Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

Mass General Brigham

Status: Terminated

Conditions: Heart Transplantation

Treatments: Drug: Optison

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02300870

BWHMG370000

Details and patient eligibility

About

The primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital

Exclusion criteria

• hemodynamic instability (e.g., systolic blood pressure < 90 mmHg)
• atrial fibrillation with rapid ventricular response (e.g., heart rate > 120 bpm)
• premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment
• poor acoustic windows
• inability to provide informed consent
• any contraindication listed in the Optison package insert (i.e., history of an allergic reaction)

Trial design

10 participants in 2 patient groups

Heart Transplant Rejection

Description:

Patients presenting with acute cellular rejection

Treatment:

Drug: Optison

Heart Transplant Control

Description:

Patients presenting for routine office visit

Treatment:

Drug: Optison