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

Sponsor
Wuhan Union Hospital, China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05782881
Collaborator
Peking University First Hospital (Other)
16,000
Enrollment
107
Locations
2
Arms
21.6
Anticipated Duration (Months)
149.5
Patients Per Site
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence
  • Drug: Statin
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
16000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program
Anticipated Study Start Date :
Mar 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. All-cause death [1 year after baseline]

      Number of all-cause death

    2. All-cause mortality [1 year after baseline]

      Record all-cause mortality

    3. Cardiovascular death [1 year after baseline]

      Record cardiovascular death

    4. non-fatal myocardial infarction [1 year after baseline]

      Record non-fatal myocardial infarction

    5. non-fatal stroke [1 year after baseline]

      Record non-fatal stroke

    6. readmission for heart failure [1 year after baseline]

      Record readmission for heart failure

    7. readmission for acute coronary syndrome [1 year after baseline]

      Number of patients with readmission for acute coronary syndrome

    8. Diabetic nephropathy [1 year after baseline]

      Number of patients with Diabetic nephropathy

    9. Proportion of hypertension control (BP<140/90 mm Hg) [1 year after baseline]

      Record proportion of hypertension control (BP<140/90 mm Hg)

    10. 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)

    11. Proportion of glycosylated hemoglobin(GHb<7.0%) [1 year after baseline]

      Record proportion of glycosylated hemoglobin(GHb<7.0%)

