Coronary Artery Assessement by TEE in Congenital Heart Disease
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transesophageal echocardiogram (TEE)
Sponsored by
About this trial
This is an interventional other trial for Congenital Heart Disease focused on measuring Transesophageal echocardiography
Eligibility Criteria
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
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pre-operative and intra-operative TEE
Arm Description
All patients enrolled in the study will undergo a pre-op research TEE and a intra-op clinical transesophageal echo.
Outcomes
Primary Outcome Measures
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
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04194502
First Posted
November 12, 2019
Last Updated
December 10, 2019
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT04194502
Brief Title
Coronary Artery Assessement by TEE in Congenital Heart Disease
Official Title
Intraoperative Coronary Artery Flow Patterns in Patients With Congenital Heart Disease and the Relationship to Short Term Surgical Outcomes.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
June 18, 2018 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Transesophageal echocardiography
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-operative and intra-operative TEE
Arm Type
Other
Arm Description
All patients enrolled in the study will undergo a pre-op research TEE and a intra-op clinical transesophageal echo.
Intervention Type
Diagnostic Test
Intervention Name(s)
Transesophageal echocardiogram (TEE)
Intervention Description
All patients enrolled in the study will undergo a pre-operative research TEE and an intra-operative clinical TEE.
Primary Outcome Measure Information:
Title
Coronary artery pulse doppler flow patterns will be assessed as normal or abnormal in patients with congenital heart disease
Description
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
Time Frame
5-7 minutes per TEE
Title
Measure the coronary artery pulse doppler flow velocities (cm/sec) in patients with congenital heart disease
Description
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.
Time Frame
5-7 minutes per TEE
Title
Correlate pre-operative and post-operative coronary artery flow patterns abnormal and velocities (cm/sec) with negative post-operative clinical outcomes
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynne Nield, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Coronary Artery Assessement by TEE in Congenital Heart Disease
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