Intraoperative Echocardiography in Low-Risk CABG Surgery

NCT06154265 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 853364
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This goal of this study is to better understand when and where intraoperative transesophageal echocardiography (TEE) should (or should not) be used during coronary artery bypass graft (CABG) surgeries.

Conditions

Heart Diseases; Coronary Artery Disease; Chest Pain; Stenosis Coronary; STEMI

Keywords

Heart; Chest Pain; Artery; Stenosis; TEE; CABG; Bypass

Outcome Measures

Primary Outcomes (1)

• Primary Objectives

  1. Recruitment feasibility assessment as measured by an absolute recruitment rate. Absolute recruitment rate is defined as the number of successfully enrolled participants divided by the total number of screened participants. 2. Assess intervention fidelity by calculating the rate of TEE performed among participants randomized to the as-needed TEE trial arm.

  24 months

Secondary Outcomes (1)

• Secondary Objectives

  24 month

Study Arms (2)

Default TEE

ACTIVE COMPARATOR

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.

Device: TEE probe

As-needed TEE

OTHER

The TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.

Device: TEE probe

Interventions

TEE probe DEVICE

Transesophageal echocardiography, ultrasound probe

Also known as: Philips transesophageal echocardiography (TEE), ultrasound probe

As-needed TEE; Default TEE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo isolated CABG surgery at a hospital within the UPenn Health System
• Age ≥18 years
• Ejection fraction ≥50%
• Transthoracic echocardiography within one year of scheduled surgery date
• Left heart catheterization within one year of scheduled surgery date
• English language fluency or facilitated via language interpreter
• Able to provide informed consent either in English or via a language interpreter
• Willing to comply with all study procedures

You may not qualify if:

• 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. plan for either definite or possible surgical intervention.
• Any CABG surgery with either "possible" or "definite" valve repair/replacement listed as a planned part of the procedure.
• Having undergone any previous cardiac surgeries (i.e. scheduled with a "REDO" modifier).
• Proximal/critical left main coronary disease (e.g. greater than or equal to 90% stenosis).
• Preexisting anomalous coronary arteries
• Preexisting end-stage renal disease on hemodialysis
• Preexisting chronic kidney disease (CKD) stage 3, 4, or 5
• Stroke with residual focal neurological deficit(s) within 90 days of surgery
• Any of the following presurgical, mechanical circulatory support devices:
• Intraaortic balloon pump
• Percutaneous right ventricular assist device (RVAD)
• Impella
• Extracorporeal membrane oxygenation (ECMO)
• Absolute contraindication to echocardiography defined as one or more of the following documented conditions:

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease; Chest Pain; Coronary Stenosis; ST Elevation Myocardial Infarction; Constriction, Pathologic

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Emily MacKay, DO, MS

  University of Pennsylvania, Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: (1) Default TEE: Where the TEE probe is placed after going under general anesthesia and a breathing tube is placed. TEE issued to take pictures of your heart before and after the CABG surgery. The TEE probe will remain in place throughout the surgery. (2) As-Needed TEE: Where the TEE probe is placed only in situations where a surgeon requires information that can only be obtained by ultrasound imaging of the heart.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: December 4, 2023
• Study Start: January 22, 2024
• Primary Completion: March 15, 2025
• Study Completion: December 31, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

US (1)