High Risk Population of Cardiovascular Disease in Hubei Province Screening and Intervention Program
- Conditions
- Cardiovascular DiseasesDiabetes Mellitus, Type 2Coronary Disease
- Interventions
- Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence
- Registration Number
- NCT05782881
- Lead Sponsor
- Wuhan Union Hospital, China
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16000
- 40-75 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Protocol treatment group phone calls and encouraging patients' lifestyle change and medication adherence Strictly intervene blood glucose, blood pressure and blood lipids Protocol treatment group Statin Strictly intervene blood glucose, blood pressure and blood lipids Conventional treatment group Statin Treatment and management according to the guidelines
- Primary Outcome Measures
Name Time Method 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 Record the composite cardiovascular disease(cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome)
- Secondary Outcome Measures
Name Time Method All-cause death 1 year after baseline Number of all-cause death
All-cause mortality 1 year after baseline Record all-cause mortality
Cardiovascular death 1 year after baseline Record cardiovascular death
non-fatal myocardial infarction 1 year after baseline Record non-fatal myocardial infarction
non-fatal stroke 1 year after baseline Record non-fatal stroke
readmission for heart failure 1 year after baseline Record readmission for heart failure
readmission for acute coronary syndrome 1 year after baseline Number of patients with readmission for acute coronary syndrome
Diabetic nephropathy 1 year after baseline Number of patients with Diabetic nephropathy
Proportion of hypertension control (BP<140/90 mm Hg) 1 year after baseline Record proportion of hypertension control (BP\<140/90 mm Hg)
Proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L) 1 year after baseline Record proportion of low density lipoprotein-cholesterol(LDL-C\<1.4mmol/L)
Proportion of glycosylated hemoglobin(GHb<7.0%) 1 year after baseline Record proportion of glycosylated hemoglobin(GHb\<7.0%)
Blood pressure( both diastolic and systolic will be measured) baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline Record blood pressure( both diastolic and systolic will be measured)
Trial Locations
- Locations (107)
Badong Peolple's Hospital
🇨🇳Enshi, Hubei, China
Enshi Central Hospital
🇨🇳Enshi, Hubei, China
Laifeng People's Hospital
🇨🇳Enshi, Hubei, China
Lichuan People's Hospital
🇨🇳Enshi, Hubei, China
The People's Hospital of Jianshi
🇨🇳Enshi, Hubei, China
Xianfeng County People's Hospital
🇨🇳Enshi, Hubei, China
Xuanen People's Hospital
🇨🇳Enshi, Hubei, China
Ezhou Central Hospital
🇨🇳Ezhou, Hubei, China
Ezhou Hospital of Chinese Medicine
🇨🇳Ezhou, Hubei, China
Hongan People's Hospital
🇨🇳Huanggang, Hubei, China
Luotian People's Hospital
🇨🇳Huanggang, Hubei, China
People's Hostpital of Macheng City
🇨🇳Huanggang, Hubei, China
Qichun People's Hospital
🇨🇳Huanggang, Hubei, China
The People's Hospital of Tuanfeng
🇨🇳Huanggang, Hubei, China
Wuxue People's Hopital
🇨🇳Huanggang, Hubei, China
Xishui People's Hospital
🇨🇳Huanggang, Hubei, China
Yingshan People's Hospital
🇨🇳Huanggang, Hubei, China
Daye People's Hospital
🇨🇳Huangshi, Hubei, China
Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic University
🇨🇳Huangshi, Hubei, China
Yangxin People's Hospital
🇨🇳Huangshi, Hubei, China
Jingmen NO.1 People's Hospital
🇨🇳Jingmen, Hubei, China
Zhongxiang Hospital of Traditional Chinese Medicine
🇨🇳Jingmen, Hubei, China
Zhongxiang People's Hospital
🇨🇳Jingmen, Hubei, China
Chinese Medicine Hospital of Gongan
🇨🇳Jingzhou, Hubei, China
Chinese Medicine Hospital of Honghu
🇨🇳Jingzhou, Hubei, China
Jiangling People's Hospital
🇨🇳Jingzhou, Hubei, China
Jianli People's Hospital
🇨🇳Jingzhou, Hubei, China
Jingzhou Central Hospital
🇨🇳Jingzhou, Hubei, China
Jingzhou Hospital of Traditional Chinese Medicine
🇨🇳Jingzhou, Hubei, China
Jingzhou No.1 People's Hospital
🇨🇳Jingzhou, Hubei, China
People's Hospital of Gongan
🇨🇳Jingzhou, Hubei, China
People's Hospital of Honghu
🇨🇳Jingzhou, Hubei, China
Shishou People's Hostpital
🇨🇳Jingzhou, Hubei, China
Songzi of Traditional Chinese Medicine
