Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Myocardial Ischemia measuring coronary perfusion reserve.
研究概览
简要总结
This is a study of the perfusion of the myocardium in adults with specific forms of repaired congenital heart disease using established cardiac MRI techniques and correlating perfusion with clinical outcomes.
详细描述
This is a study of the perfusion of the myocardium in adults with specific forms of repaired congenital heart disease using established cardiac MRI techniques and correlating perfusion with clinical outcomes. The investigators objectives are to examine myocardial perfusion both during stress and at rest in adults with repaired or palliated congenital heart disease as well as quantify ventricular function, regional myocardial strain and evidence of myocardial fibrosis with quantitative measures of myocardial perfusion. The specific aim of this study is to understand whether clinical subendocardial perfusion defects contribute to the late decompensation of adult subjects that have single ventricle physiology and adult subjects that have a systemic right ventricle.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years of age or older
- •All defects that have a right ventricle that supports the systemic circulation
- •All defects with a functional single ventricle
- •Written informed consent
排除标准
- •Subjects with a contraindication to magnetic resonance imaging (MRI) scanning will be excluded. These contraindications include subjects with the following devices:
- •Central nervous system aneurysm clips
- •Implanted neural stimulator
- •Implanted cardiac pacemaker or defibrillator
- •Cochlear implant
- •Ocular foreign body (e.g. metal shavings)
- •Implanted Insulin pump
- •Metal shrapnel or bullet
- •Severe heart damage that makes it difficult to breathe while lying flat
- •Pregnant women (Women of childbearing potential who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test)
- •Subjects with active symptoms of myocardial ischemia occurring despite maximally tolerated doses of oral antianginal therapy and intravenous nitroglycerin
- •Furthermore, the following subject groups will be excluded from studies involving the administration of MRI contrast agents:
- •lactating women unless they are willing to discard breast milk for 24 hours after receiving gadolinium
- •renal disease (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73 m2 body surface area)
- •The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to subjects with acute renal insufficiency:
- •eGFR (ml/min/1.73 m2) = 175 x (serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) x 1.212 (if the subject is black)
- •Additional Exclusion Criteria for Vasodilator Stress MRI:
- •Myocardial infarction within 24 hours
- •Uncontrolled heart failure
- •Uncontrolled asthma or emphysema
- •Ventricular arrhythmia (sustained ventricular arrhythmia at the time of MR scan)
- •Second degree heart block or higher
结局指标
主要结局
Myocardial Ischemia measuring coronary perfusion reserve.
时间窗: 5 years
Compare quantitative myocardial perfusion at stress and rest with measures of systolic and diastolic function in exams performed in close temporal proximity.
Myocardial Ischemia measuring ejection fraction.
时间窗: 5 years
Compare the extent of myocardial ischemia through ejection fraction measurement of the systemic ventricle.
Myocardial Ischemia measuring heart inflow Doppler.
时间窗: 5 years
Compare heart inflow Doppler of the systemic atrioventricular valve to understand the extent of myocardial ischemia.
次要结局
- Scarring and fibrosis by measuring Late Gadolinium Enhancement results.(5 years)
- Scarring and fibrosis by measuring systolic and diastolic function.(5 years)
- Comparison of MRI measurements with blood test.(5 years)
- Comparison of MRI measurements with walk test.(5 years)
- Comparison of MRI measurements with NY Heart Association class(5 years)
研究者
Laura Olivieri
MD
Children's National Research Institute