High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program
| Registry | NCT05782881 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 16000 (Estimated) |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Other); collaborators: Peking University First Hospital |
| Conditions | Cardiovascular Diseases, Diabetes Mellitus, Type 2, Coronary Disease |
| Interventions | phone calls and encouraging patients' lifestyle change and medication adherence, Statin (Behavioral, drug) |
| Dates | start 2023-01-15, primary completion 2023-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2023-03-24, last updated 2023-12-15 |
| Locations | 107 sites in China |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Cardiovascular Diseases All trials for Diabetes Mellitus, Type 2 All trials of phone calls and encouraging patients' lifestyle change and medication adherence All trials of Statin
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.
The overall objective of the High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program(CCDInT) will be carried out in medical institutions in 14 prefecture level cities (prefectures) in Hubei province that could meet the test requirements. A total of 16,000 individuals aged ≥40 years with coronary heart disease with diabetes will be recruited into the study. Study participants will be followed in 1 year for some study outcomes. The main purpose of this study is to verify that the 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. In addition, the investigators will further study the genetic mechanism of compound cardiovascular events from the molecular genetic level, and explore the contribution and impact of genetic diversity on the treatment effect. At the same time, explore and establish a cardiovascular disease prevention and control system and effective mechanism under the leadership of provincial and municipal health administrative departments, organized by provincial prevention and control centers, and guided by municipal and state prevention and control centers, which provide theoretical and experimental basis for formulating strategies for large-scale intervention of related diseases, so as to improve the prevention and control status and effect, and strive to reduce the disease and social burden.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Protocol treatment group | Experimental | Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence; Drug: Statin | Strictly intervene blood glucose, blood pressure and blood lipids |
| Conventional treatment group | Placebo comparator | Drug: Statin | Treatment and management according to the guidelines |
Sex: All, ages: 40 Years to 75 Years
Inclusion Criteria: 1. 40-75 years old, male or female 2. Patients with coronary heart disease complicated with type 2 diabetes (confirmed by angiography) 3. Low density lipoprotein cholesterol >1.8mmol/l 4. Willing to participate and sign informed consent Exclusion Criteria: 1. Received coronary stent treatment in recent one year 2. Pregnant or lactating women 3. Decompensated stage of chronic systolic heart failure (NYHA cardiac function rating ≥ 3), cardiac function; Patients with severe cardiovascular complications such as septic shock 4. Stroke patients in recent 1 year 5. Patients with severe gastrointestinal diseases, liver failure or kidney failure 6. Cancer patients or patients who have received radiotherapy or chemotherapy within five years 7. Suffering from infectious diseases such as AIDS and tuberculosis 8. Hospitalized or suffering from other serious diseases requiring immediate hospitalization 9. Bad addicts: drug users or alcoholics (men >80 g / day, women >40 g / day) 10. Disturbance of consciousness, inability to communicate normally or any mental illness; Those who are inconvenient to take care of themselves or move 11. Life expectancy <12 months 12. Individuals with abnormal laboratory tests and clinical manifestations who are judged by the researcher to be unsuitable for participation 13. Unwilling to participate in the trial, unwilling to change the current drug treatment plan
| Facility | City | Country | Status |
|---|---|---|---|