🇨🇳Jingzhou, Hubei, China
Songzi People's Hospital
🇨🇳Jingzhou, Hubei, China
The Second Hospital of Jingzhou
🇨🇳Jingzhou, Hubei, China
The Second People's Hospital of Jianli
🇨🇳Jingzhou, Hubei, China
Danjiangkou First Hospital
🇨🇳Shiyan, Hubei, China
Sinopharm Dongfeng General Hospital, Hubei University of Medicine
🇨🇳Shiyan, Hubei, China
Taihe Hospital
🇨🇳Shiyan, Hubei, China
Xunyang People's Hospital
🇨🇳Shiyan, Hubei, China
Yunxi People's Hospital
🇨🇳Shiyan, Hubei, China
Zhushan People's Hospital
🇨🇳Shiyan, Hubei, China
Zhuxi Hospital of Traditional Chinese Medicine
🇨🇳Shiyan, Hubei, China
People's Hospital of Suixian
🇨🇳Suizhou, Hubei, China
Suizhou Central Hospital
🇨🇳Suizhou, Hubei, China
Suizhou Hospital of Traditional Chinese Medicine
🇨🇳Suizhou, Hubei, China
The First People's Hospital of Tianmen in Hubei Province
🇨🇳Tianmen, Hubei, China
CR & WISCO General Hospital
🇨🇳Wuhan, Hubei, China
The Central Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
Union Hospital, Tongji Medical College of Huazhong University of science and technology
🇨🇳Wuhan, Hubei, China
Wuhan NO.1 Hospital
🇨🇳Wuhan, Hubei, China
Wuhan Third Hospital-Tongren Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
Huanggang Central Hospital
🇨🇳Wuhan, Hubei, China
Baokang People's Hospital
🇨🇳Xiangyang, Hubei, China
Gucheng People's Hospital
🇨🇳Xiangyang, Hubei, China
Laohekou NO.1 Hospital
🇨🇳Xiangyang, Hubei, China
Nanzhang People's Hospital
🇨🇳Xiangyang, Hubei, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
Xiangyang Hospital of Traditional Chinese Medicine
🇨🇳Xiangyang, Hubei, China
Yicheng People's Hosptital
🇨🇳Xiangyang, Hubei, China
Zaoyang NO.1 People's Hospital
🇨🇳Xiangyang, Hubei, China
Chongyang People's Hospital
🇨🇳Xianning, Hubei, China
TongchengPeople's Hospital
🇨🇳Xianning, Hubei, China
Tongshan People's Hospital
🇨🇳Xianning, Hubei, China
Hanchuan People's Hospital
🇨🇳Xiaogan, Hubei, China
Xiaochang First People's Hospital
🇨🇳Xiaogan, Hubei, China
Xiaogan Hoospital of Chinese Medicine
🇨🇳Xiaogan, Hubei, China
Affiliated Renhe Hospital of China Three GORGES University
🇨🇳Yichang, Hubei, China
People's Hospital of Zigui
🇨🇳Yichang, Hubei, China
Yichang Second People's Hospital
🇨🇳Yichang, Hubei, China
Affiliated Minzu University Hospital of Hubei Minzu University
🇨🇳Enshi, Hubei, China
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
🇨🇳Enshi, Hubei, China
Huangmei Peolple's Hospital
🇨🇳Huanggang, Hubei, China
Jingshan Union Hospital of Huazhong University of Science and Technology
🇨🇳Jingmen, Hubei, China
Huangshi Central Hospital
🇨🇳Huangshi, Hubei, China
Jingmen NO.2 People's Hospital
🇨🇳Jingmen, Hubei, China
Jianli Hospital of Chinese Medicine
🇨🇳Jingzhou, Hubei, China
Shiyan Renmin Hospital
🇨🇳Shiyan, Hubei, China
Fang County People's Hospital
🇨🇳Shiyan, Hubei, China
NO.1 Peoples Hospital of Guangshui
🇨🇳Suizhou, Hubei, China
Suizhou Zengdu Hospital
🇨🇳Suizhou, Hubei, China
People's Hospital of Dongxihu District
🇨🇳Wuhan, Hubei, China
Fifth Hospital in Wuhan
🇨🇳Wuhan, Hubei, China
Hospital of Universal Love
🇨🇳Wuhan, Hubei, China
Xiangzhou People's Hospital
🇨🇳Xiangyang, Hubei, China
Xiangyang NO.1 People's Hospital
🇨🇳Xiangyang, Hubei, China
Chibi General Hospital
🇨🇳Xianning, Hubei, China
Jiayu People's Hospital
🇨🇳Xianning, Hubei, China
The First People's Hospital of Xianning
🇨🇳Xianning, Hubei, China
Xianning Central Hospital
🇨🇳Xianning, Hubei, China
Anlu Puai Hospital
🇨🇳Xiaogan, Hubei, China
Dawu County Hosptal of Traditional Chinese Medicine
🇨🇳Xiaogan, Hubei, China
AMHT Hubei Aerospace Hospital
🇨🇳Xiaogan, Hubei, China
Dawu People's Hospital
🇨🇳Xiaogan, Hubei, China
The Central Hospital of Xiaogan
🇨🇳Xiaogan, Hubei, China
Xiaogan First People's Hospital
🇨🇳Xiaogan, Hubei, China
Yingcheng People's Hospital
🇨🇳Xiaogan, Hubei, China
People's Hospital of Zhijiang
🇨🇳Yichang, Hubei, China
Yunmeng People's Hospital
🇨🇳Xiaogan, Hubei, China
People's Hospital of Dangyang
🇨🇳Yichang, Hubei, China
Sinopharm Gezhouba Central Hospital
🇨🇳Yichang, Hubei, China
The First Hospital of YC
🇨🇳Yichang, Hubei, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
Yichang Hospital of Traditional Chinese Medicine
🇨🇳Yichang, Hubei, China
Yidu People's Hospital
🇨🇳Yichang, Hubei, China
Yiling Hospital of Yichang
🇨🇳Yichang, Hubei, China