Cardiac MRI Increases Accuracy and Decreases Risk of Evaluation of Children with Cardiomyopathy and Cardiac Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlate MRI imaging results to biopsy results Correlate MRI imaging with endomyocardial biopsy
研究概览
简要总结
Overall Research Strategy of this protocol is to refine and validate noninvasive CMR imaging sequences with invasive hemodynamic and pathology results to create a comprehensive, noninvasive, radiation-reduced regimen for pediatric cardiomyopathy and cardiac transplant assessment. We were the first to perform MR-guided cardiac catheterization in US children, and have accumulated the largest US experience, having performed over 75 procedures to date. Our unique experience puts us in strong position to leverage this technology to improve care of children with cardiomyopathy and transplant. Using an integrated approach, we will simultaneously (1) validate imaging measures of cardiac edema and fibrosis by correlating T1 and T2 map images with endomyocardial biopsy (EMB) results in Aim 1; (2) overlay T1, T2 map images into our x-ray system to display "hotspots" of T1 and T2 abnormalities to guide EMB in Aim 2; and (3) obtain radiation-free hemodynamic data in a highly vulnerable pediatric population by using CMR to guide catheter manipulation in the ICMR suite in Aim 3.
Age and diagnosis-matched historical controls will be identified from the last 10 years at Children's National as a control population for specific purposes of comparing (1) EMB yield without image overlay and (2) Radiation exposure during X-ray guided right heart catheterization. Identical information will be obtained and stored in the same 45CFR compliant database. Historical controls will be identified from the cardiac catheterization database by searching for age and diagnosis. A waiver of consent will be applicable here, as it would be inconvenient, insensitive and not feasible to consent families who have already undergone treatment.
详细描述
Anesthesia and Vascular Access After final review of protocol eligibility and of MRI safety, vascular access is obtained and sheaths are secured and covered with a sterile drape for transfer to the MRI. The catheterization is performed with continuous recording of electrocardiogram signals, transcutaneous hemoglobin ("pulse") oximetry, and under direct observation of an anesthesia licensed independent provider.
Diagnostic Cardiac MRI Before MRI catheterization begins, a focused cardiac MRI is performed to understand cardiac function and localize the proposed catheter trajectory from the access site into the targeted cardiovascular chambers.
MRI-guided catheterization Next during real-time MRI, a passive catheter is advanced from the access site into the targeted cardiovascular chambers under imaging guidance. Hemodynamic measurements (using fluid-filled transducers connected to the catheters) and blood hemoglobin saturation specimens are obtained from targeted cardiovascular chambers. Additional clinically-indicated and, if time allows, up to 30 minutes of research MRI is then performed before the subject is returned to the X-ray system.
Research MR Imaging Additional research cardiac MRI imaging to determine T1 and T2 values is undertaken next, with 6 short axis slices and one long axis slice positions identified for T1 map and T2 map acquisitions. The ICMR laboratory has a robust experience with acquisition of parametric mapping sequences. T1 and T2 maps will provide a roadmap for the cardiac biopsy that the patient requires in the xray suite.
Image Fusion to Guide Endomyocardial Biopsy At the conclusion of the MR imaging and MR-guided right heart catheterization procedure, the subject is returned to the X-ray suite for cardiac biopsy. Some cardiac biopsies are obtained in the usual fashion, and some biopsy specimens are obtained using image overlay software to display the regions of abnormal T1 and T2 onto the fluoroscopy system.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adults of any age with heart transplant, suspected or confirmed cardiomyopathy
- •Undergoing clinically-indicated ("medically necessary") cardiovascular catheterization
排除标准
- •Cardiovascular instability including hemodynamic instability (such as requiring significant vasoactive infusion support) or mechanical hemodynamic support.
- •Women who are pregnant
- •Women who are nursing and who do not plan to discard breast milk for 24 hours
- •Exclusion criteria for MRI
- •Central nervous system aneurysm clips
- •Implanted neural stimulator
- •Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
- •Cochlear implant
- •Ocular foreign body (e.g. metal shavings)
- •Implanted Insulin pump
- •Metal shrapnel or bullet.
- •Exclusion criteria for Gadolinium
- •Renal disease with 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.
- •The Schwartz equation 33 for estimation of GFR in children as recommended by the NKDEP is as follows:
- •GFR (mL/min/1.73 m2) = (k × height) / serum creatinine concentration
- •where k = constant defined as follows: k = 0.33 in premature infants k = 0.45 in term infants to 1 year of age k = 0.55 in children to 13 years of age k = 0.70 in adolescent males (not females because of the presumed increase in male muscle mass, the constant remains 0.55 for females) Height in cm Serum creatinine in mg/dL
结局指标
主要结局
Correlate MRI imaging results to biopsy results Correlate MRI imaging with endomyocardial biopsy
时间窗: At the end of each catheterization procedure through study completion,up to 5 years
Correlate MRI imaging sequences that can detect inflammation and fibrosis to quantities of inflammation and fibrosis seen on biopsy specimens taken from the same region.
次要结局
- Compare yield of biopsy specimen collection using x-ray vs x-ray fused MRI images(At the end of each catheterization procedure through study completion,up to 5 years)
- Radiation exposure(At the end of each catheterization procedure through study completion,up to 5 years)
研究者
Laura Olivieri
Associate Professor of Pediatrics/Cardiologist
University of Pittsburgh