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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence
* Drug: Statin


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocol treatment group<br>Strictly intervene blood glucose, blood pressure and blood lipids | Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence<br>* Use some methods to strictly intervene blood glucose , blood pressure and blood lipids for protocol treatment group people.<br>Drug: Statin<br>* Treatment and management according to the guidelines<br>* Other names: Sodium-dependent glucose transporters 2;|
| Placebo Comparator: Conventional treatment group<br>Treatment and management according to the guidelines | Drug: Statin<br>* Treatment and management according to the guidelines<br>* Other names: Sodium-dependent glucose transporters 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | Number of all-cause death | 1 year after baseline | 
| All-cause mortality | Record all-cause mortality | 1 year after baseline | 
| Cardiovascular death | Record cardiovascular death | 1 year after baseline | 
| non-fatal myocardial infarction | Record non-fatal myocardial infarction | 1 year after baseline | 
| non-fatal stroke | Record non-fatal stroke | 1 year after baseline | 
| readmission for heart failure | Record readmission for heart failure | 1 year after baseline | 
| readmission for acute coronary syndrome | Number of patients with readmission for acute coronary syndrome | 1 year after baseline | 
| Diabetic nephropathy | Number of patients with Diabetic nephropathy | 1 year after baseline | 
| Proportion of hypertension control (BP<140/90 mm Hg) | Record proportion of hypertension control (BP<140/90 mm Hg) | 1 year after baseline | 
| 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 | 
| Proportion of glycosylated hemoglobin(GHb<7.0%) | Record proportion of glycosylated hemoglobin(GHb<7.0%) | 1 year after baseline | 
| 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 |