Coronary Artery Assessement by TEE in Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:

Intraoperative Coronary Artery Flow Patterns in Patients With Congenital Heart Disease and the Relationship to Short Term Surgical Outcomes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194502
• Other study ID #: 1000056046
• Status: Completed
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: December 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to establish normal coronary artery pulse Doppler flow patterns and velocities using transoesophageal echocardiography (TEE) in patients with a variety of congenital heart disease. This will be accomplished by performing pre-operative and intra-operative TEEs on up to 250 patients undergoing surgery for congenital heart disease.

Description:

Little is known about coronary artery flow patterns in children. Invasive and non invasive studies in normal children have demonstrated that coronary artery flow velocities decrease with age and therefore heart rate. 'Normal' flow velocities in the left coronary artery are usually accepted between 0.3-0.6m/sec depending on age of the patient. Less is known about coronary flow patterns and velocities in patients with congenital heart disease. In addition the effects of coronary artery bypass and altered loading conditions may affect coronary flow patterns and velocities and in theory alter short and long term outcomes. This study hopes to is to establish normal coronary artery pulse Doppler flow patterns and velocities using transoesophageal echocardiography (TEE) in patients with a variety of congenital heart disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 31, 2019
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• All patients undergoing surgical repair of congenital heart lesions at the Hospital for Sick Children between May 2017 and May 2018.

Exclusion Criteria:

1. Patients with hypoplastic left heart syndrome undergoing Norwood operation or Hybrid procedure

2. Patients who have undergone heart transplantation.

3. Patients were transoespphageal echocardiography is contraindicated (less than 3kg, recent upper gastrointestinal surgery).

4. Operations where TEE is not routinely indicated (patent ductus arteriosus ligation, aortic coarctation repair via a thoracotomy, vascular ring ligations).

5. Patients whose primary reason for surgery is coronary artery stenosis

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Diagnostic Test:
• Transesophageal echocardiogram (TEE)
All patients enrolled in the study will undergo a pre-operative research TEE and an intra-operative clinical TEE.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary artery pulse doppler flow patterns will be assessed as normal or abnormal in patients with congenital heart disease	Pulse Doppler flow patterns in the LMCA, LAD, circumflex and RCA will be assessed as normal or abnormal using transoesophageal echocardiography (TEE) in patients with a variety of congenital heart disease	5-7 minutes per TEE
Primary	Measure the coronary artery pulse doppler flow velocities (cm/sec) in patients with congenital heart disease	The coronary artery pulse Doppler diastolic and systolic flow velocities (cm/sec) of the LMCA, LAD, circumflex and RCA will be assessed using TEE in patients with a variety of congenital heart disease.	5-7 minutes per TEE
Primary	Correlate pre-operative and post-operative coronary artery flow patterns abnormal and velocities (cm/sec) with negative post-operative clinical outcomes	Determine if there is a relationship between abnormal coronary artery flow patterns and velocities with negative post-operative clinical outcomes including death, delayed sternal closure, ECMO, ST segment changes, ventricular fibrillation or tachycardia, need for catheterization and stroke.	Post-operative events will be collected from the time of discharge from the operating room until the participant is discharged from the hospital (typically between 3-14 days)