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NCT05782881

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

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

Total Enrollment

16000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2024-12-31

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.

Conditions

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Cardiovascular Diseases Diabetes Mellitus, Type 2 Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Protocol treatment group

Strictly intervene blood glucose, blood pressure and blood lipids

Group Type EXPERIMENTAL

phone calls and encouraging patients' lifestyle change and medication adherence

Intervention Type BEHAVIORAL

Use some methods to strictly intervene blood glucose , blood pressure and blood lipids for protocol treatment group people.

Statin

Intervention Type DRUG

Treatment and management according to the guidelines

Conventional treatment group

Treatment and management according to the guidelines

Group Type PLACEBO_COMPARATOR

Statin

Intervention Type DRUG

Treatment and management according to the guidelines

Interventions

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phone 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.

Intervention Type BEHAVIORAL

Statin

Treatment and management according to the guidelines

Intervention Type DRUG

Other Intervention Names

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Angiotensin-converting enzyme inhibitor Angiotensin receptor neprilysin inhibitor Glucagon-like peptide-1 Sodium-dependent glucose transporters 2

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kai Huang, doctor

Role: STUDY_CHAIR

Union Hospital, Tongji Medical College of Huazhong University of science and technology

Yong Huo, doctor

Role: STUDY_CHAIR

Peking University First Hospital

Locations

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