Skip to main content
OpenTrials
Completed

NCT Number: NCT04194502

Coronary Artery Assessement by TEE in Congenital Heart Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Transesophageal echocardiogram (TEE)

Diagnostic Test

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

Primary outcomes

  1. Coronary artery pulse doppler flow patterns will be assessed as normal or abnormal in patients with congenital heart disease

    Time frame: 5-7 minutes per TEE

    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

  2. Measure the coronary artery pulse doppler flow velocities (cm/sec) in patients with congenital heart disease

    Time frame: 5-7 minutes per TEE

    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.

  3. Correlate pre-operative and post-operative coronary artery flow patterns abnormal and velocities (cm/sec) with negative post-operative clinical outcomes

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 11, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.