Intraoperative Echocardiography in Low-Risk CABG Surgery

NCT06154265 | Completed Results 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)

• Enrollment and Randomization Feasibility

  Enrollment and randomization feasibility defined as the proportion of patients approached for enrollment who consented and were successfully randomized. Of 72 patients approached for enrollment, 40 were randomized.

  At time of enrollment and randomization (baseline)

Secondary Outcomes (2)

• Protocol Adherence

  During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)

• Rescue Echocardiography Use in the Backup TEE Arm

  During index surgical procedure (from induction of anesthesia to completion of surgery; typical duration approximately 5-8 hours)

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

Limitations and Caveats

This two-hospital feasibility trial was not powered to detect differences in clinical outcomes. The small sample size and limited follow-up preclude conclusions regarding the safety or effectiveness of either arm. Findings are intended to inform the design and conduct of a larger multicenter trial. The term "Backup TEE" used in this record corresponds to the "As-needed TEE" strategy described in the IRB-approved protocol and the "TEE-on-Demand" strategy used in the manuscript.

Results Point of Contact

• Title: Emily J. MacKay DO, MS, Assistant Professor of Anesthesiology
• Organization: University of Pennsylvania

emily.mackay@pennmedicine.upenn.edu

(215) 662-3751

Study Officials

• Emily MacKay, DO, MS

  University of Pennsylvania, Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: March 15, 2026
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-04

Locations

US (1)