary Bypass
- Keywords
- Del Nido cardioplegia, cardioplegia, aortic cross-clamp (ACC), high-sensitivity troponin, myocardial protection, cardiopulmonary bypass (CPB), aortic cross-clamp time, single-dose cardioplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Muhammet Talha Ceran, MDUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 25 Nov 2025 (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.
This single-center, prospective, observational cohort study quantifies the effective myocardial protection window of Del Nido cardioplegia during adult open-heart surgery performed under cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC). Without altering routine care, time-stamped high-sensitivity cardiac troponin (hs-cTn) measurements will be obtained at predefined intraoperative and early postoperative intervals to identify the inflection ("change-point") at which biochemical evidence of ischemic injury begins to rise. Eighty adults undergoing elective valve and/or thoracic aortic procedures with Del Nido cardioplegia will be enrolled. The primary endpoint is the intraoperative hs-cTn change-point time referenced to ACC. Secondary endpoints include associations between change-point and ACC duration, the presence/timing of any re-dose, and early clinical outcomes (e.g., low cardiac output syndrome, maximum VIS in the first 24 h, new arrhythmia or pacemaker need, acute kidney injury by KDIGO, ventilation hours, ICU/hospital length of stay, 30-day MACE and mortality). All cardioplegia choices (dose, route, temperature, re-dose decisions) remain per standard practice; no experimental therapy is administered. Risks are minimal and limited to small-volume blood sampling coordinated with routine draws.
Detailed description
Background and Rationale Del Nido cardioplegia is widely used in adult valve/aortic surgery to permit prolonged single-dose electrical arrest. The effective protection duration likely varies with patient and procedural factors (e.g., LV function, temperature, hemodilution, surgical complexity, antegrade/retrograde delivery). Many centers empirically re-dose around 60-90 minutes; however, this window may not be optimal for every case. The current study quantifies the protection window by coupling routine care with dense, time-stamped hs-troponin sampling.
Design and Setting Prospective, single-center, observational cohort conducted at Necmettin Erbakan University, Department of Cardiovascular Surgery (Türkiye).
Population Adults 18-80 years scheduled for elective valve and/or thoracic aortic surgery under CPB with ACC in which Del Nido cardioplegia is used per institutional routine. Key exclusions include isolated or CABG-dominant procedures, redo sternotomy, emergency/salvage or preoperative shock, IABP/ECMO, LVEF <35%, eGFR <45 mL/min/1.73 m², significant pulmonary or hepatic disease, major coagulopathy, active infection/sepsis or endocarditis, pregnancy, and preoperative troponin elevation.
Interventions None. Cardioplegia content, dose, route (antegrade/retrograde/combined), temperature, and re-dose decisions are entirely per standard practice at the discretion of the surgical/anesthesia/perfusion team. No experimental therapy is administered.
Sampling Schedule (Biomarkers) Preoperative baseline hs-cTn; intraoperative sampling referenced to ACC at 0, 30, and 60 minutes, then intensified at 75, 90, 105, and 120 minutes. If a re-dose is administered, additional samples at pre-re-dose and +15/+30/+45/+60 minutes. Postoperative hs-cTn at approximately 6, 24, and 48 hours. Intraoperative blood is obtained preferably from the venous reservoir or existing central lines. Each draw ~3-5 mL; total additional volume ~30-40 mL. Exploratory CK-MB may be recorded where available.
Outcomes Primary outcome: intraoperative hs-cTn change-point time (minutes from ACC) identified by segmented (piecewise) trend analysis indicating the earliest sustained acceleration compatible with evolving ischemic injury.
Key secondary outcomes: (i) association between change-point and ACC duration; (ii) presence/timing of Del Nido re-dose and biochemical response to re-dose (slope change pre/post); (iii) early clinical outcomes including low cardiac output syndrome, maximum VIS in the first 24 h, new arrhythmia or pacemaker need, acute kidney injury by KDIGO, ventilation hours, ICU/hospital length of stay, re-exploration/bleeding, infection, 30-day MACE, and 30-day all-cause mortality.
Statistical Plan (Summary) Individual time series will be analyzed using segmented (piecewise) regression and/or change-point detection methods. Group-level estimates (mean protection window and variance) will be obtained via mixed-effects change-point models. Associations with durations (ACC, CPB), re-dose timing, and outcomes will use linear/quantile regression and logistic/Poisson/negative binomial models as appropriate. Missing data will be handled per predefined rules and, if needed, multiple imputation. Target enrollment is 80 participants, anticipated to provide ~80% power at α=0.05 to detect a clinically meaningful change-point and slope shift in hs-troponin trajectories.
Safety and Data Handling Risk is minimal and limited to low-volume blood sampling aligned with routine care; no experimental treatment is given. Data are recorded on standardized case report forms and stored in secure, de-identified systems compliant with local regulations. Serious adverse events are reported per institutional/authority requirements.
