Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALphone 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.
DRUGStatin
Treatment and management according to the guidelines
Sponsors
Peking University First Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 1 year after baseline | Record all-cause mortality |
| Cardiovascular death | 1 year after baseline | Record cardiovascular death |
| non-fatal myocardial infarction | 1 year after baseline | Record non-fatal myocardial infarction |
| non-fatal stroke | 1 year after baseline | Record non-fatal stroke |
| readmission for heart failure | 1 year after baseline | Record readmission for heart failure |
| All-cause death | 1 year after baseline | Number of all-cause death |
| Diabetic nephropathy | 1 year after baseline | Number of patients with Diabetic nephropathy |
| Proportion of hypertension control (BP<140/90 mm Hg) | 1 year after baseline | Record proportion of hypertension control (BP\<140/90 mm Hg) |
| Proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L) | 1 year after baseline | Record proportion of low density lipoprotein-cholesterol(LDL-C\<1.4mmol/L) |
| Proportion of glycosylated hemoglobin(GHb<7.0%) | 1 year after baseline | Record proportion of glycosylated hemoglobin(GHb\<7.0%) |
| Blood pressure( both diastolic and systolic will be measured) | baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline | Record blood pressure( both diastolic and systolic will be measured) |
| readmission for acute coronary syndrome | 1 year after baseline | Number of patients with readmission for acute coronary syndrome |
Countries
China
Contacts
Primary ContactShan Deng, doctor
Outcome results
None listed