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临床试验/NCT02550366
NCT02550366终止不适用

Novel Accelerated Contrast-Enhanced High Resolution Whole Heart Cardiac MR for Non-Invasive Evaluation of Coronary Artery Disease

University of Minnesota1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
44
试验地点
1
主要终点
left and right ventricular volumes and masses,

研究概览

简要总结

Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac MRI is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be used in the diagnosis of CAD. In this work, the investigators will develop and validate techniques for accelerated cardiac MRI, offering better volumetric coverage of the heart, improved contrast, and superior spatial and temporal resolutions.

详细描述

Coronary artery disease (CAD) is the leading cause of death in the United States, even though significant efforts have been made in prevention and diagnosis. The clinical gold standard for diagnosis of CAD is catheter-based invasive x-ray angiography, performed more than a million times per year. Of these examinations, up to 35% have been found to have no significant stenosis, yet these patients had to go through the potential risks and complications of an invasive test that further exposes the patient to ionizing radiation and iodinated contrast. Thus, non-invasive diagnostic alternatives are highly desirable.

Cardiac MRI (CMR) provides a method for a comprehensive non-invasive cardiac exam, including contractile functional assessment (cine) to detect wall-motion abnormality, myocardial CMR perfusion for diagnosing perfusion defects, viability assessment using late gadolinium enhancement for evaluation of acute and chronic myocardial infarction, and coronary MRI for the identification of stenosis. CMR is advantageous in several respects, since it does not require ionizing radiation or iodinated contrast, thereby facilitating repeated or follow-up scanning. However, long data acquisition time remains as one of its main limitations. Several approaches have been studied to facilitate rapid CMR acquisition. Nonetheless, the acquisition time for high-resolution CMR remains long, and spatial and temporal resolution is traded off for acquisition time. Therefore, developments of methods to reduce the duration of data acquisition beyond what is available now are appealing. The investigators will develop novel reconstruction methodologies for high-resolution CMR that learn the anatomical structures in the images being reconstructed. The investigators will validate these techniques in a range of contrast-enhanced CMR imaging protocols, providing better volumetric coverage of the heart, efficient use of the contrast agents, and higher spatial and temporal resolution.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • "Healthy" subjects 18 years and older
  • Cardiovascular disease patients referred from the Department of Cardiology, who do not meet any of the exclusion criteria.

排除标准

  • Exclusion criteria include those associated with the use of MR as the imaging modality. Patients with pacemakers, implanted cardioverter-defibrillators, intracerebral clips or other implants that are not MR incompatible, atrial flutter or frequent atrial or ventricular ectopic activity, weight over 250 pounds, or significant claustrophobia will be excluded.
  • Subjects should not have the following which may be hazardous to their health or interfere with MRI examinations: cardiac pacemaker; implanted cardiac defibrillator; carotid artery vascular clamp; intravascular stents, filters, or coils; aortic clip; internal pacing wires; vascular access port and/or catheter; Swan-Ganz catheter; shunt (spinal or intraventricular); aneurysm clip(s); neurostimulator; electrodes (on body, head, or brain);heart valve prosthesis; any type of prosthesis (eye, penile, etc.); artificial limb or joint replacement; bone growth/fusion stimulator; bone/joint pin, screw, nail, wire, plate; metal rods in bones; Harrington rods (spine); metal or wire mesh implants; wire sutures or surgical staples; insulin pump or infusion device; any metal fragments (i.e. metal shop); any implant held in place by a magnet; cochlear, otologic, or ear implant.

研究组 & 干预措施

CMR

Subjects with no contraindication to magnetic resonance imaging, who will undergo cardiac MRI scanning.

干预措施: MRI Contrast (Drug)

结局指标

主要结局

left and right ventricular volumes and masses,

时间窗: 1 and 3 years

quantitative measures

Quantitative comparison of the proposed techniques with existing imaging techniques

时间窗: 1 and 3 years

vessel length and sharpness

high-resolution approaches with existing standard resolution imaging technique

时间窗: 1 and 3 years

quantitative measures

infarct size,

时间窗: 1 and 3 years

quantitative measures

time-intensity-curve upslopes,

时间窗: 1 and 3 years

quantitative measures

次要结局

  • presence of stenosis (yes/no dichotomous)(1 and 3 years)
  • presence of infarct (yes/no dichotomous),(1 and 3 years)
  • image quality (scores range from 1 [poor] to 4 [excellent]).(1 and 3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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