Effect of Alprazolam on Heart Rate and Acute Inflammatory Marker in Acute Coronary Syndrome Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- recurrent symptomatic ischemia
研究概览
简要总结
Cardiovascular disease has always been one of the most concerning ailments of all times considering mortality. On one end due to the emergence of pharmaceutical technology, there is a reduction in mortality, on the other hand owing to a sedentary lifestyle the incidence of this disease is increasing. Hence leading to up slopping trend in cardiovascular prevalence. Acute coronary syndrome is one of the most deadly and acute presentations of cardiology requiring immediate intervention to dampen the frequency of complications. One of the fundamental goals in the treatment of ACS is to lower the heart rate so that load on myocardial tissue can be reduced. In order to do so, we already have multiple options like beta-blockers, calcium channel blockers, and new generation ivabradine (not affecting blood pressure unlike others).
详细描述
World has studied the increased prevalence of anxiety as a concomitant factor in ACS patients causing detrimental effects on cardiovascular outcomes being anxiety as one of the first responses to chest pain and hospital admission causing tachycardia. This study is designed to achieve the goals of lowering the heart using the anxiolytic property of alprazolam. This randomized, parallel group, close label, placebo-controlled, event driven, interventional clinical superiority study will be conducted in Cardiology department of Shaikh Zayed Hospital with a sample size of 48 allocating using lottery method in both experimental and control group. Heart Rate at baseline and after 6 hours will be monitored in both groups to establish the fall of heart rate in both patients. Data will be collected by using pre-designed performa and will be entered and analyzed via SAS 9.4. Statistical analysis will be done using T-test and p value <0.05 will be considered significant.
Significance of the study is to lower the required dosage of beta-blockers in order to achieve optimum beta-blockade using an anxiolytic while not affecting the blood pressure.
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)
盲法说明
Masking will be done for all participants
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic BP>100mm Hg Age between 18-80 years Sinus Rhythm
排除标准
- •Cardiogenic Shock / Hypotension
- •Known Asthma/COPD
- •Bradycardia (HR < 60)
- •Already on Beta blockers/ Anxiolytics
- •Sick sinus syndrome
- •Second or third-degree heart block (in the absence of pacemaker)
- •Decompensated heart failure
- •With documented hypersensitivity to the drug or components
- •Valvular Heart Diseases
- •Congenital Heart Diseases
- •Status post CABG
- •Any co-morbidities except Diabetes Mellitus and Hypertension
研究组 & 干预措施
Alprazolam Arm
0.5mg Alprazolam will be given to the patient at the time of presentation
干预措施: Alprazolam (Drug)
Placebo Arm
The empty capsule will be given to the patient at the time of presentation
干预措施: Placebo (Other)
结局指标
主要结局
recurrent symptomatic ischemia
时间窗: 72 hours
episodes of angina
Duration of Hospital stay
时间窗: upto 14 days
Number of days
Mortality
时间窗: upto 14 days
death of patients
Heart Rate
时间窗: upto 72 hours
Heart Rate reduction
erythrocyte sedimentation rate (ESR)
时间窗: upto 72 hours
Acute phase reactants
C-reactive protein (CRP)
时间窗: upto 72 hours
Acute phase reactants
次要结局
未报告次要终点
研究者
Sohaib Ashraf
Registrar Cardiology
Sheikh Zayed Federal Postgraduate Medical Institute