Impact of Del Nido Versus Blood Cardioplegia on Myocardial Viability Assessed With Magnetic Resonance Imaging

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.

Study Overview

• Status: Recruiting
• Conditions: CABG; Myocardial Viability
• Intervention / Treatment: Drug: Del Nido Cardioplegia Solution for myocardial protection; Drug: Blood Cardioplegia Solution for myocardial protection

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hrvoje Gasparovic, MD, PhD; Phone Number: +385 1 236 7529; Email: hrvoje.gasparovic@kbc-zagreb.hr

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • University Hospital Center Zagreb
    • Contact: Hrvoje Gasparovic, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Eligibility Criteria:

1. Patients with multivessel coronary artery disease scheduled for elective coronary artery bypass grafting

Exclusion Criteria:

1. Left ventricular ejection fraction <30%
2. Associated cardiac procedures
3. Off-pump coronary artery bypass grafting
4. Contraindications for MRI
5. Inability to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Del Nido cardioplegia; CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy	Drug: Del Nido Cardioplegia Solution for myocardial protection; CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy
Active Comparator: Blood cardioplegia; CABG patients receiving blood cardioplegia as the myocardial protection strategy	Drug: Blood Cardioplegia Solution for myocardial protection; Patients will receive Blood Cardioplegia Solution for myocardial protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial Viability Assessed by Magnetic Resonance Imaging	Myocardial Viability Assessed by Magnetic Resonance Imaging	Patients will undergo the initial cardiac MRI scan before surgery. The follow-up MRI will be scheduled approximately 4 weeks after surgical revascularization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac and Cerebrovascular Events	The secondary outcome will be a composite of mortality, periprocedural myocardial infarction, stroke, and cardiac rehospitalization	MACCE will be adjudicated at 30 days and 6 months.

Collaborators and Investigators

• Sponsor: Klinički Bolnički Centar Zagreb
• Investigators: Principal Investigator: Hrvoje Gasparovic, Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Coronary artery disease; CABG; cardioplegia; Cardiac magnetic resonance imaging
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Del Nido cardioplegia solution
• Other Study ID Numbers: 02/013 DU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No