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Coronary Artery Assessement by TEE in Congenital Heart Disease

NCT ID: NCT04194502

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Congenital Heart Disease

Keywords

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Transesophageal echocardiography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Pre-operative and intra-operative TEE

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

Group Type OTHER

Transesophageal echocardiogram (TEE)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Transesophageal echocardiogram (TEE)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Lynne Nield

Staff Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lynne Nield, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000056046

Identifier Type: -

Identifier Source: org_study_id