| Affiliated Minzu University Hospital of Hubei Minzu University | Enshi, Hubei | China | Not yet recruiting |
| Badong Peolple's Hospital | Enshi, Hubei | China | Not yet recruiting |
| Enshi Central Hospital | Enshi, Hubei | China | Not yet recruiting |
| Laifeng People's Hospital | Enshi, Hubei | China | Not yet recruiting |
| Lichuan People's Hospital | Enshi, Hubei | China | Not yet recruiting |
| The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture | Enshi, Hubei | China | Not yet recruiting |
| The People's Hospital of Jianshi | Enshi, Hubei | China | Not yet recruiting |
| Xianfeng County People's Hospital | Enshi, Hubei | China | Not yet recruiting |
| Xuanen People's Hospital | Enshi, Hubei | China | Not yet recruiting |
| Ezhou Central Hospital | Ezhou, Hubei | China | Not yet recruiting |
| Ezhou Hospital of Chinese Medicine | Ezhou, Hubei | China | Not yet recruiting |
| Hongan People's Hospital | Huanggang, Hubei | China | Not yet recruiting |
| Huangmei Peolple's Hospital | Huanggang, Hubei | China | Not yet recruiting |
| Luotian People's Hospital | Huanggang, Hubei | China | Not yet recruiting |
| People's Hostpital of Macheng City | Huanggang, Hubei | China | Not yet recruiting |
| Qichun People's Hospital | Huanggang, Hubei | China | Not yet recruiting |
| The People's Hospital of Tuanfeng | Huanggang, Hubei | China | Not yet recruiting |
| Wuxue People's Hopital | Huanggang, Hubei | China | Not yet recruiting |
| Xishui People's Hospital | Huanggang, Hubei | China | Not yet recruiting |
| Yingshan People's Hospital | Huanggang, Hubei | China | Not yet recruiting |
| Daye People's Hospital | Huangshi, Hubei | China | Not yet recruiting |
| Huangshi Central Hospital | Huangshi, Hubei | China | Not yet recruiting |
| Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic University | Huangshi, Hubei | China | Not yet recruiting |
| Yangxin People's Hospital | Huangshi, Hubei | China | Not yet recruiting |
| Jingmen NO.1 People's Hospital | Jingmen, Hubei | China | Not yet recruiting |
| Jingmen NO.2 People's Hospital | Jingmen, Hubei | China | Not yet recruiting |
| Jingshan Union Hospital of Huazhong University of Science and Technology | Jingmen, Hubei | China | Not yet recruiting |
| Zhongxiang Hospital of Traditional Chinese Medicine | Jingmen, Hubei | China | Not yet recruiting |
| Zhongxiang People's Hospital | Jingmen, Hubei | China | Not yet recruiting |
| Chinese Medicine Hospital of Gongan | Jingzhou, Hubei | China | Not yet recruiting |
| Chinese Medicine Hospital of Honghu | Jingzhou, Hubei | China | Not yet recruiting |
| Jiangling People's Hospital | Jingzhou, Hubei | China | Not yet recruiting |
| Jianli Hospital of Chinese Medicine | Jingzhou, Hubei | China | Not yet recruiting |
| Jianli People's Hospital | Jingzhou, Hubei | China | Not yet recruiting |
| Jingzhou Central Hospital | Jingzhou, Hubei | China | Not yet recruiting |
| Jingzhou Hospital of Traditional Chinese Medicine | Jingzhou, Hubei | China | Not yet recruiting |
| Jingzhou No.1 People's Hospital | Jingzhou, Hubei | China | Not yet recruiting |
| People's Hospital of Gongan | Jingzhou, Hubei | China | Not yet recruiting |
| People's Hospital of Honghu | Jingzhou, Hubei | China | Not yet recruiting |
| Shishou People's Hostpital | Jingzhou, Hubei | China | Not yet recruiting |
| Songzi of Traditional Chinese Medicine | Jingzhou, Hubei | China | Not yet recruiting |
| Songzi People's Hospital | Jingzhou, Hubei | China | Not yet recruiting |
| The Second Hospital of Jingzhou | Jingzhou, Hubei | China | Not yet recruiting |
| The Second People's Hospital of Jianli | Jingzhou, Hubei | China | Not yet recruiting |
| Danjiangkou First Hospital | Shiyan, Hubei | China | Not yet recruiting |
| Fang County People's Hospital | Shiyan, Hubei | China | Not yet recruiting |
| Shiyan Renmin Hospital | Shiyan, Hubei | China | Not yet recruiting |
| Sinopharm Dongfeng General Hospital, Hubei University of Medicine | Shiyan, Hubei | China | Not yet recruiting |
| Taihe Hospital | Shiyan, Hubei | China | Not yet recruiting |
| Xunyang People's Hospital | Shiyan, Hubei | China | Not yet recruiting |
