PMID- 36737594
OWN - NLM
STAT- MEDLINE
DCOM- 20230405
LR  - 20231003
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 40
IP  - 4
DP  - 2023 Apr
TI  - Clinical Characteristics, Treatment Patterns, and Effectiveness in Chinese 
      Patients with Angina Pectoris Using Electronic Patient-Reported Outcomes: 
      Protocol for a Multicenter, Prospective, Cohort Study (GREAT).
PG  - 1899-1912
LID - 10.1007/s12325-023-02425-0 [doi]
AB  - BACKGROUND: Angina pectoris (AP) is the initial and the most common manifestation 
      of coronary artery disease (CAD). Therefore, management and control of AP can 
      help prevent further complications associated with CAD. However, there is 
      under-reporting of angina symptoms in clinical practice, resulting in 
      under-treatment and reduced quality of life (QoL). Prospective and standardized 
      monitoring is needed to support timely and appropriate treatment. OBJECTIVES: To 
      establish a large cohort of Chinese patients with AP and compare the 
      effectiveness of different anti-angina regimens with the help of electronic 
      patient-reported outcomes (e-PROs), using the Seattle Angina Questionnaire (SAQ) 
      to assess health status. METHODS: The registry study (GREAT) is a multicenter, 
      prospective, observational, cohort study. Patients diagnosed with AP will be 
      enrolled from 10 hospitals and assessed based on the different anti-anginal 
      regimens. Patients will be followed up every 3 months from baseline to 12 months 
      to observe the difference in the therapeutic effectiveness of the drugs. Data 
      will be collected in the form of e-PROs combined with on-site visit records. 
      PLANNED OUTCOMES: The change in SAQ summary score (SAQ SS) at Month 12 from 
      baseline will be the primary outcome. The secondary measures will include changes 
      in SAQ SS at Months 3, 6, and 9 from baseline, changes in retest results of 
      vascular stenosis imaging at Month 12 from baseline, and medication adherence 
      based on the proportion of days covered. Safety data will be evaluated based on 
      the incidence of adverse events (AEs). CONCLUSION: This study will evaluate the 
      effectiveness of anti-anginal regimens using ePROs in real-world settings in 
      China. The results from this study may provide a new perspective on treatment 
      patterns and the effectiveness of different anti-anginal regimens for patients 
      with AP. STUDY REGISTRATION NUMBER: NCT05050773.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Healthcare Ltd., part 
      of Springer Nature.
FAU - Zhao, Xiliang
AU  - Zhao X
AD  - Center for Cardiology, Beijing Anzhen Hospital, Beijing, 100029, China.
FAU - Tong, Zichuan
AU  - Tong Z
AD  - Department of Cardiology, Beijing Daxing District People's Hospital, Beijing, 
      China.
FAU - Sun, Liling
AU  - Sun L
AD  - Department of Cardiology, Beijing Changping District Hospital, Beijing, China.
FAU - Zhang, Qihua
AU  - Zhang Q
AD  - Department of Cardiology, Beijing Miyun District Hospital, Beijing, China.
FAU - Du, Xin
AU  - Du X
AD  - Center for Cardiology, Beijing Anzhen Hospital, Beijing, 100029, China.
FAU - Xu, Su'e
AU  - Xu S
AD  - Department of Cardiology, Huai'an Hospital of Traditional Chinese Medicine, 
      Beijing, China.
FAU - Shen, Chengning
AU  - Shen C
AD  - Department of Cardiology, Ruyang People's Hospital, Ruyang, China.
FAU - Wei, Ying
AU  - Wei Y
AD  - Department of Cardiology, Dezhou People's Hospital, Dezhou, China.
FAU - Liu, Wei
AU  - Liu W
AD  - Department of Cardiology, Beijing Jishuitan Hospital, Beijing, China.
FAU - Miao, Lifu
AU  - Miao L
AD  - Department of Cardiology, Beijing Huaxin Hospital, Beijing, China.
FAU - Zeng, Yong
AU  - Zeng Y
AUID- ORCID: 0000-0002-3470-508X
AD  - Center for Cardiology, Beijing Anzhen Hospital, Beijing, 100029, China. 
      yzeng_anzhen@163.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT05050773
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230204
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Cardiovascular Agents)
MH  - Humans
MH  - Quality of Life
MH  - Cohort Studies
MH  - Prospective Studies
MH  - East Asian People
MH  - Treatment Outcome
MH  - Angina Pectoris/diagnosis/drug therapy
MH  - *Coronary Artery Disease/complications/drug therapy
MH  - *Cardiovascular Agents/therapeutic use
MH  - Patient Reported Outcome Measures
MH  - Multicenter Studies as Topic
OTO - NOTNLM
OT  - Angina pectoris
OT  - Anti-anginal regimens
OT  - Study protocol
OT  - e-PRO
EDAT- 2023/02/04 06:00
MHDA- 2023/04/05 06:42
CRDT- 2023/02/03 23:39
PHST- 2022/10/14 00:00 [received]
PHST- 2023/01/03 00:00 [accepted]
PHST- 2023/04/05 06:42 [medline]
PHST- 2023/02/04 06:00 [pubmed]
PHST- 2023/02/03 23:39 [entrez]
AID - 10.1007/s12325-023-02425-0 [pii]
AID - 10.1007/s12325-023-02425-0 [doi]
PST - ppublish
SO  - Adv Ther. 2023 Apr;40(4):1899-1912. doi: 10.1007/s12325-023-02425-0. Epub 2023 
      Feb 4.