    12. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affiliated Minzu University Hospital of Hubei Minzu University Enshi Hubei China 445000
    2 Badong Peolple's Hospital Enshi Hubei China 445000
    3 Enshi Central Hospital Enshi Hubei China 445000
    4 Laifeng People's Hospital Enshi Hubei China 445000
    5 Lichuan People's Hospital Enshi Hubei China 445000
    6 The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture Enshi Hubei China 445000
    7 The People's Hospital of Jianshi Enshi Hubei China 445000
    8 Xianfeng County People's Hospital Enshi Hubei China 445000
    9 Xuanen People's Hospital Enshi Hubei China 445000
    10 Ezhou Central Hospital Ezhou Hubei China 436000
    11 Ezhou Hospital of Chinese Medicine Ezhou Hubei China 436000
    12 Hongan People's Hospital Huanggang Hubei China 438000
    13 Huangmei Peolple's Hospital Huanggang Hubei China 438000
    14 Luotian People's Hospital Huanggang Hubei China 438000
    15 People's Hostpital of Macheng City Huanggang Hubei China 438000
    16 Qichun People's Hospital Huanggang Hubei China 438000
    17 The People's Hospital of Tuanfeng Huanggang Hubei China 438000
    18 Wuxue People's Hopital Huanggang Hubei China 438000
    19 Xishui People's Hospital Huanggang Hubei China 438000
    20 Yingshan People's Hospital Huanggang Hubei China 438000
    21 Daye People's Hospital Huangshi Hubei China 435000
    22 Huangshi Central Hospital Huangshi Hubei China 435000
    23 Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic University Huangshi Hubei China 435000
    24 Yangxin People's Hospital Huangshi Hubei China 435000
    25 Jingmen NO.1 People's Hospital Jingmen Hubei China 448000
    26 Jingmen NO.2 People's Hospital Jingmen Hubei China 448000
    27 Jingshan Union Hospital of Huazhong University of Science and Technology Jingmen Hubei China 448000
    28 Zhongxiang Hospital of Traditional Chinese Medicine Jingmen Hubei China 448000
    29 Zhongxiang People's Hospital Jingmen Hubei China 448000
    30 Chinese Medicine Hospital of Gongan Jingzhou Hubei China 434000
    31 Chinese Medicine Hospital of Honghu Jingzhou Hubei China 434000
    32 Jiangling People's Hospital Jingzhou Hubei China 434000
    33 Jianli Hospital of Chinese Medicine Jingzhou Hubei China 434000
    34 Jianli People's Hospital Jingzhou Hubei China 434000
    35 Jingzhou Central Hospital Jingzhou Hubei China 434000
    36 Jingzhou Hospital of Traditional Chinese Medicine Jingzhou Hubei China 434000
    37 Jingzhou No.1 People's Hospital Jingzhou Hubei China 434000
    38 People's Hospital of Gongan Jingzhou Hubei China 434000
    39 People's Hospital of Honghu Jingzhou Hubei China 434000
    40 Shishou People's Hostpital Jingzhou Hubei China 434000
    41 Songzi of Traditional Chinese Medicine Jingzhou Hubei China 434000
    42 Songzi People's Hospital Jingzhou Hubei China 434000
    43 The Second Hospital of Jingzhou Jingzhou Hubei China 434000
    44 The Second People's Hospital of Jianli Jingzhou Hubei China 434000
    45 Danjiangkou First Hospital Shiyan Hubei China 442000
    46 Fang County People's Hospital Shiyan Hubei China 442000
    47 Shiyan Renmin Hospital Shiyan Hubei China 442000
    48 Sinopharm Dongfeng General Hospital, Hubei University of Medicine Shiyan Hubei China 442000
    49 Taihe Hospital Shiyan Hubei China 442000
    50 Xunyang People's Hospital Shiyan Hubei China 442000
    51 Yunxi People's Hospital Shiyan Hubei China 442000
    52 Zhushan People's Hospital Shiyan Hubei China 442000
    53 Zhuxi Hospital of Traditional Chinese Medicine Shiyan Hubei China 442000
    54 NO.1 Peoples Hospital of Guangshui Suizhou Hubei China 441300
    55 People's Hospital of Suixian Suizhou Hubei China 441300
    56 Suizhou Central Hospital Suizhou Hubei China 441300
    57 Suizhou Hospital of Traditional Chinese Medicine Suizhou Hubei China 441300
    58 Suizhou Zengdu Hospital Suizhou Hubei China 441300
    59 The First People's Hospital of Tianmen in Hubei Province Tianmen Hubei China 431700
    60 CR & WISCO General Hospital Wuhan Hubei China 430000
    61 Fifth Hospital in Wuhan Wuhan Hubei China 430000
    62 Hospital of Universal Love Wuhan Hubei China 430000
    63 People's Hospital of Dongxihu District Wuhan Hubei China 430000
    64 The Central Hospital of Wuhan Wuhan Hubei China 430000
    65 Union Hospital, Tongji Medical College of Huazhong University of science and technology Wuhan Hubei China 430000
    66 Wuhan NO.1 Hospital Wuhan Hubei China 430000
    67 Wuhan Third Hospital-Tongren Hospital of Wuhan University Wuhan Hubei China 430000
    68 Huanggang Central Hospital Wuhan Hubei China 438000
    69 Baokang People's Hospital Xiangyang Hubei China 441000
    70 Gucheng People's Hospital Xiangyang Hubei China 441000
    71 Laohekou NO.1 Hospital Xiangyang Hubei China 441000
    72 Nanzhang People's Hospital Xiangyang Hubei China 441000
    73 Xiangyang Central Hospital Xiangyang Hubei China 441000
    74 Xiangyang Hospital of Traditional Chinese Medicine Xiangyang Hubei China 441000
    75 Xiangyang NO.1 People's Hospital Xiangyang Hubei China 441000
    76 Xiangzhou People's Hospital Xiangyang Hubei China 441000
    77 Yicheng People's Hosptital Xiangyang Hubei China 441000
    78 Zaoyang NO.1 People's Hospital Xiangyang Hubei China 441000
    79 Chibi General Hospital Xianning Hubei China 437000
    80 Chongyang People's Hospital Xianning Hubei China 437000
    81 Jiayu People's Hospital Xianning Hubei China 437000
    82 The First People's Hospital of Xianning Xianning Hubei China 437000
    83 TongchengPeople's Hospital Xianning Hubei China 437000
    84 Tongshan People's Hospital Xianning Hubei China 437000
    85 Xianning Central Hospital Xianning Hubei China 437000
    86 AMHT Hubei Aerospace Hospital Xiaogan Hubei China 432000
    87 Anlu Puai Hospital Xiaogan Hubei China 432000
    88 Dawu County Hosptal of Traditional Chinese Medicine Xiaogan Hubei China 432000
    89 Dawu People's Hospital Xiaogan Hubei China 432000
    90 Hanchuan People's Hospital Xiaogan Hubei China 432000
    91 The Central Hospital of Xiaogan Xiaogan Hubei China 432000
    92 Xiaochang First People's Hospital Xiaogan Hubei China 432000
    93 Xiaogan First People's Hospital Xiaogan Hubei China 432000
    94 Xiaogan Hoospital of Chinese Medicine Xiaogan Hubei China 432000
    95 Yingcheng People's Hospital Xiaogan Hubei China 432000
    96 Yunmeng People's Hospital Xiaogan Hubei China 432000
    97 Affiliated Renhe Hospital of China Three GORGES University Yichang Hubei China 443000
    98 People's Hospital of Dangyang Yichang Hubei China 443000
    99 People's Hospital of Zhijiang Yichang Hubei China 443000
    100 People's Hospital of Zigui Yichang Hubei China 443000
    101 Sinopharm Gezhouba Central Hospital Yichang Hubei China 443000
    102 The First Hospital of YC Yichang Hubei China 443000
    103 Yichang Central People's Hospital Yichang Hubei China 443000
    104 Yichang Hospital of Traditional Chinese Medicine Yichang Hubei China 443000
    105 Yichang Second People's Hospital Yichang Hubei China 443000
    106 Yidu People's Hospital Yichang Hubei China 443000
    107 Yiling Hospital of Yichang Yichang Hubei China 443000

    Sponsors and Collaborators

    • Wuhan Union Hospital, China
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wuhan Union Hospital, China
    ClinicalTrials.gov Identifier:
    NCT05782881
    Other Study ID Numbers:
    • CCDInT
    First Posted:
    Mar 24, 2023
    Last Update Posted:
    Mar 24, 2023
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Coronary Disease
    Diabetes Mellitus, Type 2
    Glucagon
    Glucagon-Like Peptide 1
    Enzyme Inhibitors
    Angiotensin-Converting Enzyme Inhibitors

    Study Results

    No Results Posted as of Mar 24, 2023