Clinical trial NCT05050773: Registry Study of Medical Therapy in Patients With Angina Pectoris(GREAT)
Official title: A Real-world Study of Clinical Characteristics, Treatment Patterns and Effectiveness in Chinese Patients With Angina Pectoris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina Pectoris
Real World Study
Keywords: Angina Pectoris
Real World Study
Nicorandil
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Life oasis public service center
First posted: 2021-09-21
Enrollment: 1556
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: angina pectoris patients

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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1. 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:

1. Imaging examination shows ≥ 50% stenosis and with typical or atypical angina symptoms;
2. 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;
3. Post-PCI stenosis of left vessels is ≥ 50%; 2. 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); 3. Have basic reading and writing abilities, and can correctly fill in the Seattle Angina Questionnaire(SAQ) after being trained by the investigator; 4. Able to use smart phones; 5. Voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

1. Have been diagnosed with malignant tumors that seriously threaten survival and have expected survival time of less than 1 year;
2. Have participated in other clinical studies within the past 1 month;
3. With poor compliance or with other conditions unsuitable for this study as assessed by physicians.

Primary outcomes:
measure: SAQ-SS change at Month 12
timeFrame: at Month 12
Secondary outcomes:
measure: SAQ-SS change at Month 3, 6 and 9
timeFrame: at Month 3, 6 and 9
measure: Vascular stenosis degree change at Month 12
timeFrame: at Month 12
measure: Medication compliance
timeFrame: 12 Month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Changping District Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Daxing District People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Huaxin Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Miyun District Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
city: Luoyang
country: China
facility: Ruyang People's Hospital
state: Henan
city: Huai'an
country: China
facility: Huai'an Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Dezhou
country: China
facility: Dezhou People's Hospital
state: Shandong
Study officials:
affiliation: Anzhen hospital, Capital medical university
name: Yong Zeng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anzhen hospital, Capital medical university
name: Xiliang Zhao, MD
role: STUDY_DIRECTOR
References: