A Real-world Study of Clinical Characteristics, Treatment Patterns and Effectiveness in Chinese Patients With Angina Pectoris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,556
- 试验地点
- 10
- 主要终点
- SAQ-SS change at Month 12
研究概览
简要总结
The study will be a multi-center, prospective, cohort study based on registration of Chinese angina pectoris patients. After signing the informed consent, all patients will be screened as per the inclusion and exclusion criteria. Estimated 1500 eligible patients will be enrolled. Two natural cohort will be formed according to whether Nicorandil will be prescribed to patients or not. The baseline information of patients will be recorded and patients will be followed up to observe the effectiveness of different anti-angina regimens. Follow-up visits will be conducted at Month 3, 6, 9, 12 after enrollment. The visits at Months 3, 6 and 9 will be conducted in the form of electronic patient reported outcomes (ePRO) + telephone follow-up, and the visit at Month 12 will be conducted on site. Patients are required to fill in the patient diary records (weekly) during the course of the study.
This study is designed to establish a cohort of Chinese angina pectoris patients and compare the effectiveness of different anti-angina regimens in patients with angina pectoris.
详细描述
After having signed informed consent (Day 0), the patients will be screened for enrollment. About 1500 eligible patients will be enrolled in this study. The basic information of eligible patients including demographic characteristics, history of present illness, past history, Rose questionnaire, vital sign, medication information, SAQ and other optional examination data will be collected at Day 0. At Day 0, the patients will join the study Wechat Mini Program developed for online follow up and patient education by scan the QR code provided by investigators. After enrollment, the following information will be collected by ePRO with WeChat Mini Program or telephone follow up of month 3, 6 and 9: vital sign, medication information, SAQ, AE. The follow up of month 12 will be conducted on site which will collect SAQ, AE and other optional examination data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with angina pectoris who have evidence of coronary angiography or coronary computed tomography angiography (CTA) performed within 1 year and meet any of the following requirements:
- •Imaging examination shows ≥ 50% stenosis and with typical or atypical angina symptoms;
- •Imaging examination shows < 50% stenosis; with typical or similar angina symptoms, and the treadmill exercise test or stress echocardiography or radionuclide stress test results are positive;
- •Post-PCI stenosis of left vessels is ≥ 50%;
- •Currently taking or judged by the physicians as suitable to taking at least one oral antianginal drug (e.g., beta-blockers, nitrates, calcium antagonists and potassium channel openers);
- •Have basic reading and writing abilities, and can correctly fill in the Seattle Angina Questionnaire(SAQ) after being trained by the investigator;
- •Able to use smart phones;
- •Voluntarily participate in the study and sign the informed consent form.
排除标准
- •Have been diagnosed with malignant tumors that seriously threaten survival and have expected survival time of less than 1 year;
- •Have participated in other clinical studies within the past 1 month;
- •With poor compliance or with other conditions unsuitable for this study as assessed by physicians.
结局指标
主要结局
SAQ-SS change at Month 12
时间窗: at Month 12
Change in Seattle Angina Questionnaire (SAQ) summary score at Month 12 from baseline
次要结局
- SAQ-SS change at Month 3, 6 and 9(at Month 3, 6 and 9)
- Vascular stenosis degree change at Month 12(at Month 12)
- Medication compliance(12 Month)
研究者
Yong Zeng
Professor and Director, First Ward of Coronary Heart Disease Center
Beijing Anzhen Hospital