Screening and intervention program for high-risk cardiovascular patients in Hubei Province
High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program
This study is testing a new treatment plan to see if it can help people over 40 with heart disease and diabetes in Hubei Province have fewer heart problems compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16000 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Wuhan Union Hospital, China Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 107 sites (Enshi, Hubei and 106 other locations) |
| Trial ID | NCT05782881 on ClinicalTrials.gov |
What this trial studies
This program aims to evaluate the effectiveness of a protocol treatment group compared to conventional treatment in reducing the incidence of composite cardiovascular diseases among individuals aged 40 and older with coronary heart disease and type 2 diabetes. The study will recruit 16,000 participants from 14 prefecture-level cities in Hubei Province and will follow them for one year to assess various cardiovascular outcomes. Additionally, the program will investigate the genetic mechanisms underlying cardiovascular events and establish a prevention and control system for cardiovascular diseases in the region.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-75 with coronary heart disease and type 2 diabetes.
Not a fit: Patients with recent coronary stent treatment, severe cardiovascular complications, or other serious health conditions may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly reduce the incidence of serious cardiovascular events in high-risk patients.
How similar studies have performed: Other studies have shown success in similar interventions for cardiovascular disease management, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Enshi, Hubei and 106 other locations
- Affiliated Minzu University Hospital of Hubei Minzu University — Enshi, Hubei, China (Not_yet_recruiting)
- Badong Peolple's Hospital — Enshi, Hubei, China (Not_yet_recruiting)
- Enshi Central Hospital — Enshi, Hubei, China (Not_yet_recruiting)
- Laifeng People's Hospital — Enshi, Hubei, China (Not_yet_recruiting)
- Lichuan People's Hospital — Enshi, Hubei, China (Not_yet_recruiting)
- The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture — Enshi, Hubei, China (Not_yet_recruiting)
- The People's Hospital of Jianshi — Enshi, Hubei, China (Not_yet_recruiting)
- Xianfeng County People's Hospital — Enshi, Hubei, China (Not_yet_recruiting)
- Xuanen People's Hospital — Enshi, Hubei, China (Not_yet_recruiting)
- Ezhou Central Hospital — Ezhou, Hubei, China (Not_yet_recruiting)
- Ezhou Hospital of Chinese Medicine — Ezhou, Hubei, China (Not_yet_recruiting)
- Hongan People's Hospital — Huanggang, Hubei, China (Not_yet_recruiting)
- Huangmei Peolple's Hospital — Huanggang, Hubei, China (Not_yet_recruiting)
- Luotian People's Hospital — Huanggang, Hubei, China (Not_yet_recruiting)
- People's Hostpital of Macheng City — Huanggang, Hubei, China (Not_yet_recruiting)
- Qichun People's Hospital — Huanggang, Hubei, China (Not_yet_recruiting)
- The People's Hospital of Tuanfeng — Huanggang, Hubei, China (Not_yet_recruiting)
- Wuxue People's Hopital — Huanggang, Hubei, China (Not_yet_recruiting)
- Xishui People's Hospital — Huanggang, Hubei, China (Not_yet_recruiting)
- Yingshan People's Hospital — Huanggang, Hubei, China (Not_yet_recruiting)
- Daye People's Hospital — Huangshi, Hubei, China (Not_yet_recruiting)
- Huangshi Central Hospital — Huangshi, Hubei, China (Not_yet_recruiting)
- Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic University — Huangshi, Hubei, China (Not_yet_recruiting)
- Yangxin People's Hospital — Huangshi, Hubei, China (Not_yet_recruiting)
- Jingmen NO.1 People's Hospital — Jingmen, Hubei, China (Not_yet_recruiting)
- Jingmen NO.2 People's Hospital — Jingmen, Hubei, China (Not_yet_recruiting)
- Jingshan Union Hospital of Huazhong University of Science and Technology — Jingmen, Hubei, China (Not_yet_recruiting)
- Zhongxiang Hospital of Traditional Chinese Medicine — Jingmen, Hubei, China (Not_yet_recruiting)
- Zhongxiang People's Hospital — Jingmen, Hubei, China (Not_yet_recruiting)
- Chinese Medicine Hospital of Gongan — Jingzhou, Hubei, China (Not_yet_recruiting)
- Chinese Medicine Hospital of Honghu — Jingzhou, Hubei, China (Not_yet_recruiting)
- Jiangling People's Hospital — Jingzhou, Hubei, China (Not_yet_recruiting)
- Jianli Hospital of Chinese Medicine — Jingzhou, Hubei, China (Not_yet_recruiting)
- Jianli People's Hospital — Jingzhou, Hubei, China (Not_yet_recruiting)
- Jingzhou Central Hospital — Jingzhou, Hubei, China (Not_yet_recruiting)
- Jingzhou Hospital of Traditional Chinese Medicine — Jingzhou, Hubei, China (Not_yet_recruiting)
- Jingzhou No.1 People's Hospital — Jingzhou, Hubei, China (Not_yet_recruiting)
- People's Hospital of Gongan — Jingzhou, Hubei, China (Not_yet_recruiting)
- People's Hospital of Honghu — Jingzhou, Hubei, China (Not_yet_recruiting)
- Shishou People's Hostpital — Jingzhou, Hubei, China (Not_yet_recruiting)
- Songzi of Traditional Chinese Medicine — Jingzhou, Hubei, China (Not_yet_recruiting)
- Songzi People's Hospital — Jingzhou, Hubei, China (Not_yet_recruiting)
- The Second Hospital of Jingzhou — Jingzhou, Hubei, China (Not_yet_recruiting)
- The Second People's Hospital of Jianli — Jingzhou, Hubei, China (Not_yet_recruiting)
- Danjiangkou First Hospital — Shiyan, Hubei, China (Not_yet_recruiting)
- Fang County People's Hospital — Shiyan, Hubei, China (Not_yet_recruiting)
- Shiyan Renmin Hospital — Shiyan, Hubei, China (Not_yet_recruiting)
- Sinopharm Dongfeng General Hospital, Hubei University of Medicine — Shiyan, Hubei, China (Not_yet_recruiting)
- Taihe Hospital — Shiyan, