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Clinical Trials/NCT07637266
NCT07637266RecruitingNot Applicable

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

Klinički Bolnički Centar Zagreb1 site in 1 country60 target enrollmentStarted: June 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1

Study Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Eligibility Criteria:
  • 1. Patients with multivessel coronary artery disease scheduled for elective coronary artery bypass grafting

Exclusion Criteria

  • Left ventricular ejection fraction <30%
  • Associated cardiac procedures
  • Off-pump coronary artery bypass grafting
  • Contraindications for MRI
  • Inability to provide consent

Investigators

Sponsor
Klinički Bolnički Centar Zagreb
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hrvoje Gasparovic

Head, Department of Cardiac Surgery

Klinički Bolnički Centar Zagreb

Study Sites (1)

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