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Intraoperative Echocardiography for Heart Disease
N/A
Waitlist Available
Led By Emily MacKay, DO, MS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Scheduled to undergo isolated CABG surgery at PPMC
Must not have
Documented valve (aortic, mitral, tricuspid, or pulmonic) disease (stenosis or regurgitation) moderate or greater
Any CABG surgery with either 'possible' or 'definite' aortic intervention listed as a planned part of the procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 month
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine which CABG patients need TEE during surgery to improve outcomes.
Who is the study for?
This trial is for adults over 18 who are scheduled for low-risk isolated CABG surgery, have a good heart pump function (ejection fraction ≥50%), and recent heart tests. It's not for those with moderate or severe valve disease, planned aortic interventions, critical coronary disease, end-stage kidney disease on dialysis, certain esophageal conditions, or severe pulmonary hypertension.
What is being tested?
The study aims to determine the usefulness of using an intraoperative TEE probe during CABG surgeries. The TEE probe is used to take detailed images of the heart from inside the esophagus during surgery to guide decisions and improve outcomes.
What are the potential side effects?
While not explicitly stated in this summary, potential side effects of using a TEE probe may include sore throat, difficulty swallowing or rare complications like esophageal injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am scheduled for a heart bypass surgery at PPMC.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have moderate or severe heart valve disease.
Select...
I am scheduled for CABG surgery that may include work on my aorta.
Select...
I have had severe heart or blood pressure issues after a specific medical procedure.
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I cannot have an echocardiogram due to past esophageal surgery or injury.
Select...
I have severe narrowing in my heart's main artery.
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I am on hemodialysis for end-stage kidney disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Objectives
Secondary study objectives
Secondary Objectives
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: As-needed TEEExperimental Treatment1 Intervention
The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.
Group II: Default TEEActive Control1 Intervention
The TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of the heart before and after a CABG surgery. If randomized to this group, the TEE probe will remain in place throughout the surgery.
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,072 Previous Clinical Trials
42,713,946 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,810 Previous Clinical Trials
8,159,592 Total Patients Enrolled
Emily MacKay, DO, MSPrincipal InvestigatorUniversity of Pennsylvania, Penn Medicine
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