Enhanced External Counterpulsation and Its Effects on Vascular Hemodynamics in Cognitively Impaired Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Cognitive Function
研究概览
简要总结
The aim of this study is to investigate whether enhanced external counterpulsation (EECP) therapy for 7 consecutive weeks will improve cerebral blood flow and possibly over time enhance or slow down breakdown of cognitive function in patients diagnosed with mild cognitive impairment (MCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An adult between 18 and 85 years of age.
- •Has been evaluated to have a CDR (Clinical Dementia Rating) Score of 0.5
- •Male or female (if female must be postmenopausal for at least 1 year, surgically sterile or using an effective form of contraception).
- •Able to speak and read English.
- •Willing to comply with study specific instructions, and complete all study procedures according to protocol.
- •Able to understand study rationale and sign informed consent.
排除标准
- •Diagnosed with glaucoma
- •History of developing adverse effects to ophthalmic dilating agents (phenylephrine or tropicamide).
- •Currently taking warfarin and dabigatran (Pradaxa).
- •History of having arrhythmias - can interfere with EECP triggering.
- •Subject has bleeding diathesis.
- •Subject has active thrombophlebitis.
- •Subject has severe lower extremity vaso-occlusive disease.
- •Subject has a documented aortic aneurysm requiring surgical repair.
- •Subject is pregnant.
- •Subject with blood pressure higher than 180/110 mmHg.
- •Subject with a heart rate more than 120 bpm.
- •Subject with high risk of complications from increased venous return.
- •Subject with clinically significant valvular disease.
- •Subjects with severe vascular disease as established by the Hachinski Ischemic Index.
- •Subjects with pacemakers and other metallic implantable devices.
研究组 & 干预措施
Enhanced external counterpulsation (EECP)
干预措施: External Counterpulsation (EECP) (Device)
Subjects not receiving EECP
Control group to measure data from experimental group against.
结局指标
主要结局
Change in Cognitive Function
时间窗: Baseline, Week 7, 6 Month
Change in cognitive function measured using the Alzheimer's Disease Assessment Scale-cognitive sub-scale (ADAS-cog). Scale is used to determine patient's mental status. The scale has 11 parts and scores range from 0 (no impairment) to 70 (severe impairment).
次要结局
- Cholesterol composition of the blood(Baseline to week 7)
- Change in Blood Viscosity(Baseline to Week 7)
- Change in Ophthalmic blood flow (OBF)(Baseline to Week 7)
研究者
Patrick Moriarty, MD, FACP, FACC
Director, Clinical Pharmacology
University of Kansas Medical Center