High Risk Population of Cardiovascular Disease in Hubei Province Screening and Intervention Program
1 other identifier
interventional
16,000
1 country
107
Brief Summary
High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program（CCDInT）is a randomized controlled study to verify that protocol treatment group is more effective than the conventional treatment group in reducing the incidence of composite cardiovascular disease (cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome) in patients with coronary heart disease and type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Jan 2023
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2023
CompletedFirst Submitted
Initial submission to the registry
February 18, 2023
CompletedFirst Posted
Study publicly available on registry
March 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 15, 2023
December 1, 2023
12 months
February 18, 2023
December 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Composite cardiovascular disease (cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome)
Record the composite cardiovascular disease(cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome)
1 year after baseline
Secondary Outcomes (12)
All-cause death
1 year after baseline
All-cause mortality
1 year after baseline
Cardiovascular death
1 year after baseline
non-fatal myocardial infarction
1 year after baseline
non-fatal stroke
1 year after baseline
- +7 more secondary outcomes
Study Arms (2)
Protocol treatment group
EXPERIMENTALStrictly intervene blood glucose, blood pressure and blood lipids
Conventional treatment group
PLACEBO COMPARATORTreatment and management according to the guidelines
Interventions
Use some methods to strictly intervene blood glucose , blood pressure and blood lipids for protocol treatment group people.
Treatment and management according to the guidelines
Eligibility Criteria
You may qualify if:
- years old, male or female
- Patients with coronary heart disease complicated with type 2 diabetes (confirmed by angiography)
- Low density lipoprotein cholesterol \>1.8mmol/l
- Willing to participate and sign informed consent
You may not qualify if:
- Received coronary stent treatment in recent one year
- Pregnant or lactating women
- Decompensated stage of chronic systolic heart failure (NYHA cardiac function rating ≥ 3), cardiac function; Patients with severe cardiovascular complications such as septic shock
- Stroke patients in recent 1 year
- Patients with severe gastrointestinal diseases, liver failure or kidney failure
- Cancer patients or patients who have received radiotherapy or chemotherapy within five years
- Suffering from infectious diseases such as AIDS and tuberculosis
- Hospitalized or suffering from other serious diseases requiring immediate hospitalization
- Bad addicts: drug users or alcoholics (men \>80 g / day, women \>40 g / day)
- Disturbance of consciousness, inability to communicate normally or any mental illness; Those who are inconvenient to take care of themselves or move
- Life expectancy \<12 months
- Individuals with abnormal laboratory tests and clinical manifestations who are judged by the researcher to be unsuitable for participation
- Unwilling to participate in the trial, unwilling to change the current drug treatment plan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (107)
Affiliated Minzu University Hospital of Hubei Minzu University
Enshi, Hubei, 445000, China
Badong Peolple's Hospital
Enshi, Hubei, 445000, China
Enshi Central Hospital
Enshi, Hubei, 445000, China
Laifeng People's Hospital
Enshi, Hubei, 445000, China
Lichuan People's Hospital
Enshi, Hubei, 445000, China
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, Hubei, 445000, China
The People's Hospital of Jianshi
Enshi, Hubei, 445000, China
Xianfeng County People's Hospital
Enshi, Hubei, 445000, China
Xuanen People's Hospital
Enshi, Hubei, 445000, China
Ezhou Central Hospital
Ezhou, Hubei, 436000, China
Ezhou Hospital of Chinese Medicine
Ezhou, Hubei, 436000, China
Hongan People's Hospital
Huanggang, Hubei, 438000, China
Huangmei Peolple's Hospital
Huanggang, Hubei, 438000, China
Luotian People's Hospital
Huanggang, Hubei, 438000, China
People's Hostpital of Macheng City
Huanggang, Hubei, 438000, China
Qichun People's Hospital
Huanggang, Hubei, 438000, China
The People's Hospital of Tuanfeng
Huanggang, Hubei, 438000, China
Wuxue People's Hopital
Huanggang, Hubei, 438000, China
Xishui People's Hospital
Huanggang, Hubei, 438000, China
Yingshan People's Hospital
Huanggang, Hubei, 438000, China
Daye People's Hospital
Huangshi, Hubei, 435000, China
Huangshi Central Hospital
Huangshi, Hubei, 435000, China
Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic University
Huangshi, Hubei, 435000, China
Yangxin People's Hospital
Huangshi, Hubei, 435000, China
Jingmen NO.1 People's Hospital
Jingmen, Hubei, 448000, China
Jingmen NO.2 People's Hospital
Jingmen, Hubei, 448000, China
Jingshan Union Hospital of Huazhong University of Science and Technology
Jingmen, Hubei, 448000, China
Zhongxiang Hospital of Traditional Chinese Medicine
Jingmen, Hubei, 448000, China
Zhongxiang People's Hospital
Jingmen, Hubei, 448000, China
Chinese Medicine Hospital of Gongan
Jingzhou, Hubei, 434000, China
Chinese Medicine Hospital of Honghu
Jingzhou, Hubei, 434000, China
Jiangling People's Hospital
