High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program
Overview
- Phase
- Not Applicable
- Intervention
- phone calls and encouraging patients' lifestyle change and medication adherence
- Conditions
- Cardiovascular Diseases
- Sponsor
- Wuhan Union Hospital, China
- Enrollment
- 16000
- Locations
- 107
- Primary Endpoint
- Composite cardiovascular disease (cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Protocol treatment group
Strictly intervene blood glucose, blood pressure and blood lipids
Intervention: phone calls and encouraging patients' lifestyle change and medication adherence
Protocol treatment group
Strictly intervene blood glucose, blood pressure and blood lipids
Intervention: Statin
Conventional treatment group
Treatment and management according to the guidelines
Intervention: Statin
Outcomes
Primary Outcomes
Composite cardiovascular disease (cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome)
Time Frame: 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 Outcomes
- All-cause death(1 year after baseline)
- All-cause mortality(1 year after baseline)
- Cardiovascular death(1 year after baseline)
- non-fatal myocardial infarction(1 year after baseline)
- non-fatal stroke(1 year after baseline)
- readmission for heart failure(1 year after baseline)
- readmission for acute coronary syndrome(1 year after baseline)
- Diabetic nephropathy(1 year after baseline)
- Proportion of hypertension control (BP<140/90 mm Hg)(1 year after baseline)
- Proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L)(1 year after baseline)
- Proportion of glycosylated hemoglobin(GHb<7.0%)(1 year after baseline)
- Blood pressure( both diastolic and systolic will be measured)(baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline)