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Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02300870
Collaborator
General Electric (Industry)
40
Enrollment
1
Location
59
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Myocardial Perfusion Echocardiography to Detect Human Heart Transplant
Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Global and regional microvascular myocardial perfusion [Baseline]

      Myocardial blood flow (dB/s)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • General Electric

    Investigators

    • Principal Investigator: Michael Givertz, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Givertz, MD, Medical Director, Heart Transplant and Mechanical Circulatory Support, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT02300870
    Other Study ID Numbers:
    • BWHMG370000
    First Posted:
    Nov 25, 2014
    Last Update Posted:
    Feb 1, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Michael Givertz, MD, Medical Director, Heart Transplant and Mechanical Circulatory Support, Brigham and Women's Hospital
    Acute rejection, myocardial blood flow

    Study Results

    No Results Posted as of Feb 1, 2018