Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05050773
Other study ID # MEDSCI20210407
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 13, 2021
Est. completion date June 10, 2023

Study information

Verified date July 2023
Source Beijing Anzhen Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1556
Est. completion date June 10, 2023
Est. primary completion date June 10, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Anzhen Hospital, Capital Medical University Beijing Beijing
China Beijing Changping District Hospital Beijing Beijing
China Beijing Daxing District People's Hospital Beijing Beijing
China Beijing Huaxin Hospital Beijing Beijing
China Beijing Jishuitan Hospital Beijing Beijing
China Beijing Miyun District Hospital Beijing Beijing
China Beijing Shijitan Hospital Beijing Beijing
China Dezhou People's Hospital Dezhou Shandong
China Huai'an Hospital of Traditional Chinese Medicine Huai'an Jiangsu
China Ruyang People's Hospital Luoyang Henan

Sponsors (2)

Lead Sponsor Collaborator
Beijing Anzhen Hospital Beijing Life oasis public service center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary SAQ-SS change at Month 12 Change in Seattle Angina Questionnaire (SAQ) summary score at Month 12 from baseline at Month 12
Secondary SAQ-SS change at Month 3, 6 and 9 Changes in Seattle Angina Questionnaire (SAQ) summary score at Months 3, 6, and 9 from baseline at Month 3, 6 and 9
Secondary Vascular stenosis degree change at Month 12 Changes in retest results of vascular stenosis imaging at Month 12 from baseline at Month 12
Secondary Medication compliance Medication compliance evaluated by proportion of days covered (PDC) 12 Month
See also
  Status Clinical Trial Phase
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT02773615 - CT Perfusion Added to CT Angiography
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Terminated NCT02548611 - Comparison of Loading Strategies With Antiplatelet Drugs in Patients Undergoing Elective Coronary Intervention Phase 4
Completed NCT02264717 - Dan-NICAD - Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease N/A
Completed NCT02440893 - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Completed NCT01425359 - Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina Phase 4
Completed NCT01486030 - Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test
Completed NCT01604486 - Natural Ischaemic Preconditioning Before First Myocardial Infarction N/A
Completed NCT00811772 - Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis N/A
Completed NCT00131183 - Testosterone Therapy on Angina Threshold and Atheroma in Patients With Chronic Stable Angina Phase 4
Completed NCT00184444 - Effect of Increased Oxygenation in the Air During Endurance Training in Stable Angina Pectoris Patients N/A
Completed NCT00235404 - Randomized Controlled Trial of Health Care to Elderly Patients. N/A
Terminated NCT00157742 - Comparison of SCS and PMR in Patients With Refractory Angina Pectoris Phase 4
Completed NCT00000510 - Platelet-Inhibitor Drug Trial in Coronary Angioplasty Phase 3
Completed NCT00005148 - Coronary Heart Disease Incidence, Mortality, and Risk Factor Relationships N/A
Not yet recruiting NCT03657758 - Lesional Evaluation of High Risk Patients With Neoatherosclerosis Treated With Rosuvastatin and Eicosapentaenoic Acid Using Optical Coherence Tomography(OCT)[LINK IT TWO] Phase 4
Completed NCT00093223 - A Safety Study of ABI-007 for In-Stent Restenosis Phase 2
Active, not recruiting NCT02508714 - Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents N/A
Recruiting NCT02623569 - To Assess the Anti-anginal Safety and Efficacy of Ivabradine in Subjects With Stable,Symptomatic Chronic Angina Phase 2