Clinical trial NCT05782881: High Risk Population of Cardiovascular Disease in Hubei Province Screening and Intervention Program
Official title: High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Diabetes Mellitus, Type 2
Coronary Disease
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
First posted: 2023-03-24
Enrollment: 16000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite cardiovascular disease (cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome)
timeFrame: 1 year after baseline
Secondary outcomes:
measure: All-cause death
timeFrame: 1 year after baseline
measure: All-cause mortality
timeFrame: 1 year after baseline
measure: Cardiovascular death
timeFrame: 1 year after baseline
measure: non-fatal myocardial infarction
timeFrame: 1 year after baseline
measure: non-fatal stroke
timeFrame: 1 year after baseline
measure: readmission for heart failure
timeFrame: 1 year after baseline
measure: readmission for acute coronary syndrome
timeFrame: 1 year after baseline
measure: Diabetic nephropathy
timeFrame: 1 year after baseline
measure: Proportion of hypertension control (BP<140/90 mm Hg)
timeFrame: 1 year after baseline
measure: Proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L)
timeFrame: 1 year after baseline
measure: Proportion of glycosylated hemoglobin(GHb<7.0%)
timeFrame: 1 year after baseline
measure: Blood pressure( both diastolic and systolic will be measured)
timeFrame: baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Other outcomes:
Locations:
city: Enshi
country: China
facility: Affiliated Minzu University Hospital of Hubei Minzu University
state: Hubei
city: Enshi
country: China
facility: Badong Peolple's Hospital
state: Hubei
city: Enshi
country: China
facility: Enshi Central Hospital
state: Hubei
city: Enshi
country: China
facility: Laifeng People's Hospital
state: Hubei
city: Enshi
country: China
facility: Lichuan People's Hospital
state: Hubei
city: Enshi
country: China
facility: The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
state: Hubei
city: Enshi
country: China
facility: The People's Hospital of Jianshi
state: Hubei
city: Enshi
country: China
facility: Xianfeng County People's Hospital
state: Hubei
city: Enshi
country: China
facility: Xuanen People's Hospital
state: Hubei
city: Ezhou
country: China
facility: Ezhou Central Hospital
state: Hubei
city: Ezhou
country: China
facility: Ezhou Hospital of Chinese Medicine
state: Hubei
city: Huanggang
country: China
facility: Hongan People's Hospital
state: Hubei
city: Huanggang
country: China
facility: Huangmei Peolple's Hospital
state: Hubei
city: Huanggang
country: China
facility: Luotian People's Hospital
state: Hubei
city: Huanggang
country: China
facility: People's Hostpital of Macheng City
state: Hubei
city: Huanggang
country: China
facility: Qichun People's Hospital
state: Hubei
city: Huanggang
country: China
facility: The People's Hospital of Tuanfeng
state: Hubei
city: Huanggang
country: China
facility: Wuxue People's Hopital
state: Hubei
city: Huanggang
country: China
facility: Xishui People's Hospital
state: Hubei
city: Huanggang
country: China
facility: Yingshan People's Hospital
state: Hubei
city: Huangshi
country: China
facility: Daye People's Hospital
state: Hubei
city: Huangshi
country: China
facility: Huangshi Central Hospital
state: Hubei
city: Huangshi
country: China
facility: Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic University
state: Hubei
city: Huangshi
country: China
facility: Yangxin People's Hospital
state: Hubei
city: Jingmen
country: China
facility: Jingmen NO.1 People's Hospital
state: Hubei
city: Jingmen
country: China
facility: Jingmen NO.2 People's Hospital
state: Hubei
city: Jingmen
country: China
facility: Jingshan Union Hospital of Huazhong University of Science and Technology
state: Hubei
city: Jingmen
country: China
facility: Zhongxiang Hospital of Traditional Chinese Medicine
state: Hubei
city: Jingmen
country: China
facility: Zhongxiang People's Hospital
state: Hubei
city: Jingzhou
country: China
facility: Chinese Medicine Hospital of Gongan
state: Hubei
city: Jingzhou
country: China
facility: Chinese Medicine Hospital of Honghu
state: Hubei
city: Jingzhou
country: China
facility: Jiangling People's Hospital
state: Hubei
city: Jingzhou
country: China
facility: Jianli Hospital of Chinese Medicine
state: Hubei
city: Jingzhou
country: China
facility: Jianli People's Hospital
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou Hospital of Traditional Chinese Medicine
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou No.1 People's Hospital
state: Hubei
city: Jingzhou
country: China
facility: People's Hospital of Gongan
state: Hubei
city: Jingzhou
country: China
facility: People's Hospital of Honghu
state: Hubei
city: Jingzhou
country: China
facility: Shishou People's Hostpital
state: Hubei
city: Jingzhou
country: China
facility: Songzi of Traditional Chinese Medicine
state: Hubei
city: Jingzhou
country: China
facility: Songzi People's Hospital
state: Hubei
city: Jingzhou
country: China
facility: The Second Hospital of Jingzhou
state: Hubei
city: Jingzhou
country: China
facility: The Second People's Hospital of Jianli
state: Hubei
city: Shiyan
country: China
