Myocardial Biopsy in Congenital Cardiac Surgery

Not Applicable

• Conditions: Myocardial Protection
• Interventions: Procedure: myocardial biopsy

• Registration Number: NCT03595111
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Status Verified: 2018-07
• Study Start: 2018-07
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-20
• Last Update Submitted: 2018-07-20
• Study First Posted: 2018-07-23
• Last Update Posted: 2018-07-23
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Hemodynamic stability.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myocardial biopsy	myocardial biopsy	The specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change.

Primary Outcome Measures

Name	Time	Method
Myocardial biopsy	within 24 hours	Myocardial cell edema either focal or diffuse was detected in histopathological examination

Secondary Outcome Measures

Name	Time	Method
Type of cardiac rhythm on return	within 24 hours	Type of cardiac rhythm on return
The inotropic score	within one month	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.
30-day mortality	30 days	number of patients died
Serum cardiac troponin level	first 24 hours	Samples for troponin I levels at baseline, 6, 12 and 24 hours after aortic cross-clamping.