CABGNCT07637266
Impact of Del Nido Versus Blood Cardioplegia on Myocardial Viability Assessed With Magnetic Resonance Imaging
A study testing Del Nido Cardioplegia Solution for myocardial protection and Blood Cardioplegia Solution for myocardial protection in people with CABG and Myocardial Viability, run by Klinički Bolnički Centar Zagreb at 2 sites in Croatia.
Trial summary
Myocardial protection during surgical myocardial revascularization is crucial for reducing perioperative myocardial injury and improving postoperative outcomes. Blood cardioplegia represents the standard method in many centers, while del Nido cardioplegia, originally developed for the pediatric population, is… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CABG, Myocardial Viability
- What is being tested?
- Del Nido Cardioplegia Solution for myocardial protection and Blood Cardioplegia Solution for myocardial protection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCroatia
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
None listed.
Who cannot join
- Left ventricular ejection fraction <30%
- Associated cardiac procedures
- Off-pump coronary artery bypass grafting
- Contraindications for MRI
- Inability to provide consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia2 sites, 2 recruiting
- Recruiting
University Hospital Center Zagreb
Zagreb, 10000
Hrvoje Gasparovic, MD, PhD
- Recruiting
University Hospital Center Zagreb
Zagreb, 10000
About this study
Myocardial protection during surgical myocardial revascularization is crucial for reducing perioperative myocardial injury and improving postoperative outcomes. Blood cardioplegia represents the standard method in many centers, while del Nido cardioplegia, originally developed for the pediatric population, is increasingly being used in adult patients as well.
Read the detailed description
Previous studies have demonstrated reliable myocardial protection with Del Nido cardioplegia; however, most comparisons with conventional blood cardioplegia are based on biochemical markers (troponin, CK-MB) and echocardiography. Cardiac magnetic resonance imaging (CMR) enables noninvasive, highly sensitive assessment of left ventricular function as well as myocardial viability, edema, and fibrosis, and represents the gold standard for the evaluation of ventricular volumes and ejection fraction. To date, this imaging modality has not been used as a method for comparing different myocardial protection strategies in the context of various cardioplegic solutions.
The study will include patients with isolated coronary artery disease who are scheduled for surgical myocardial revascularization. Exclusion criteria will include the need for concomitant valve, aortic, or other cardiac surgery, as well as patients planned for myocardial revascularization without the use of cardiopulmonary bypass. Additionally, patients with contraindications to CMR will be excluded from the study.
- Conditions
- CABG, Myocardial Viability
- Being tested
- Del Nido Cardioplegia Solution for myocardial protection, Blood Cardioplegia Solution for myocardial protection
- Keywords
- CABG, Cardiac magnetic resonance imaging, Coronary artery disease, cardioplegia
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Del Nido Cardioplegia Solution for myocardial protectionDrug
CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy
Blood Cardioplegia Solution for myocardial protectionDrug
Patients will receive Blood Cardioplegia Solution for myocardial protection
| Study group | Role | What they receive |
|---|---|---|
| Del Nido cardioplegia | Active comparator | CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy Receives: Drug: Del Nido Cardioplegia Solution for myocardial protection |
| Blood cardioplegia | Active comparator | CABG patients receiving blood cardioplegia as the myocardial protection strategy Receives: Drug: Blood Cardioplegia Solution for myocardial protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial Viability Assessed by Magnetic Resonance Imaging
Myocardial Viability Assessed by Magnetic Resonance Imaging
Measured: Patients will undergo the initial cardiac MRI scan before surgery. The follow-up MRI will be scheduled approximately 4 weeks after surgical revascularization.
