NCT07637266

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

April 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

April 15, 2026

Last Update Submit

June 7, 2026

Conditions

Keywords

CABGCardiac magnetic resonance imagingCoronary artery diseasecardioplegia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Major Adverse Cardiac and Cerebrovascular Events

    MACCE will be adjudicated at 30 days and 6 months.

Study Arms (2)

Del Nido cardioplegia

ACTIVE COMPARATOR

CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy

Drug: Del Nido Cardioplegia Solution for myocardial protection

Blood cardioplegia

ACTIVE COMPARATOR

CABG patients receiving blood cardioplegia as the myocardial protection strategy

Drug: Blood Cardioplegia Solution for myocardial protection

Interventions

CABG patients receiving Del Nido cardioplegia as the myocardial protection strategy

Del Nido cardioplegia

Patients will receive Blood Cardioplegia Solution for myocardial protection

Blood cardioplegia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Center Zagreb

Zagreb, 10000, Croatia

RECRUITING

University Hospital Center Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Del Nido cardioplegia solution

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Hrvoje Gasparovic

    Clinical Hospital Centre Zagreb

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hrvoje Gasparovic, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Department of Cardiac Surgery

Study Record Dates

First Submitted

April 15, 2026

First Posted

June 9, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

June 9, 2026

Record last verified: 2026-06

Locations