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Myocardial Biopsy in Congenital Cardiac Surgery

A

Assiut University

Status

Unknown

Conditions

Myocardial Protection

Treatments

Procedure: myocardial biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT03595111
IRB00008715964

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

2 to 6 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Myocardial biopsy
Experimental group
Description:
The specimens were classified into three categories: normal, focal hydropic change and diffuse hydropic change.
Treatment:
Procedure: myocardial biopsy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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