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

December 13, 2023 updated by: Wuhan Union Hospital, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

16000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • Affiliated Minzu University Hospital of Hubei Minzu University
        • Contact:
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • Badong Peolple's Hospital
        • Contact:
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • Enshi Central Hospital
        • Contact:
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • Laifeng People's Hospital
        • Contact:
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • Lichuan People's Hospital
        • Contact:
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
        • Contact:
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • The People's Hospital of Jianshi
        • Contact:
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • Xianfeng County People's Hospital
        • Contact:
      • Enshi, Hubei, China, 445000
        • Not yet recruiting
        • Xuanen People's Hospital
        • Contact:
      • Ezhou, Hubei, China, 436000
        • Not yet recruiting
        • Ezhou Central Hospital
        • Contact:
      • Ezhou, Hubei, China, 436000
        • Not yet recruiting
        • Ezhou Hospital of Chinese Medicine
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • Hongan People's Hospital
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • Huangmei Peolple's Hospital
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • Luotian People's Hospital
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • People's Hostpital of Macheng City
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • Qichun People's Hospital
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • The People's Hospital of Tuanfeng
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • Wuxue People's Hopital
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • Xishui People's Hospital
        • Contact:
      • Huanggang, Hubei, China, 438000
        • Not yet recruiting
        • Yingshan People's Hospital
        • Contact:
      • Huangshi, Hubei, China, 435000
        • Not yet recruiting
        • Daye People's Hospital
        • Contact:
      • Huangshi, Hubei, China, 435000
        • Not yet recruiting
        • Huangshi Central Hospital
        • Contact:
      • Huangshi, Hubei, China, 435000
        • Not yet recruiting
        • Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic University
        • Contact:
      • Huangshi, Hubei, China, 435000
        • Not yet recruiting
        • Yangxin People's Hospital
        • Contact:
      • Jingmen, Hubei, China, 448000
        • Not yet recruiting
        • Jingmen NO.1 People's Hospital
        • Contact:
      • Jingmen, Hubei, China, 448000
        • Not yet recruiting
        • Jingmen NO.2 People's Hospital
        • Contact:
      • Jingmen, Hubei, China, 448000
        • Not yet recruiting
        • Jingshan Union Hospital of Huazhong University of Science and Technology
        • Contact:
      • Jingmen, Hubei, China, 448000
        • Not yet recruiting
        • Zhongxiang Hospital of Traditional Chinese Medicine
        • Contact:
      • Jingmen, Hubei, China, 448000
        • Not yet recruiting
        • Zhongxiang People's Hospital
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Chinese Medicine Hospital of Gongan
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Chinese Medicine Hospital of Honghu
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Jiangling People's Hospital
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Jianli Hospital of Chinese Medicine
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Jianli People's Hospital
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Jingzhou Central Hospital
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Jingzhou Hospital of Traditional Chinese Medicine
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Jingzhou No.1 People's Hospital
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • People's Hospital of Gongan
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • People's Hospital of Honghu
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Shishou People's Hostpital
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Songzi of Traditional Chinese Medicine
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • Songzi People's Hospital
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • The Second Hospital of Jingzhou
        • Contact:
      • Jingzhou, Hubei, China, 434000
        • Not yet recruiting
        • The Second People's Hospital of Jianli
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Danjiangkou First Hospital
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Fang County People's Hospital
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Shiyan Renmin Hospital
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Sinopharm Dongfeng General Hospital, Hubei University of Medicine
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Taihe Hospital
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Xunyang People's Hospital
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Yunxi People's Hospital
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Zhushan People's Hospital
        • Contact:
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Zhuxi Hospital of Traditional Chinese Medicine
        • Contact:
      • Suizhou, Hubei, China, 441300
        • Not yet recruiting
        • NO.1 Peoples Hospital of Guangshui
        • Contact:
      • Suizhou, Hubei, China, 441300
        • Not yet recruiting
        • People's Hospital of Suixian
        • Contact:
      • Suizhou, Hubei, China, 441300
        • Not yet recruiting
        • Suizhou Central Hospital
        • Contact:
      • Suizhou, Hubei, China, 441300
        • Not yet recruiting
        • Suizhou Hospital of Traditional Chinese Medicine
        • Contact:
      • Suizhou, Hubei, China, 441300
        • Not yet recruiting
        • Suizhou Zengdu Hospital
        • Contact:
      • Tianmen, Hubei, China, 431700
        • Not yet recruiting
        • The First People's Hospital of Tianmen in Hubei Province
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • CR & WISCO General Hospital
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Fifth Hospital in Wuhan
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Hospital of Universal Love
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • People's Hospital of Dongxihu District
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • The Central Hospital of Wuhan
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital, Tongji Medical College of huazhong university of science and technology
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Wuhan No.1 hospital
        • Contact:
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Wuhan Third Hospital-Tongren Hospital Of Wuhan University
        • Contact:
      • Wuhan, Hubei, China, 438000
        • Not yet recruiting
        • Huanggang Central Hospital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Xiangyang Central Hospital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Baokang People's Hospital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Gucheng People's Hospital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Laohekou NO.1 Hospital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Nanzhang People's Hospital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Xiangyang Hospital of Traditional Chinese Medicine
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Xiangyang No.1 People's Hospital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Xiangzhou People's Hospital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Yicheng People's Hosptital
        • Contact:
      • Xiangyang, Hubei, China, 441000
        • Not yet recruiting
        • Zaoyang NO.1 People's Hospital
        • Contact:
      • Xianning, Hubei, China, 437000
        • Not yet recruiting
        • Chibi General Hospital
        • Contact:
      • Xianning, Hubei, China, 437000
        • Not yet recruiting
        • Chongyang People's Hospital
        • Contact:
      • Xianning, Hubei, China, 437000
        • Not yet recruiting
        • Jiayu People's Hospital
        • Contact:
      • Xianning, Hubei, China, 437000
        • Not yet recruiting
        • The First People's Hospital of Xianning
        • Contact:
      • Xianning, Hubei, China, 437000
        • Not yet recruiting
        • TongchengPeople's Hospital
        • Contact:
      • Xianning, Hubei, China, 437000
        • Not yet recruiting
        • Tongshan People's Hospital
        • Contact:
      • Xianning, Hubei, China, 437000
        • Not yet recruiting
        • Xianning Central Hospital
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • AMHT Hubei Aerospace Hospital
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Anlu Puai Hospital
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Dawu County Hosptal of Traditional Chinese Medicine
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Dawu People's Hospital
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Hanchuan People's Hospital
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • The Central Hospital of Xiaogan
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Xiaochang First People's Hospital
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Xiaogan First People's Hospital
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Xiaogan Hoospital of Chinese Medicine
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Yingcheng People's Hospital
        • Contact:
      • Xiaogan, Hubei, China, 432000
        • Not yet recruiting
        • Yunmeng People's Hospital
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • Affiliated Renhe Hospital of China Three GORGES University
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • People's Hospital of Dangyang
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • People's Hospital of Zhijiang
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • People's Hospital of Zigui
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • Sinopharm Gezhouba Central Hospital
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • The First Hospital of YC
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • Yichang Central People's Hospital
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • Yichang Hospital of Traditional Chinese Medicine
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • Yichang Second People's Hospital
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • Yidu People's Hospital
        • Contact:
      • Yichang, Hubei, China, 443000
        • Not yet recruiting
        • Yiling Hospital of Yichang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protocol treatment group
Strictly intervene blood glucose, blood pressure and blood lipids
Behavioral: 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.
Drug: Statin
Treatment and management according to the guidelines
Other Names:
  • Glucagon-like peptide-1
  • Angiotensin-converting enzyme inhibitor
  • Angiotensin receptor neprilysin inhibitor
  • Sodium-dependent glucose transporters 2
Placebo Comparator: Conventional treatment group
Treatment and management according to the guidelines
Drug: Statin
Treatment and management according to the guidelines
Other Names:
  • Glucagon-like peptide-1
  • Angiotensin-converting enzyme inhibitor
  • Angiotensin receptor neprilysin inhibitor
  • Sodium-dependent glucose transporters 2

