Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection
- Registration Number
- NCT02300870
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Heart Transplant Control Optison Patients presenting for routine office visit Heart Transplant Rejection Optison Patients presenting with acute cellular rejection
- Primary Outcome Measures
Name Time Method Global and regional microvascular myocardial perfusion Baseline Myocardial blood flow (dB/s)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States