| Yunxi People's Hospital | Shiyan, Hubei | China | Not yet recruiting |
| Zhushan People's Hospital | Shiyan, Hubei | China | Not yet recruiting |
| Zhuxi Hospital of Traditional Chinese Medicine | Shiyan, Hubei | China | Not yet recruiting |
| NO.1 Peoples Hospital of Guangshui | Suizhou, Hubei | China | Not yet recruiting |
| People's Hospital of Suixian | Suizhou, Hubei | China | Not yet recruiting |
| Suizhou Central Hospital | Suizhou, Hubei | China | Not yet recruiting |
| Suizhou Hospital of Traditional Chinese Medicine | Suizhou, Hubei | China | Not yet recruiting |
| Suizhou Zengdu Hospital | Suizhou, Hubei | China | Not yet recruiting |
| The First People's Hospital of Tianmen in Hubei Province | Tianmen, Hubei | China | Not yet recruiting |
| CR & WISCO General Hospital | Wuhan, Hubei | China | Not yet recruiting |
| Fifth Hospital in Wuhan | Wuhan, Hubei | China | Not yet recruiting |
| Hospital of Universal Love | Wuhan, Hubei | China | Not yet recruiting |
| People's Hospital of Dongxihu District | Wuhan, Hubei | China | Not yet recruiting |
| The Central Hospital of Wuhan | Wuhan, Hubei | China | Not yet recruiting |
| Union Hospital, Tongji Medical College of Huazhong University of science and technology | Wuhan, Hubei | China | Recruiting |
| Wuhan NO.1 Hospital | Wuhan, Hubei | China | Not yet recruiting |
| Wuhan Third Hospital-Tongren Hospital of Wuhan University | Wuhan, Hubei | China | Not yet recruiting |
| Huanggang Central Hospital | Wuhan, Hubei | China | Not yet recruiting |
| Baokang People's Hospital | Xiangyang, Hubei | China | Not yet recruiting |
| Gucheng People's Hospital | Xiangyang, Hubei | China | Not yet recruiting |
| Laohekou NO.1 Hospital | Xiangyang, Hubei | China | Not yet recruiting |
| Nanzhang People's Hospital | Xiangyang, Hubei | China | Not yet recruiting |
| Xiangyang Central Hospital | Xiangyang, Hubei | China | Not yet recruiting |
| Xiangyang Hospital of Traditional Chinese Medicine | Xiangyang, Hubei | China | Not yet recruiting |
| Xiangyang NO.1 People's Hospital | Xiangyang, Hubei | China | Not yet recruiting |
| Xiangzhou People's Hospital | Xiangyang, Hubei | China | Not yet recruiting |
| Yicheng People's Hosptital | Xiangyang, Hubei | China | Not yet recruiting |
| Zaoyang NO.1 People's Hospital | Xiangyang, Hubei | China | Not yet recruiting |
| Chibi General Hospital | Xianning, Hubei | China | Not yet recruiting |
| Chongyang People's Hospital | Xianning, Hubei | China | Not yet recruiting |
| Jiayu People's Hospital | Xianning, Hubei | China | Not yet recruiting |
| The First People's Hospital of Xianning | Xianning, Hubei | China | Not yet recruiting |
| TongchengPeople's Hospital | Xianning, Hubei | China | Not yet recruiting |
| Tongshan People's Hospital | Xianning, Hubei | China | Not yet recruiting |
| Xianning Central Hospital | Xianning, Hubei | China | Not yet recruiting |
| AMHT Hubei Aerospace Hospital | Xiaogan, Hubei | China | Not yet recruiting |
| Anlu Puai Hospital | Xiaogan, Hubei | China | Not yet recruiting |
| Dawu County Hosptal of Traditional Chinese Medicine | Xiaogan, Hubei | China | Not yet recruiting |
| Dawu People's Hospital | Xiaogan, Hubei | China | Not yet recruiting |
| Hanchuan People's Hospital | Xiaogan, Hubei | China | Not yet recruiting |
| The Central Hospital of Xiaogan | Xiaogan, Hubei | China | Not yet recruiting |
| Xiaochang First People's Hospital | Xiaogan, Hubei | China | Not yet recruiting |
| Xiaogan First People's Hospital | Xiaogan, Hubei | China | Not yet recruiting |
| Xiaogan Hoospital of Chinese Medicine | Xiaogan, Hubei | China | Not yet recruiting |
| Yingcheng People's Hospital | Xiaogan, Hubei | China | Not yet recruiting |
| Yunmeng People's Hospital | Xiaogan, Hubei | China | Not yet recruiting |
| Affiliated Renhe Hospital of China Three GORGES University | Yichang, Hubei | China | Not yet recruiting |
| People's Hospital of Dangyang | Yichang, Hubei | China | Not yet recruiting |
| People's Hospital of Zhijiang | Yichang, Hubei | China | Not yet recruiting |
| People's Hospital of Zigui | Yichang, Hubei | China | Not yet recruiting |
7 more sites not listed.