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临床试验/NCT00586183
NCT00586183已完成不适用

Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2006年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
1
试验地点
2
主要终点
Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction

研究概览

简要总结

Our hypothesis is that altered cardiac sympathetic activity is present and may contribute to the myocardial stunning observed in the apical ballooning syndrome.

Aim: Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction using carbon-11 hydroxyephedrine (C-11 HED), a positron emission tomography (PET) tracer, in patients with the apical ballooning syndrome.

详细描述

General methods: Five patients will undergo PET scans within a few days of or during the initial hospital admission for apical ballooning syndrome and during follow-up at 4 to 6 weeks to evaluate regional perfusion using N-13 ammonia and cardiac sympathetic activity with C-11 HED.

PET scanning protocol On the morning of the study, patients will arrive at the Mayo Clinic PET Imaging Center in a fasting state. The use of medications will be ascertained and recorded. An intravenous cannula will be placed in each arm. The subject will then be positioned in the PET scanner . After optimal positioning of the left ventricle within the field of view, a transmission scan will be performed with either a germanium-68 or CT source for subsequent attenuation correction. The PET scanning sequence is outlined below. Because 11C-HED uptake is dependent on flow characteristics, a flow study will be performed using N-13 ammonia. N-13 ammonia (10 to 20 mCi) will be injected over 20 seconds, and dynamic acquisition will be performed for 20 minutes with the following sequence:16 frames at 3 seconds, 10 frames at 12 seconds, and 2 frames at 240 seconds. Following a 50-minute period of N-13 ammonia decay, 11C-HED (20mCi) will be injected over 30 seconds, and a dynamic acquisition will be performed with the following sequence: 6 frames at 30 seconds, 2 frames at 60 seconds, 2 frames at 150 seconds, 2 frames at 300 seconds, 2 frames at 600 seconds, and 1 frames at 1,200 seconds. To correct for 11C-metabolites in the blood activity, venous samples will be drawn at 0, 1, 5, 10, 20, 40, and 60 minutes (total ~25 ml of blood) after the injection of C-11 HED. Heart rate, systemic blood pressure, and a 12-lead electrocardiogram will be obtained noninvasively with each peak isotope activity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Transient akinesis or dyskinesis of the left ventricular apical and mid-ventricular segments with regional wall-motion abnormalities extending beyond a single epicardial vascular distribution.
  • Absence of obstructive coronary disease or angiographic evidence of acute plaque rupture.
  • New electrocardiographic abnormalities (either ST-segment elevation or T-wave inversion.
  • Absence of recent significant head trauma, intracranial bleeding, pheochromocytoma, myocarditis, hypertrophic cardiomyopathy.

排除标准

  • Hemodynamically unstable patients (requiring pressor support) will be excluded.
  • Breastfeeding women.
  • Pregnant women (urine pregnancy test required within 48 hours prior to each set of PET scans.

结局指标

主要结局

Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction

时间窗: During PET scan

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

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