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

NCT05782881 — Not applicable, Unknown, 16000 participants, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

RegistryNCT05782881
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment16000 (Estimated)
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology (Other); collaborators: Peking University First Hospital
ConditionsCardiovascular Diseases, Diabetes Mellitus, Type 2, Coronary Disease
Interventionsphone calls and encouraging patients' lifestyle change and medication adherence, Statin (Behavioral, drug)
Datesstart 2023-01-15, primary completion 2023-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2023-03-24, last updated 2023-12-15
Locations107 sites in China

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Protocol treatment groupExperimentalBehavioral: phone calls and encouraging patients' lifestyle change and medication adherence; Drug: StatinStrictly intervene blood glucose, blood pressure and blood lipids
Conventional treatment groupPlacebo comparatorDrug: StatinTreatment and management according to the guidelines
  • phone calls and encouraging patients' lifestyle change and medication adherence (Behavioral): Use some methods to strictly intervene blood glucose , blood pressure and blood lipids for protocol treatment group people.
  • Statin (Drug), also known as Angiotensin-converting enzyme inhibitor, Angiotensin receptor neprilysin inhibitor, Glucagon-like peptide-1, Sodium-dependent glucose transporters 2: Treatment and management according to the guidelines

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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)

+Eligibility

Sex: All, ages: 40 Years to 75 Years

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

+Locations (107)