facility: Danjiangkou First Hospital
state: Hubei
city: Shiyan
country: China
facility: Fang County People's Hospital
state: Hubei
city: Shiyan
country: China
facility: Shiyan Renmin Hospital
state: Hubei
city: Shiyan
country: China
facility: Sinopharm Dongfeng General Hospital, Hubei University of Medicine
state: Hubei
city: Shiyan
country: China
facility: Taihe Hospital
state: Hubei
city: Shiyan
country: China
facility: Xunyang People's Hospital
state: Hubei
city: Shiyan
country: China
facility: Yunxi People's Hospital
state: Hubei
city: Shiyan
country: China
facility: Zhushan People's Hospital
state: Hubei
city: Shiyan
country: China
facility: Zhuxi Hospital of Traditional Chinese Medicine
state: Hubei
city: Suizhou
country: China
facility: NO.1 Peoples Hospital of Guangshui
state: Hubei
city: Suizhou
country: China
facility: People's Hospital of Suixian
state: Hubei
city: Suizhou
country: China
facility: Suizhou Central Hospital
state: Hubei
city: Suizhou
country: China
facility: Suizhou Hospital of Traditional Chinese Medicine
state: Hubei
city: Suizhou
country: China
facility: Suizhou Zengdu Hospital
state: Hubei
city: Tianmen
country: China
facility: The First People's Hospital of Tianmen in Hubei Province
state: Hubei
city: Wuhan
country: China
facility: CR & WISCO General Hospital
state: Hubei
city: Wuhan
country: China
facility: Fifth Hospital in Wuhan
state: Hubei
city: Wuhan
country: China
facility: Hospital of Universal Love
state: Hubei
city: Wuhan
country: China
facility: People's Hospital of Dongxihu District
state: Hubei
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College of Huazhong University of science and technology
state: Hubei
city: Wuhan
country: China
facility: Wuhan NO.1 Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Third Hospital-Tongren Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Huanggang Central Hospital
state: Hubei
city: Xiangyang
country: China
facility: Baokang People's Hospital
state: Hubei
city: Xiangyang
country: China
facility: Gucheng People's Hospital
state: Hubei
city: Xiangyang
country: China
facility: Laohekou NO.1 Hospital
state: Hubei
city: Xiangyang
country: China
facility: Nanzhang People's Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Hospital of Traditional Chinese Medicine
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang NO.1 People's Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangzhou People's Hospital
state: Hubei
city: Xiangyang
country: China
facility: Yicheng People's Hosptital
state: Hubei
city: Xiangyang
country: China
facility: Zaoyang NO.1 People's Hospital
state: Hubei
city: Xianning
country: China
facility: Chibi General Hospital
state: Hubei
city: Xianning
country: China
facility: Chongyang People's Hospital
state: Hubei
city: Xianning
country: China
facility: Jiayu People's Hospital
state: Hubei
city: Xianning
country: China
facility: The First People's Hospital of Xianning
state: Hubei
city: Xianning
country: China
facility: TongchengPeople's Hospital
state: Hubei
city: Xianning
country: China
facility: Tongshan People's Hospital
state: Hubei
city: Xianning
country: China
facility: Xianning Central Hospital
state: Hubei
city: Xiaogan
country: China
facility: AMHT Hubei Aerospace Hospital
state: Hubei
city: Xiaogan
country: China
facility: Anlu Puai Hospital
state: Hubei
city: Xiaogan
country: China
facility: Dawu County Hosptal of Traditional Chinese Medicine
state: Hubei
city: Xiaogan
country: China
facility: Dawu People's Hospital
state: Hubei
city: Xiaogan
country: China
facility: Hanchuan People's Hospital
state: Hubei
city: Xiaogan
country: China
facility: The Central Hospital of Xiaogan
state: Hubei
city: Xiaogan
country: China
facility: Xiaochang First People's Hospital
state: Hubei
city: Xiaogan
country: China
facility: Xiaogan First People's Hospital
state: Hubei
city: Xiaogan
country: China
facility: Xiaogan Hoospital of Chinese Medicine
state: Hubei
city: Xiaogan
country: China
facility: Yingcheng People's Hospital
state: Hubei
city: Xiaogan
country: China
facility: Yunmeng People's Hospital
state: Hubei
city: Yichang
country: China
facility: Affiliated Renhe Hospital of China Three GORGES University
state: Hubei
city: Yichang
country: China
facility: People's Hospital of Dangyang
state: Hubei
city: Yichang
country: China
facility: People's Hospital of Zhijiang
state: Hubei
city: Yichang
country: China
facility: People's Hospital of Zigui
state: Hubei
city: Yichang
country: China
facility: Sinopharm Gezhouba Central Hospital
state: Hubei
city: Yichang
country: China
facility: The First Hospital of YC
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Yichang
country: China
facility: Yichang Hospital of Traditional Chinese Medicine
state: Hubei
city: Yichang
country: China
facility: Yichang Second People's Hospital
state: Hubei
city: Yichang
country: China
facility: Yidu People's Hospital
state: Hubei
city: Yichang
country: China
facility: Yiling Hospital of Yichang
state: Hubei
Study officials:
affiliation: Union Hospital, Tongji Medical College of Huazhong University of science and technology
name: Kai Huang, doctor
role: STUDY_CHAIR
affiliation: Peking University First Hospital
name: Yong Huo, doctor
role: STUDY_CHAIR
References: