Clinical trial NCT02880137: Real Time Myocardial Perfusion Echocardiography for Coronary Allograft Vasculopathy
Official title: (RTMPE for CAV) Real Time Myocardial Perfusion Echocardiography for Detection of Coronary Allograft Vasculopathy in Cardiac Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Allograft Vasculopathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2016-08-26
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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?

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Number of Subjects With a Perfusion Defect
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jonathan N Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: