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NCT02300870 Clinical Trial

Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection

Heart Transplantation Clinical Trial

Official title:
Myocardial Perfusion Echocardiography to Detect Human Heart Transplant

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02300870
Other study ID # BWHMG370000
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 2015
Est. completion date December 2019

Study information
Verified date July 2023
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Optison
Echocardiogram with IV contrast

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Brigham and Women's Hospital General Electric

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Global and regional microvascular myocardial perfusion Myocardial blood flow (dB/s) Baseline
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