Myocardial Biopsy in Congenital Cardiac Surgery

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03595111

Enrollment

Registered

2018-07-23

Start date

2018-07-31

Completion date

2018-12-31

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Protection

Keywords

Cardiac Protection, Pediatric, Myocardial biopsy, Cardiopulmonary Bypass

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.

Interventions

PROCEDUREmyocardial biopsy

Myocardial cell edema either focal or diffuse was detected in histopathological examination

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Intervention model description

Myocardial cell edema either focal or diffuse was detected in histopathological examination in pediatric patients undergoing total repair of Tetrology of Fallout

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.
Serum cardiac troponin level	first 24 hours	Samples for troponin I levels at baseline, 6, 12 and 24 hours after aortic cross-clamping.
30-day mortality	30 days	number of patients died
Type of cardiac rhythm on return	within 24 hours	Type of cardiac rhythm on return

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026