FacilityCityCountryStatus
Affiliated Minzu University Hospital of Hubei Minzu UniversityEnshi, HubeiChinaNot yet recruiting
Badong Peolple's HospitalEnshi, HubeiChinaNot yet recruiting
Enshi Central HospitalEnshi, HubeiChinaNot yet recruiting
Laifeng People's HospitalEnshi, HubeiChinaNot yet recruiting
Lichuan People's HospitalEnshi, HubeiChinaNot yet recruiting
The Central Hospital of Enshi Tujia and Miao Autonomous PrefectureEnshi, HubeiChinaNot yet recruiting
The People's Hospital of JianshiEnshi, HubeiChinaNot yet recruiting
Xianfeng County People's HospitalEnshi, HubeiChinaNot yet recruiting
Xuanen People's HospitalEnshi, HubeiChinaNot yet recruiting
Ezhou Central HospitalEzhou, HubeiChinaNot yet recruiting
Ezhou Hospital of Chinese MedicineEzhou, HubeiChinaNot yet recruiting
Hongan People's HospitalHuanggang, HubeiChinaNot yet recruiting
Huangmei Peolple's HospitalHuanggang, HubeiChinaNot yet recruiting
Luotian People's HospitalHuanggang, HubeiChinaNot yet recruiting
People's Hostpital of Macheng CityHuanggang, HubeiChinaNot yet recruiting
Qichun People's HospitalHuanggang, HubeiChinaNot yet recruiting
The People's Hospital of TuanfengHuanggang, HubeiChinaNot yet recruiting
Wuxue People's HopitalHuanggang, HubeiChinaNot yet recruiting
Xishui People's HospitalHuanggang, HubeiChinaNot yet recruiting
Yingshan People's HospitalHuanggang, HubeiChinaNot yet recruiting
Daye People's HospitalHuangshi, HubeiChinaNot yet recruiting
Huangshi Central HospitalHuangshi, HubeiChinaNot yet recruiting
Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic UniversityHuangshi, HubeiChinaNot yet recruiting
Yangxin People's HospitalHuangshi, HubeiChinaNot yet recruiting
Jingmen NO.1 People's HospitalJingmen, HubeiChinaNot yet recruiting
Jingmen NO.2 People's HospitalJingmen, HubeiChinaNot yet recruiting
Jingshan Union Hospital of Huazhong University of Science and TechnologyJingmen, HubeiChinaNot yet recruiting
Zhongxiang Hospital of Traditional Chinese MedicineJingmen, HubeiChinaNot yet recruiting
Zhongxiang People's HospitalJingmen, HubeiChinaNot yet recruiting
Chinese Medicine Hospital of GonganJingzhou, HubeiChinaNot yet recruiting
Chinese Medicine Hospital of HonghuJingzhou, HubeiChinaNot yet recruiting
Jiangling People's HospitalJingzhou, HubeiChinaNot yet recruiting
Jianli Hospital of Chinese MedicineJingzhou, HubeiChinaNot yet recruiting
Jianli People's HospitalJingzhou, HubeiChinaNot yet recruiting
Jingzhou Central HospitalJingzhou, HubeiChinaNot yet recruiting
Jingzhou Hospital of Traditional Chinese MedicineJingzhou, HubeiChinaNot yet recruiting
Jingzhou No.1 People's HospitalJingzhou, HubeiChinaNot yet recruiting
People's Hospital of GonganJingzhou, HubeiChinaNot yet recruiting
People's Hospital of HonghuJingzhou, HubeiChinaNot yet recruiting
Shishou People's HostpitalJingzhou, HubeiChinaNot yet recruiting
Songzi of Traditional Chinese MedicineJingzhou, HubeiChinaNot yet recruiting
Songzi People's HospitalJingzhou, HubeiChinaNot yet recruiting
The Second Hospital of JingzhouJingzhou, HubeiChinaNot yet recruiting
The Second People's Hospital of JianliJingzhou, HubeiChinaNot yet recruiting
Danjiangkou First HospitalShiyan, HubeiChinaNot yet recruiting
Fang County People's HospitalShiyan, HubeiChinaNot yet recruiting
Shiyan Renmin HospitalShiyan, HubeiChinaNot yet recruiting
Sinopharm Dongfeng General Hospital, Hubei University of MedicineShiyan, HubeiChinaNot yet recruiting
Taihe HospitalShiyan, HubeiChinaNot yet recruiting
Xunyang People's HospitalShiyan, HubeiChinaNot yet recruiting
Yunxi People's HospitalShiyan, HubeiChinaNot yet recruiting
Zhushan People's HospitalShiyan, HubeiChinaNot yet recruiting
Zhuxi Hospital of Traditional Chinese MedicineShiyan, HubeiChinaNot yet recruiting
NO.1 Peoples Hospital of GuangshuiSuizhou, HubeiChinaNot yet recruiting
People's Hospital of SuixianSuizhou, HubeiChinaNot yet recruiting
Suizhou Central HospitalSuizhou, HubeiChinaNot yet recruiting
Suizhou Hospital of Traditional Chinese MedicineSuizhou, HubeiChinaNot yet recruiting
Suizhou Zengdu HospitalSuizhou, HubeiChinaNot yet recruiting
The First People's Hospital of Tianmen in Hubei ProvinceTianmen, HubeiChinaNot yet recruiting
CR & WISCO General HospitalWuhan, HubeiChinaNot yet recruiting
Fifth Hospital in WuhanWuhan, HubeiChinaNot yet recruiting
Hospital of Universal LoveWuhan, HubeiChinaNot yet recruiting
People's Hospital of Dongxihu DistrictWuhan, HubeiChinaNot yet recruiting
The Central Hospital of WuhanWuhan, HubeiChinaNot yet recruiting
Union Hospital, Tongji Medical College of Huazhong University of science and technologyWuhan, HubeiChinaRecruiting
Wuhan NO.1 HospitalWuhan, HubeiChinaNot yet recruiting
Wuhan Third Hospital-Tongren Hospital of Wuhan UniversityWuhan, HubeiChinaNot yet recruiting
Huanggang Central HospitalWuhan, HubeiChinaNot yet recruiting
Baokang People's HospitalXiangyang, HubeiChinaNot yet recruiting
Gucheng People's HospitalXiangyang, HubeiChinaNot yet recruiting
Laohekou NO.1 HospitalXiangyang, HubeiChinaNot yet recruiting
Nanzhang People's HospitalXiangyang, HubeiChinaNot yet recruiting
Xiangyang Central HospitalXiangyang, HubeiChinaNot yet recruiting
Xiangyang Hospital of Traditional Chinese MedicineXiangyang, HubeiChinaNot yet recruiting
Xiangyang NO.1 People's HospitalXiangyang, HubeiChinaNot yet recruiting
Xiangzhou People's HospitalXiangyang, HubeiChinaNot yet recruiting
Yicheng People's HosptitalXiangyang, HubeiChinaNot yet recruiting
Zaoyang NO.1 People's HospitalXiangyang, HubeiChinaNot yet recruiting
Chibi General HospitalXianning, HubeiChinaNot yet recruiting
Chongyang People's HospitalXianning, HubeiChinaNot yet recruiting
Jiayu People's HospitalXianning, HubeiChinaNot yet recruiting
The First People's Hospital of XianningXianning, HubeiChinaNot yet recruiting
TongchengPeople's HospitalXianning, HubeiChinaNot yet recruiting
Tongshan People's HospitalXianning, HubeiChinaNot yet recruiting
Xianning Central HospitalXianning, HubeiChinaNot yet recruiting
AMHT Hubei Aerospace HospitalXiaogan, HubeiChinaNot yet recruiting
Anlu Puai HospitalXiaogan, HubeiChinaNot yet recruiting
Dawu County Hosptal of Traditional Chinese MedicineXiaogan, HubeiChinaNot yet recruiting
Dawu People's HospitalXiaogan, HubeiChinaNot yet recruiting
Hanchuan People's HospitalXiaogan, HubeiChinaNot yet recruiting
The Central Hospital of XiaoganXiaogan, HubeiChinaNot yet recruiting
Xiaochang First People's HospitalXiaogan, HubeiChinaNot yet recruiting
Xiaogan First People's HospitalXiaogan, HubeiChinaNot yet recruiting
Xiaogan Hoospital of Chinese MedicineXiaogan, HubeiChinaNot yet recruiting
Yingcheng People's HospitalXiaogan, HubeiChinaNot yet recruiting
Yunmeng People's HospitalXiaogan, HubeiChinaNot yet recruiting
Affiliated Renhe Hospital of China Three GORGES UniversityYichang, HubeiChinaNot yet recruiting
People's Hospital of DangyangYichang, HubeiChinaNot yet recruiting
People's Hospital of ZhijiangYichang, HubeiChinaNot yet recruiting
People's Hospital of ZiguiYichang, HubeiChinaNot yet recruiting

7 more sites not listed.

+Investigators

  • Kai Huang, doctor, Study chair, Union Hospital, Tongji Medical College of Huazhong University of science and technology
  • Yong Huo, doctor, Study chair, Peking University First Hospital

My Notes