Myocardial Biopsy in Congenital Cardiac Surgery

Does Intraoperative Myocardial Biopsy Have Any Prognostic Value in Predicting Myocardial Protection After Congenital Cardiac Surgery

Despite major advances in the technical aspects of surgical repair of congenital heart diseases, perioperative myocardial damage with low cardiac output remains the most common cause of morbidity and death after repair of congenital heart lesions.

Study Overview

• Status: Unknown
• Conditions: Myocardial Protection
• Intervention / Treatment: Procedure: myocardial biopsy

Detailed Description

Myocardial sample was obtained from the endocardial surface of the right ventricle and placed in formalin until examination under light microscopy for detection of myocyte cellular edema as a marker of ischemic changes.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time>45 minutes.

Hemodynamic stability.

Exclusion Criteria:

Previous cardiac surgery. Urgent or emergent cases. Any known allergies to components of either cardioplegia solutions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Myocardial biopsy; The specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change.	Procedure: myocardial biopsy; Myocardial cell edema either focal or diffuse was detected in histopathological examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial biopsy	Myocardial cell edema either focal or diffuse was detected in histopathological examination	within 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The inotropic score	1 point is assigned for each mcg/kg/min of dopamine and dobutamine, and 10 points is assigned for each 0.1 mcg/kg/min of epinephrine, norepinephrine, and phenylephrine. (i.e. 1 point is assigned for each 10 ng/kg/min of epinephrine, norepinephrine, and phenylephrine.	within one month
Serum cardiac troponin level	Samples for troponin I levels at baseline, 6, 12 and 24 hours after aortic cross-clamping.	first 24 hours
30-day mortality	number of patients died	30 days
Type of cardiac rhythm on return	Type of cardiac rhythm on return	within 24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): November 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (ACTUAL): July 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2018
• Last Update Submitted That Met QC Criteria: July 20, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Pediatric; Cardiopulmonary Bypass; Cardiac Protection; Myocardial biopsy
• Other Study ID Numbers: IRB00008715964

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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