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Clinical Trials/NCT02300870
NCT02300870
Terminated
N/A

Myocardial Perfusion Echocardiography to Detect Human Heart Transplant

Brigham and Women's Hospital1 site in 1 country10 target enrollmentJanuary 2015
InterventionsOptison
DrugsOptison

Overview

Phase
N/A
Intervention
Optison
Conditions
Heart Transplantation
Sponsor
Brigham and Women's Hospital
Enrollment
10
Locations
1
Primary Endpoint
Global and regional microvascular myocardial perfusion
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2019
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Givertz, MD

Medical Director, Heart Transplant and Mechanical Circulatory Support

Brigham and Women's Hospital

Eligibility Criteria

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)

Arms & Interventions

Heart Transplant Rejection

Patients presenting with acute cellular rejection

Intervention: Optison

Heart Transplant Control

Patients presenting for routine office visit

Intervention: Optison

Outcomes

Primary Outcomes

Global and regional microvascular myocardial perfusion

Time Frame: Baseline

Myocardial blood flow (dB/s)

Study Sites (1)

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