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

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Coronary Disease
• Interventions: Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence; Drug: Statin

• Registration Number: NCT05782881
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study Start: 2023-01-15
• Study First Submitted: 2023-02-18
• Study First Submitted QC: 2023-03-12
• Study First Posted: 2023-03-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-15
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol treatment group	phone calls and encouraging patients' lifestyle change and medication adherence	Strictly intervene blood glucose, blood pressure and blood lipids
Protocol treatment group	Statin	Strictly intervene blood glucose, blood pressure and blood lipids
Conventional treatment group	Statin	Treatment and management according to the guidelines

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All-cause death	1 year after baseline	Number of all-cause death
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
readmission for acute coronary syndrome	1 year after baseline	Number of patients with readmission for acute coronary syndrome
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)

Trial Locations

Locations (107)

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

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