Secondary outcomes (1)
Major Adverse Cardiac and Cerebrovascular Events
The secondary outcome will be a composite of mortality, periprocedural myocardial infarction, stroke, and cardiac rehospitalization
Measured: MACCE will be adjudicated at 30 days and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinički Bolnički Centar Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hrvoje Gasparovic, Klinički Bolnički Centar Zagreb
- Investigators
- Hrvoje Gasparovic, Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637266
- Sponsor's protocol ID
- 02/013 DU
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Del Nido Versus Blood Cardioplegia on Myocardial Viability Assessed With Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT07637266
- Acronym / sponsor ID
- 02/013 DU
- Conditions
- CABG, Myocardial Viability
- Keywords
- CABG, Cardiac magnetic resonance imaging, Coronary artery disease, cardioplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Klinički Bolnički Centar ZagrebUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Jun 2026 (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.
Myocardial protection during surgical myocardial revascularization is crucial for reducing perioperative myocardial injury and improving postoperative outcomes. Blood cardioplegia represents the standard method in many centers, while del Nido cardioplegia, originally developed for the pediatric population, is increasingly being used in adult patients as well.
Detailed description
Previous studies have demonstrated reliable myocardial protection with Del Nido cardioplegia; however, most comparisons with conventional blood cardioplegia are based on biochemical markers (troponin, CK-MB) and echocardiography. Cardiac magnetic resonance imaging (CMR) enables noninvasive, highly sensitive assessment of left ventricular function as well as myocardial viability, edema, and fibrosis, and represents the gold standard for the evaluation of ventricular volumes and ejection fraction. To date, this imaging modality has not been used as a method for comparing different myocardial protection strategies in the context of various cardioplegic solutions.
The study will include patients with isolated coronary artery disease who are scheduled for surgical myocardial revascularization. Exclusion criteria will include the need for concomitant valve, aortic, or other cardiac surgery, as well as patients planned for myocardial revascularization without the use of cardiopulmonary bypass. Additionally, patients with contraindications to CMR will be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Del Nido cardioplegia | Active comparator | Drug: Del Nido Cardioplegia Solution for myocardial protectionCABG patients receiving Del Nido cardioplegia as the myocardial protection strategy |
| Blood cardioplegia | Active comparator | Drug: Blood Cardioplegia Solution for myocardial protectionCABG patients receiving blood cardioplegia as the myocardial protection strategy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Left ventricular ejection fraction <30%
- Associated cardiac procedures
- Off-pump coronary artery bypass grafting
- Contraindications for MRI
- Inability to provide 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 |
|---|---|---|
| Del Nido Cardioplegia Solution for myocardial protectionCABG patients receiving Del Nido cardioplegia as the myocardial protection strategy | Drug | Del Nido cardioplegia |
| Blood Cardioplegia Solution for myocardial protectionPatients will receive Blood Cardioplegia Solution for myocardial protection | Drug | Blood cardioplegia |
Primary outcome
Myocardial Viability Assessed by Magnetic Resonance Imaging
Time frame: Patients will undergo the initial cardiac MRI scan before surgery. The follow-up MRI will be scheduled approximately 4 weeks after surgical revascularization.
Myocardial Viability Assessed by Magnetic Resonance Imaging
1 secondary outcome
Major Adverse Cardiac and Cerebrovascular Events
Time frame: MACCE will be adjudicated at 30 days and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for CABG
Not yet recruitingPhase 4
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Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
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Thiamine Intervention and Coronary Artery Bypass Grafting
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Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
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Coronary Artery Bypass Graft (CABG)
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.
Hrvoje Gasparovic principal investigator
Clinical Hospital Centre Zagreb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Del Nido Cardioplegia Solution for myocardial protection and Blood Cardioplegia Solution for myocardial protection in people with CABG and Myocardial Viability, run by Klinički Bolnički Centar Zagreb at 2 sites in Croatia.
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 0 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hrvoje Gasparovic, MD, PhD (+385 1 236 7529, hrvoje.gasparovic@kbc-zagreb.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial Viability Assessed by Magnetic Resonance Imaging (time frame: Patients will undergo the initial cardiac MRI scan before surgery. The follow-up MRI will be scheduled approximately 4 weeks after surgical revascularization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2026.