Myocardial Biopsy in Congenital Cardiac Surgery

Myocardial Protection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03595111
• Other study ID #: IRB00008715964
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2018
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myocardial Protection

Intervention

Procedure:
• myocardial biopsy
Myocardial cell edema either focal or diffuse was detected in histopathological examination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial biopsy	Myocardial cell edema either focal or diffuse was detected in histopathological examination	within 24 hours
Secondary	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
Secondary	Serum cardiac troponin level	Samples for troponin I levels at baseline, 6, 12 and 24 hours after aortic cross-clamping.	first 24 hours
Secondary	30-day mortality	number of patients died	30 days
Secondary	Type of cardiac rhythm on return	Type of cardiac rhythm on return	within 24 hours