Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300870
Recruitment Status : Recruiting
First Posted : November 25, 2014
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Michael Givertz, MD, Brigham and Women's Hospital

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
Heart Transplantation Drug: Optison

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Myocardial Perfusion Echocardiography to Detect Human Heart Transplant
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Heart Transplant Rejection
Patients presenting with acute cellular rejection
Drug: Optison
Echocardiogram with IV contrast
Other Name: Echocontrast agent

Heart Transplant Control
Patients presenting for routine office visit
Drug: Optison
Echocardiogram with IV contrast
Other Name: Echocontrast agent




Primary Outcome Measures :
  1. Global and regional microvascular myocardial perfusion [ Time Frame: Baseline ]
    Myocardial blood flow (dB/s)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart Transplant patients
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300870


Contacts
Layout table for location contacts
Contact: Michael Givertz, MD 617-525-7052
Contact: Reza Abdi, MD 617-732-7249

Locations
Layout table for location information
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michael M Givertz, MD    617-525-7052    mgivertz@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
General Electric
Investigators
Layout table for investigator information
Principal Investigator: Michael Givertz, MD Brigham and Women's Hospital

Layout table for additonal information
Responsible Party: Michael Givertz, MD, Medical Director, Heart Transplant and Mechanical Circulatory Support, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02300870     History of Changes
Other Study ID Numbers: BWHMG370000
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Givertz, MD, Brigham and Women's Hospital:
Acute rejection, myocardial blood flow