Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

Myocardial Perfusion Echocardiography to Detect Human Heart Transplant

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.

Study Overview

• Status: Terminated
• Conditions: Heart Transplantation
• Intervention / Treatment: Drug: Optison

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

• Study Contact: Name: Michael Givertz, MD; Phone Number: 617-525-7052
• Study Contact Backup: Name: Reza Abdi, MD; Phone Number: 617-732-7249

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Heart Transplant patients

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart Transplant Rejection; Patients presenting with acute cellular rejection	Drug: Optison; Echocardiogram with IV contrast; Other Names: Echocontrast agent
Heart Transplant Control; Patients presenting for routine office visit	Drug: Optison; Echocardiogram with IV contrast; Other Names: Echocontrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global and regional microvascular myocardial perfusion	Myocardial blood flow (dB/s)	Baseline

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: General Electric
• Investigators: Principal Investigator: Michael Givertz, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimated): November 25, 2014

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Acute rejection, myocardial blood flow
• Other Study ID Numbers: BWHMG370000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO