跳至主要内容
临床试验/NCT02880137
NCT02880137已完成4 期

(RTMPE for CAV) Real Time Myocardial Perfusion Echocardiography for Detection of Coronary Allograft Vasculopathy in Cardiac Transplant Patients

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Mayo Clinic
入组人数
36
试验地点
1
主要终点
Number of Subjects With a Perfusion Defect

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

RTMPE

Experimental

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.

干预措施: Perflutren Lipid Microsphere (Drug)

RTMPE

Experimental

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.

干预措施: RTMPE (Procedure)

结局指标

主要结局

Number of Subjects With a Perfusion Defect

时间窗: baseline

A perfusion defect will first be identified using clinically indicated invasive coronary angiography (ICA). The presence of a perfusion defect will then be identified using non-invasive real time myocardial perfusion echocardiography (RTMPE).

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan N. Johnson, M.D.

Principal Investigator

Mayo Clinic

研究点 (1)

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