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
• Status: Terminated
• 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
• 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)

Related Conditions & MeSH terms

• Heart Transplantation

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