What is the study measuring?

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)
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)
1 year after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: 1 year after baseline
Number of all-cause death
1 year after baseline
All-cause mortality
Time Frame: 1 year after baseline
Record all-cause mortality
1 year after baseline
Cardiovascular death
Time Frame: 1 year after baseline
Record cardiovascular death
1 year after baseline
non-fatal myocardial infarction
Time Frame: 1 year after baseline
Record non-fatal myocardial infarction
1 year after baseline
non-fatal stroke
Time Frame: 1 year after baseline
Record non-fatal stroke
1 year after baseline
readmission for heart failure
Time Frame: 1 year after baseline
Record readmission for heart failure
1 year after baseline
readmission for acute coronary syndrome
Time Frame: 1 year after baseline
Number of patients with readmission for acute coronary syndrome
1 year after baseline
Diabetic nephropathy
Time Frame: 1 year after baseline
Number of patients with Diabetic nephropathy
1 year after baseline
Proportion of hypertension control (BP<140/90 mm Hg)
Time Frame: 1 year after baseline
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)
Time Frame: 1 year after baseline
Record proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L)
1 year after baseline
Proportion of glycosylated hemoglobin(GHb<7.0%)
Time Frame: 1 year after baseline
Record proportion of glycosylated hemoglobin(GHb<7.0%)
1 year after baseline
Blood pressure( both diastolic and systolic will be measured)
Time Frame: baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Record blood pressure( both diastolic and systolic will be measured)
baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Collaborators

Peking University First Hospital

Investigators

  • Study Chair: Kai Huang, doctor, Union Hospital, Tongji Medical College of huazhong university of science and technology
  • Study Chair: Yong Huo, doctor, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCDInT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The overall objective of the High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program will use Case Report Form scale, and data input and management were carried out by Electronic Data Capture System .

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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