Congenital Heart DiseaseNCT04194502
Coronary Artery Assessement by TEE in Congenital Heart Disease
A study testing Transesophageal echocardiogram (TEE) in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Transesophageal echocardiogram (TEE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteCanada
- Study dates
- 19 Apr 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients undergoing surgical repair of congenital heart lesions at the Hospital for Sick Children between May 2017 and May 2018.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Coronary Artery Flow Patterns in Patients With Congenital Heart Disease and the Relationship to Short Term Surgical Outcomes.
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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Transesophageal echocardiogram (TEE)
- Keywords
- Transesophageal echocardiography
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal echocardiogram (TEE)Diagnostic test
All patients enrolled in the study will undergo a pre-operative research TEE and an intra-operative clinical TEE.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Transesophageal echocardiogram (TEE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start19 Apr 2017
- Primary completion18 Jun 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynne Nield, The Hospital for Sick Children
- Investigators
- Lynne Nield, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194502
- Sponsor's protocol ID
- 1000056046
- Status last verified
- Dec 2019
- First submitted
- 12 Nov 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Coronary Artery Flow Patterns in Patients With Congenital Heart Disease and the Relationship to Short Term Surgical Outcomes.
- ClinicalTrials.gov ID
- NCT04194502
- Acronym / sponsor ID
- 1000056046
- Conditions
- Congenital Heart Disease
- Keywords
- Transesophageal echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Pre-operative and intra-operative TEE | Other | Diagnostic Test: Transesophageal echocardiogram (TEE)All patients enrolled in the study will undergo a pre-op research TEE and a intra-op clinical transesophageal echo. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients undergoing surgical repair of congenital heart lesions at the Hospital for Sick Children between May 2017 and May 2018.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echocardiogram (TEE)All patients enrolled in the study will undergo a pre-operative research TEE and an intra-operative clinical TEE. | Diagnostic test | Pre-operative and intra-operative TEE |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne Nield, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transesophageal echocardiogram (TEE) in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.