Significance By quantifying the actual protection window and its variability, the study is designed to inform more rational-potentially individualized-re-dose timing for Del Nido cardioplegia, aiming to reduce both under-protection (late re-dose) and workflow disruption (unnecessary early re-dose).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Del Nido Cardioplegia Cohort | – | –Adults undergoing elective valve and/or thoracic aortic surgery under CPB with ACC in which Del Nido cardioplegia is used per routine practice. No experimental therapy; only study-specific blood sampling for hs-troponin at predefined times. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative hs-troponin change-point time (minutes from ACC)
Time frame: From aortic cross-clamp (ACC) application to 120 minutes intraoperatively; if a re-dose is given, up to 60 minutes after the re-dose within the same operation.
For each participant, serial hs-cTn values obtained at ACC 0/30/60/75/90/105/120 minutes (and at re-dose pre/+15/+30/+45/+60 when applicable) will be modeled with segmented (piecewise) regression. The change-point is defined as the earliest time with a statistically significant increase in slope indicating evolving myocardial injury. Unit: minutes; lower values reflect earlier loss of protection.
4 secondary outcomes
Biochemical response to re-dose (slope change in hs-troponin)
Time frame: From re-dose (time 0) to +60 minutes intraoperatively.
Peak postoperative hs-troponin (0-48 h)
Time frame: From end of surgery to 48 hours postoperatively (samples ~6, 24, 48 h).
Low Cardiac Output Syndrome (LCOS) within 24 hours
Time frame: First 24 postoperative hours.
30-day major adverse cardiovascular events (MACE)
Time frame: 30 days after surgery
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 13 Apr 2026.
- Results publication: PubMed 35235725Devereaux PJ, Lamy A, Chan MTV, Allard RV, Lomivorotov VV, Landoni G, Zheng H, Paparella D, McGillion MH, Belley-Cote EP, Parlow JL, Underwood MJ, Wang CY, Dvirnik N, Abubakirov M, Fominskiy E, Choi S, Fremes S, Monaco F, Urrutia G, Maestre M, Hajjar LA, Hillis GS, Mills NL, Margari V, Mills JD, Billing JS, Methangkool E, Polanczyk CA, Sant'Anna R, Shukevich D, Conen D, Kavsak PA, McQueen MJ, Brady K, Spence J, Le Manach Y, Mian R, Lee SF, Bangdiwala SI, Hussain S, Borges FK, Pettit S, Vincent J, Guyatt GH, Yusuf S, Alpert JS, White HD, Whitlock RP; VISION Cardiac Surgery Investigators. High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality. N Engl J Med. 2022 Mar 3;386(9):827-836. doi: 10.1056/NEJMoa2000803.
- Results publication: PubMed 29246552Ad N, Holmes SD, Massimiano PS, Rongione AJ, Fornaresio LM, Fitzgerald D. The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1011-1018. doi: 10.1016/j.jtcvs.2017.09.146. Epub 2017 Nov 13.
- Results publication: PubMed 40286361McGrath S, Alaour B, Kampourakis T, Marber M. Cardiac Troponin: Fragments of the Future? JACC Adv. 2025 May;4(5):101695. doi: 10.1016/j.jacadv.2025.101695. Epub 2025 Apr 25.
- Results publication: PubMed 32387781Nakao M, Morita K, Shinohara G, Kunihara T. Modified Del Nido Cardioplegia and Its Evaluation in a Piglet Model. Semin Thorac Cardiovasc Surg. 2021 Spring;33(1):84-92. doi: 10.1053/j.semtcvs.2020.03.002. Epub 2020 May 7.
- Results publication: PubMed 23439987Januzzi JL Jr. Troponin testing after cardiac surgery. HSR Proc Intensive Care Cardiovasc Anesth. 2009;1(3):22-32.
- Results publication: PubMed 34649799Eris C, Engin M, Erdolu B, Kagan As A. Comparison of del Nido Cardioplegia vs. blood cardioplegia in adult aortic surgery: Is the single-dose cardioplegia technique really advantageous? Asian J Surg. 2022 May;45(5):1122-1127. doi: 10.1016/j.asjsur.2021.09.032. Epub 2021 Oct 12.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and key secondary outcomes (time-stamped hs-troponin values, basic demographics, operative variables, and early postoperative outcomes). Data will be shared in compliance with local regulations (e.g., KVKK) and institutional policies.
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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.
Yüksel Dereli, Prof. Dr. principal investigator
Necmettin Erbakan University, Dept. of Cardiovascular Surgery
Muhammet Talha Ceran principal investigator
Necmettin Erbakan University, Dept. of Cardiovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Aortic Diseases, run by Muhammet Talha Ceran, MD at 1 site in Turkey (Türkiye).
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 5 inclusion and 13 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 13 Apr 2026. 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 Turkey (Türkiye). 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?
Intraoperative hs-troponin change-point time (minutes from ACC) (time frame: From aortic cross-clamp (ACC) application to 120 minutes intraoperatively; if a re-dose is given, up to 60 minutes after the re-dose within the same operation.). 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 NCT07249424, which also lists 6 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 13 Apr 2026.