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临床试验/NCT03149341
NCT03149341Enrolling By Invitation不适用

MR Imaging and Computational Simulation of Cardiovascular Physiology Including Velocity, Pressure, and Wall Shear Stress

Stanford University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2008年2月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
75
试验地点
1
主要终点
Wall Shear Stress

研究概览

简要总结

The purpose of this study is to (1) quantify cardiovascular anatomy and physiology using magnetic resonance imaging under both resting and exercise conditions in patients who have congenital heart disease and in age-matched normal volunteers, (2) use computer models to reproduce and simulate blood flow in these patients, and then (3) to combine the imaging data and computer models to estimate values which cannot be directly measured and to predict physiological changes induced by exercise and medical or surgical therapies.

详细描述

Investigators hope to gain a greater understanding of the hemodynamics of congenital heart disease and their associated operations as they pertain to real-life situations (i.e. upright and non-sedentary, rest and exercise). With this knowledge, investigators would look to optimize the geometry and physiology of the patients, potentially reducing several of the long-term complications found in congenital heart disease patients such as cardiomyopathy, pulmonary hypertension, arrhythmias, thrombosis and heart failure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • patients will have congenital heart disease or acquired cardiopulmonary disease.
  • normal volunteers will be willing to undergo MRI

排除标准

  • patients unable to receive intravenous contrast material (this does not apply to normal volunteers)
  • subjects with arrhythmias which will prevent MRI cardiac gating
  • subjects with illnesses which make participation inappropriate. In addition, patients who would normally be excluded from an MRI study because of pacemaker implant, aneurysm clip, severe claustrophobia, or any other condition which, based on the Investigator's judgment, would preclude proximity to a strong magnetic field will be excluded from this study as well.
  • NORMAL VOLUNTEERS may be excluded if they are not able to remain still during the exam or follow the instructions of the investigators.

结局指标

主要结局

Wall Shear Stress

时间窗: 20 years

Computational parameters derived from clinical diagnostic modalities

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey A. Feinstein

MD, MPH. Associate Professor, Pediatrics and, by courtesy, BioEngineering. Director, Pediatric Cardiology Fellowship Program. Director, Vera Moulton Wall Center for Pulmonary Vascular Disease

Stanford University

研究点 (1)

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