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

Huazhong University of Science and Technology

Status: Enrolling

Conditions: Cardiovascular Diseases; Coronary Disease; Diabetes Mellitus, Type 2

Treatments: Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence; Drug: Statin

Study type: Interventional

Funder types: Other

Identifiers

NCT05782881

CCDInT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16,000 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16,000 participants in 2 patient groups, including a placebo group

Protocol treatment group

Experimental group

Description:

Strictly intervene blood glucose, blood pressure and blood lipids

Treatment:

Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence

Drug: Statin

Conventional treatment group

Placebo Comparator group

Description:

Treatment and management according to the guidelines

Treatment:

Drug: Statin