Coronary Artery Assessement by TEE in Congenital Heart Disease

NCT04194502 | Completed

• 1 other identifier: 1000056046
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease

Keywords

Transesophageal echocardiography

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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)

Study Arms (1)

Pre-operative and intra-operative TEE

OTHER

All patients enrolled in the study will undergo a pre-op research TEE and a intra-op clinical transesophageal echo.

Diagnostic Test: Transesophageal echocardiogram (TEE)

Interventions

Transesophageal echocardiogram (TEE) DIAGNOSTIC_TEST

All patients enrolled in the study will undergo a pre-operative research TEE and an intra-operative clinical TEE.

Pre-operative and intra-operative TEE

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with hypoplastic left heart syndrome undergoing Norwood operation or Hybrid procedure
• Patients who have undergone heart transplantation.
• Patients were transoespphageal echocardiography is contraindicated (less than 3kg, recent upper gastrointestinal surgery).
• Operations where TEE is not routinely indicated (patent ductus arteriosus ligation, aortic coarctation repair via a thoracotomy, vascular ring ligations).
• Patients whose primary reason for surgery is coronary artery stenosis

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Lynne Nield, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Model Details: The purpose of the study 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

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 11, 2019
• Study Start: April 19, 2017
• Primary Completion: June 18, 2018
• Study Completion: July 31, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)