Jingzhou, Hubei, 434000, China
Jianli Hospital of Chinese Medicine
Jingzhou, Hubei, 434000, China
Jianli People's Hospital
Jingzhou, Hubei, 434000, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434000, China
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, 434000, China
Jingzhou No.1 People's Hospital
Jingzhou, Hubei, 434000, China
People's Hospital of Gongan
Jingzhou, Hubei, 434000, China
People's Hospital of Honghu
Jingzhou, Hubei, 434000, China
Shishou People's Hostpital
Jingzhou, Hubei, 434000, China
Songzi of Traditional Chinese Medicine
Jingzhou, Hubei, 434000, China
Songzi People's Hospital
Jingzhou, Hubei, 434000, China
The Second Hospital of Jingzhou
Jingzhou, Hubei, 434000, China
The Second People's Hospital of Jianli
Jingzhou, Hubei, 434000, China
Danjiangkou First Hospital
Shiyan, Hubei, 442000, China
Fang County People's Hospital
Shiyan, Hubei, 442000, China
Shiyan Renmin Hospital
Shiyan, Hubei, 442000, China
Sinopharm Dongfeng General Hospital, Hubei University of Medicine
Shiyan, Hubei, 442000, China
Taihe Hospital
Shiyan, Hubei, 442000, China
Xunyang People's Hospital
Shiyan, Hubei, 442000, China
Yunxi People's Hospital
Shiyan, Hubei, 442000, China
Zhushan People's Hospital
Shiyan, Hubei, 442000, China
Zhuxi Hospital of Traditional Chinese Medicine
Shiyan, Hubei, 442000, China
NO.1 Peoples Hospital of Guangshui
Suizhou, Hubei, 441300, China
People's Hospital of Suixian
Suizhou, Hubei, 441300, China
Suizhou Central Hospital
Suizhou, Hubei, 441300, China
Suizhou Hospital of Traditional Chinese Medicine
Suizhou, Hubei, 441300, China
Suizhou Zengdu Hospital
Suizhou, Hubei, 441300, China
The First People's Hospital of Tianmen in Hubei Province
Tianmen, Hubei, 431700, China
CR & WISCO General Hospital
Wuhan, Hubei, 430000, China
Fifth Hospital in Wuhan
Wuhan, Hubei, 430000, China
Hospital of Universal Love
Wuhan, Hubei, 430000, China
People's Hospital of Dongxihu District
Wuhan, Hubei, 430000, China
The Central Hospital of Wuhan
Wuhan, Hubei, 430000, China
Union Hospital, Tongji Medical College of Huazhong University of science and technology
Wuhan, Hubei, 430000, China
Wuhan NO.1 Hospital
Wuhan, Hubei, 430000, China
Wuhan Third Hospital-Tongren Hospital of Wuhan University
Wuhan, Hubei, 430000, China
Huanggang Central Hospital
Wuhan, Hubei, 438000, China
Baokang People's Hospital
Xiangyang, Hubei, 441000, China
Gucheng People's Hospital
Xiangyang, Hubei, 441000, China
Laohekou NO.1 Hospital
Xiangyang, Hubei, 441000, China
Nanzhang People's Hospital
Xiangyang, Hubei, 441000, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441000, China
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, 441000, China
Xiangyang NO.1 People's Hospital
Xiangyang, Hubei, 441000, China
Xiangzhou People's Hospital
Xiangyang, Hubei, 441000, China
Yicheng People's Hosptital
Xiangyang, Hubei, 441000, China
Zaoyang NO.1 People's Hospital
Xiangyang, Hubei, 441000, China
Chibi General Hospital
Xianning, Hubei, 437000, China
Chongyang People's Hospital
Xianning, Hubei, 437000, China
Jiayu People's Hospital
Xianning, Hubei, 437000, China
The First People's Hospital of Xianning
Xianning, Hubei, 437000, China
TongchengPeople's Hospital
Xianning, Hubei, 437000, China
Tongshan People's Hospital
Xianning, Hubei, 437000, China
Xianning Central Hospital
Xianning, Hubei, 437000, China
AMHT Hubei Aerospace Hospital
Xiaogan, Hubei, 432000, China
Anlu Puai Hospital
Xiaogan, Hubei, 432000, China
Dawu County Hosptal of Traditional Chinese Medicine
Xiaogan, Hubei, 432000, China
Dawu People's Hospital
Xiaogan, Hubei, 432000, China
Hanchuan People's Hospital
Xiaogan, Hubei, 432000, China
The Central Hospital of Xiaogan
Xiaogan, Hubei, 432000, China
Xiaochang First People's Hospital
Xiaogan, Hubei, 432000, China
Xiaogan First People's Hospital
Xiaogan, Hubei, 432000, China
Xiaogan Hoospital of Chinese Medicine
Xiaogan, Hubei, 432000, China
Yingcheng People's Hospital
Xiaogan, Hubei, 432000, China
Yunmeng People's Hospital
Xiaogan, Hubei, 432000, China
Affiliated Renhe Hospital of China Three GORGES University
Yichang, Hubei, 443000, China
People's Hospital of Dangyang
Yichang, Hubei, 443000, China
People's Hospital of Zhijiang
Yichang, Hubei, 443000, China
People's Hospital of Zigui
Yichang, Hubei, 443000, China
Sinopharm Gezhouba Central Hospital
Yichang, Hubei, 443000, China
The First Hospital of YC
Yichang, Hubei, 443000, China
Yichang Central People's Hospital
Yichang, Hubei, 443000, China
Yichang Hospital of Traditional Chinese Medicine
Yichang, Hubei, 443000, China
Yichang Second People's Hospital
Yichang, Hubei, 443000, China
Yidu People's Hospital
Yichang, Hubei, 443000, China
Yiling Hospital of Yichang
Yichang, Hubei, 443000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Kai Huang, doctor
Union Hospital, Tongji Medical College of Huazhong University of science and technology
- STUDY CHAIR
Yong Huo, doctor
Peking University First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2023
First Posted
March 24, 2023
Study Start
January 15, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
December 15, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
The overall objective of the High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program will use Case Report Form scale, and data input and management were carried out by Electronic Data Capture System .