High Risk Population of Cardiovascular Disease in Hubei Province Screening and Intervention Program

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782881
• Other study ID #: CCDInT
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Wuhan Union Hospital, China
• Contact: Shan Deng, doctor
• Phone: 18120556507
• Email: dengshan1020[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 16000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Disease
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• phone calls and encouraging patients' lifestyle change and medication adherence
Use some methods to strictly intervene blood glucose , blood pressure and blood lipids for protocol treatment group people.

Drug:
• Statin
Treatment and management according to the guidelines

Locations

Country	Name	City	State
China	Affiliated Minzu University Hospital of Hubei Minzu University	Enshi	Hubei
China	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 Central Hospital of Enshi Tujia and Miao Autonomous Prefecture	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	Huangmei Peolple'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 Central 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	Jingmen NO.2 People's Hospital	Jingmen	Hubei
China	Jingshan Union Hospital of Huazhong University of Science and Technology	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 Hospital of Chinese Medicine	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	Fang County People's Hospital	Shiyan	Hubei
China	Shiyan Renmin 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	NO.1 Peoples Hospital of Guangshui	Suizhou	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	Suizhou Zengdu Hospital	Suizhou	Hubei
China	The First People's Hospital of Tianmen in Hubei Province	Tianmen	Hubei
China	CR & WISCO General Hospital	Wuhan	Hubei
China	Fifth Hospital in Wuhan	Wuhan	Hubei
China	Hospital of Universal Love	Wuhan	Hubei
China	Huanggang Central Hospital	Wuhan	Hubei
China	People's Hospital of Dongxihu District	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	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	Xiangyang NO.1 People's Hospital	Xiangyang	Hubei
China	Xiangzhou People's Hospital	Xiangyang	Hubei
China	Yicheng People's Hosptital	Xiangyang	Hubei
China	Zaoyang NO.1 People's Hospital	Xiangyang	Hubei
China	Chibi General Hospital	Xianning	Hubei
China	Chongyang People's Hospital	Xianning	Hubei
China	Jiayu People's Hospital	Xianning	Hubei
China	The First People's Hospital of Xianning	Xianning	Hubei
China	TongchengPeople's Hospital	Xianning	Hubei
China	Tongshan People's Hospital	Xianning	Hubei
China	Xianning Central Hospital	Xianning	Hubei
China	AMHT Hubei Aerospace Hospital	Xiaogan	Hubei
China	Anlu Puai Hospital	Xiaogan	Hubei
China	Dawu County Hosptal of Traditional Chinese Medicine	Xiaogan	Hubei
China	Dawu People's Hospital	Xiaogan	Hubei
China	Hanchuan People's Hospital	Xiaogan	Hubei
China	The Central Hospital of Xiaogan	Xiaogan	Hubei
China	Xiaochang First People's Hospital	Xiaogan	Hubei
China	Xiaogan First People's Hospital	Xiaogan	Hubei
China	Xiaogan Hoospital of Chinese Medicine	Xiaogan	Hubei
China	Yingcheng People's Hospital	Xiaogan	Hubei
China	Yunmeng People's Hospital	Xiaogan	Hubei
China	Affiliated Renhe Hospital of China Three GORGES University	Yichang	Hubei
China	People's Hospital of Dangyang	Yichang	Hubei
China	People's Hospital of Zhijiang	Yichang	Hubei
China	People's Hospital of Zigui	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	Yichang Second People's Hospital	Yichang	Hubei
China	Yidu People's Hospital	Yichang	Hubei
China	Yiling Hospital of Yichang	Yichang	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China	Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause death	Number of all-cause death	1 year after baseline
Secondary	All-cause mortality	Record all-cause mortality	1 year after baseline
Secondary	Cardiovascular death	Record cardiovascular death	1 year after baseline
Secondary	non-fatal myocardial infarction	Record non-fatal myocardial infarction	1 year after baseline
Secondary	non-fatal stroke	Record non-fatal stroke	1 year after baseline
Secondary	readmission for heart failure	Record readmission for heart failure	1 year after baseline
Secondary	readmission for acute coronary syndrome	Number of patients with readmission for acute coronary syndrome	1 year after baseline
Secondary	Diabetic nephropathy	Number of patients with Diabetic nephropathy	1 year after baseline
Secondary	Proportion of hypertension control (BP<140/90 mm Hg)	Record proportion of hypertension control (BP<140/90 mm Hg)	1 year after baseline
Secondary	Proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L)	Record proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L)	1 year after baseline
Secondary	Proportion of glycosylated hemoglobin(GHb<7.0%)	Record proportion of glycosylated hemoglobin(GHb<7.0%)	1 year after baseline
Secondary	Blood pressure( both diastolic and systolic will be measured)	Record blood pressure( both diastolic and systolic will be measured)	baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline