Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Transplantation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Transplant Rejection

Patients presenting with acute cellular rejection

Optison

Intervention Type DRUG

Echocardiogram with IV contrast

Heart Transplant Control

Patients presenting for routine office visit

Optison

Intervention Type DRUG

Echocardiogram with IV contrast

Interventions

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Optison

Echocardiogram with IV contrast

Intervention Type DRUG

Other Intervention Names

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Echocontrast agent

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No