Coronary ARteriogenesis With Combined Heparin and EXercise Therapy in Chronic Refractory Angina
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from Baseline Canadian Cardiovascular Society (CCS) angina severity class at 2 weeks
研究概览
简要总结
This study evaluates the addition of heparin to a 2-week cycle of physical rehabilitation in the treatment of refractory angina. Half of the patients will undergo heparin-primed physical rehabilitation, while the other half will undergo only physical rehabilitation.
详细描述
Our approach is based on the combination of pharmacological stimuli (with heparin) on top of a 2-week cycle of physical rehabilitation. The rationale for this chemical-physical cocktail stems from the fact that increase in shear stress (achieved with exercise), or heparin (when used alone) have no significant effect on coronary arteriogenesis. Nevertheless, when the two stimuli are coupled coronary arteriogenesis is consistently present, and clinically significant.
The basic principle of heparin treatment is to potentiates angiogenic growth factors, which are over expressed by increased shear stress at the site of pre-existing collateral vessels as a result of exercise or pacing. Although the precise mechanisms by which heparin potentiates arteriogenesis remain to be completely elucidated, heparin administration combined with exercise has great potential in treating patients with effort angina who are not indicated for conventional revascularization therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with documented coronary artery disease not amenable of future treatment and belonging to "no-option" category with symptoms consistent with angina pectoris
排除标准
- •Patients with unstable angina, recent myocardial infarction, uncontrolled hypertension, hemodynamically valvular heart disease, bronchial asthma, and neurologic and/or orthopedic illnesses that limit exercise capacity .
- •Patients receiving vitamin K antagonist.
- •Patients actively involved in programmes of cardiac rehabilitation or exercise training.
研究组 & 干预措施
Heparin-primed physical rehabilitation
2 exercise sessions per day for 5 days a week for 2 weeks with 100 IU/kg of Heparin i.v. (up to a maximum of 5000 IU) 10 minutes prior to exercise
干预措施: Physical rehabilitation (Other)
Heparin-primed physical rehabilitation
2 exercise sessions per day for 5 days a week for 2 weeks with 100 IU/kg of Heparin i.v. (up to a maximum of 5000 IU) 10 minutes prior to exercise
干预措施: Heparin (Drug)
Placebo-primed physical rehabilitation
2 exercise sessions per day for 5 days a week for 2 weeks with placebo (2 ml of Sodium Chloride 0.9% i.v.) 10 minutes prior to exercise
干预措施: Physical rehabilitation (Other)
Placebo-primed physical rehabilitation
2 exercise sessions per day for 5 days a week for 2 weeks with placebo (2 ml of Sodium Chloride 0.9% i.v.) 10 minutes prior to exercise
干预措施: Placebo (Other)
结局指标
主要结局
Change from Baseline Canadian Cardiovascular Society (CCS) angina severity class at 2 weeks
时间窗: 2 weeks
CCS class ranging from 1 (mild) to 4 (severe) before and after the 2-week physical rehabilitation.
次要结局
- Change from baseline peak stress global longitudinal strain (GLS) at 2 weeks(2 weeks)
- Change from Baseline peak stress wall motion score index (WMSI) at 2 weeks(2 weeks)
研究者
Branko Beleslin
Clinical research
Clinical Centre of Serbia