Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Cardiac Allograft Vasculopathy

Treatments: Drug: Perflutren Lipid Microsphere; Procedure: RTMPE

Study type: Interventional

Funder types: Other

Identifiers

NCT02880137

15-007825

Details and patient eligibility

About

Is real-time myocardial perfusion echocardiography (RTMPE) a feasible and effective non-invasive method to detect significant Coronary Allograft Vasculopathy in pediatric and adult cardiac transplant recipients? Will perfusion deficits correlate with significant coronary artery stenosis identified by standard stress echocardiography and Invasive Coronary Angiography (ICA), and identify diffuse small vessel disease more effectively than current non-invasive techniques?

Full description

Heart transplant recipients are susceptible to developing a unique disease that causes blockages in the arteries of the transplanted heart (coronary arteries) called Coronary Allograft Vasculopathy (CAV). Because CAV often progresses without symptoms, transplant recipients undergo regular surveillance testing so that CAV can be detected and treatment can be offered before significant damage to the transplanted heart occurs. Current tests used to detect CAV are either invasive (with risk of complications) or may not be able to detect CAV in its early stages. Myocardial contrast perfusion echocardiography is a safe non-invasive diagnostic test that may be well suited for detecting CAV, however has not been well studied in heart transplant recipients. This study examines the ability of myocardial contrast perfusion echocardiography to detect CAV in adult and pediatric heart transplant recipients, and compare those results to current standard testing strategies such as Invasive Coronary Angiography (ICA) and standard stress echocardiography. This will help determine whether myocardial contrast perfusion echocardiography is a better test for regular surveillance of CAV in adult and pediatric transplant recipients.

Enrollment: 36 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Cardiac transplant recipients (> or equal to 10 months post transplant)
• Clinically followed at Mayo Clinic, Rochester Minnesota

Exclusion:

• Standard contraindications to the use of ultrasound contrast and pharmacologic stress
• Recent (< 3 months) hospitalization for heart failure, acute coronary syndrome or allograft rejection
• Multi-organ transplant Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
• Hypersensitivity to perflutren

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

RTMPE

Experimental group

Description:

RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.

Treatment:

Procedure: RTMPE

Drug: Perflutren Lipid Microsphere