Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04194502
Status:
COMPLETED
Last Update Posted:
2019-12-11
First Post:
2019-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coronary Artery Assessement by TEE in Congenital Heart Disease
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
Intraoperative Coronary Artery Flow Patterns in Patients With Congenital Heart Disease and the Relationship to Short Term Surgical Outcomes.
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: