The Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Artery Plaques in Patients With Moderate Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS
研究概览
简要总结
Nebivolol is a novel blood pressure lowering drug with an additional effect on the inner lining of blood vessels to release a compound called nitric oxide that can relax blood vessels. Atenolol is a blood pressure reducing agent without the ability to release nitric oxide and effect additional blood vessel relaxation.
The goal of this proposal is to compare Nebivolol and Atenolol with respect to the following parameters:
- Plaque within arteries supplying the heart in terms of its volume and composition as assessed by ultrasound within these arteries.
- Ability of small arteries in the heart to open up and deliver an enhanced blood supply in response to drug called Adenosine (routinely used in the cardiac catheterization laboratory) as assessed by pressure and flow detecting catheters within these arteries.
- Ability of the inner lining of arteries that supply the heart to release a relaxing compound called nitric oxide in response to injection of Acetylcholine (also used in the cardiac catheterization laboratory) as assessed by squirting dye into these arteries
- Local forces that affect blood flow in the arteries supplying the heart as assessed by superimposing the above data into complex maps created offline at Georgia Institute of Technology.
It is likely that Nebivolol causes the plaque within arteries supplying the heart to change from the 'vulnerable' type to the 'stable' type plaque. There are several features of "vulnerable plaques" that can be detected in arteries of the heart using intravascular ultrasound (a small ultrasound camera that goes in the arteries of the heart). The investigators hypothesis is that Nebivolol will prove superior to Atenolol in reducing 'vulnerable plaques', improve blood flow within the small arteries and the health of inner lining of these arteries at the 1 year time point. The investigators plan to enroll 20 patients into the study (26 patient including dropouts) who will be randomized in a 1:1 manner to Nebivolol Vs Atenolol for 1 year and repeat evaluation at that time point.
详细描述
Primary hypothesis:
Nebivolol therapy will reduce the number of thin-cap fibroatheromas, VH-IVUS defined "vulnerable plaques" compared to Atenolol in patients undergoing serial angiography and IVUS.
Secondary Hypotheses:
- Nebivolol therapy will improve coronary microvascular function
- Nebivolol therapy will improve coronary endothelial function
- Nebivolol therapy will improve coronary wall shear stress
Specific Aims:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stable angina or acute coronary syndrome
- •Moderate coronary lesion (defined as a lesion significant enough by the treating physician to warrant further evaluation using CFR or FFR or intravascular ultrasound assessment).
- •Lesion located in the proximal 60mm of the RCA or LAD.
- •On stable medical therapy for other cardiac risk factors.
排除标准
- •Left Main lesion greater than 50% stenosis
- •Patients with a history of coronary artery bypass surgery
- •Severe valvular heart disease
- •Patients presenting with a STEMI.
- •Inability to provide informed consent prior to randomization
- •Creatinine >1.5
- •Lesions located beyond 60mm in an epicardial vessel
- •Coronary anatomy requiring CABG
- •B-blocker, calcium channel blocker or extended-release nitrate therapy within last 48 hours.
- •Bradycardia (HR<50 bpm)
- •Hypotension (SBP<100mmHg)
- •Severe COPD by pulmonary function testing
研究组 & 干预措施
Nebivolol
干预措施: Nebivolol (Drug)
Atenolol
干预措施: Atenolol (Drug)
结局指标
主要结局
Number of Participants With Reduction of Thin-cap Fibroatheromas (TCFA) as Defined by VH-IVUS
时间窗: 1 year
Presence of thin-cap fibroatheroma as defined by virtual histology-intravascular ultrasound (VH-IVUS)
次要结局
未报告次要终点