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临床试验/NCT02515812
NCT02515812已完成不适用

Comparative Study of Cardiac Adrenergic Function Explored by I-123-MIBG and CZT Camera (D-SPECT) Versus Anger Camera in Patients With Heart Failure

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
SRSI (summed rest score innervation)

研究概览

简要总结

Cardiological examination constitute one of the major directions in nuclear medicine for detection of myocardial ischemia in patients suspected of coronary disease. In Caen, they constitute 20% of the activity of nuclear medicine. Systolic heart failure (HF) ischemic or nonischemic origin represents a new area of activity of the nuclear cardiology. This is HF stratification study based on cardiac adrenergic function after injection of a tracer: I-123-MIBG. The team Caen nuclear cardiology is one of two teams recognized internationally in the field of evaluating the cardiac sympathetic innervation in cardiomyopathies. Numerous publications from 1992 to the present day have reported encouraging results for the daily use of this tracer in the evaluation of patients with LV dysfunction IC. Recently, interest in using the MIBG has been shown as a prognostic marker of HF in a prospective study of 961 patients. Typically, the camera used was an Anger camera with collimating Nai standard called parallel holes.

The main objective is to validate the measurements of cardiac adrenergic function evaluated by cardiopulmonary mediastinal reports and sympathetic innervation scores VG after injection of I-123-MIBG in 80 patients with heart failure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 years (except major patients under guardianship)
  • patient who signed the consent form
  • written and spoken French
  • Beneficiaries of the social security system
  • Stable heart failure with LV dysfunction (<45%) of ischemic or nonischemic origin

排除标准

  • Patients with a recent history (<21 days) acute coronary failure (myocardial infarction, unstable angina)
  • Patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment)
  • Major patients under guardianship
  • Pregnant or lactating women
  • Women in age and condition of childbearing
  • Patients unable to understand the purpose of the study

研究组 & 干预措施

Adrenergic Function Explorations with CZT camera

Experimental

I-123-MIBG and CZT Camera (D-SPECT)

干预措施: I-123-MIBG (Drug)

Adrenergic Function Explorations with CZT camera

Experimental

I-123-MIBG and CZT Camera (D-SPECT)

干预措施: CZT Camera (D-SPECT) (Device)

Adrenergic Function Explorations with Anger camera

Active Comparator

I-123-MIBG and Anger Camera

干预措施: I-123-MIBG (Drug)

Adrenergic Function Explorations with Anger camera

Active Comparator

I-123-MIBG and Anger Camera

干预措施: Anger Camera (Device)

结局指标

主要结局

SRSI (summed rest score innervation)

时间窗: 4 hours after I-123-MIBG perfusion

with CZT camera and Anger camera

SRS (summed rest score)

时间窗: 4 hours after I-123-MIBG perfusion

with CZT camera and Anger camera

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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