NCT02300870

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

4.9 years

First QC Date

November 17, 2014

Last Update Submit

July 26, 2023

Conditions

Heart Transplantation

Keywords

Acute rejection, myocardial blood flow

Outcome Measures

Primary Outcomes (1)

  • Global and regional microvascular myocardial perfusion

    Myocardial blood flow (dB/s)

    Baseline

Study Arms (2)

Heart Transplant Rejection

Patients presenting with acute cellular rejection

Drug: Optison

Heart Transplant Control

Patients presenting for routine office visit

Drug: Optison

Interventions

OptisonDRUG

Echocardiogram with IV contrast

Also known as: Echocontrast agent
Heart Transplant ControlHeart Transplant Rejection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart Transplant patients

You may qualify if:

  • All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

FS 069

Study Officials

  • Michael Givertz, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Heart Transplant and Mechanical Circulatory Support

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 25, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)