Bidirectional Cohort Study on Improvement of Quality of Life in Patients After Coronary Intervention With Kuanxiong Aerosol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The improvement of quality of life in two groups after one month of treatment
研究概览
简要总结
The goal of this observational study is to compare in patients with Angina Pectoris after PCI for Coronary Heart Disease. The main questions it aims to answer are:
- To evaluate the effect of Kuanxiong Aerosol on the quality of life of patients with angina pectoris after PCI for Coronary Heart Disease.
- To evaluate the effect of Kuanxiong Aerosol on relieving angina pectoris and improving cardiac function.
The comparison group will received routine treatment .The experimental group will received sublingual spray of Kuanxiong Aerosol on the basis of routine treatment，two sprays per time，three times a day, for a continuous month. After 1 month of treatment, the quality of life, the improvement of cardiac function and the relief of angina pectoris were compared between the two groups. Researchers will compare two groups to see if Kuanxiong Aerosol can improve the quality of life, cardiac function, and reduce the frequency and duration of angina pectoris in patients with angina pectoris after PCI.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for coronary heart disease
- •Age 18~80 years old, male and female, lower limbs can move freely
- •Patients with coronary angiography or coronary CT angiography indicating that the rate of coronary artery large vessel stenosis is greater than 80%
- •Patients with angina pectoris (angina pectoris frequency ≥3 times/week) after PCI according to the judgment of the treating physician
- •According to the doctor's judgment, patients who need to use conventional drugs (ACEI/ARB, β-blockers), and patients who need to use Kuanxiong Aerosol drugs on the basis of conventional drug therapy
- •Patients voluntarily sign informed consent
排除标准
- •Allergic to ingredients contained in Kuanxiong Aerosol
- •Coronary artery bypass grafting was prepared during the trial
- •Blood lipid and uric acid exceeding 1.5 times the upper limit of normal reference value; Uncontrolled severe hypertension with systolic blood pressure >180mmHg and/or diastolic blood pressure >110mmHg
- •severe hepatic and renal insufficiency (ALT, AST or TBIL>1.5 times the upper limit of normal reference value, Cr >1.5 times the upper limit of normal reference value)
- •Malignant tumors
- •Severe arrhythmias (such as rapid atrial fibrillation, ventricular tachycardia, high atrioventricular block, etc.)
- •Women who are pregnant or trying to become pregnant
- •The researcher judged that it is not suitable to participate in this study
结局指标
主要结局
The improvement of quality of life in two groups after one month of treatment
时间窗: Baseline and 1 months.
Compare the changes in SF-36 scores before and after treatment between two groups of patients. SF-36 consists of 9 dimensions and 36 items: Physical Functioning (PF), Role Limitations due to Physical Health (RP), Bodily Pain (BP), General Health Perception (GH), Vitality (VT), Social Functioning (SF), Role Limitations due to Emotional Problems (RE), and Mental Health (MH). SF-36 can be self-administered, interviewer-administered, or conducted via telephone inquiry. The main statistical indicator for SF-36 is calculating the health scores for the eight dimensions. Based on the rescaled values of each item within each dimension, initial and final scores can be calculated for these eight dimensions. The scoring method involves summing up the weighted scores of individual items within each dimension to obtain a raw score for that dimension, which is then converted into a standardized score ranging from 0 to 100. Higher scale scores indicate better quality of life.
次要结局
- The relief of angina pectoris and the improvement of cardiac function in the two groups after one month of treatment(Baseline and 1 months.)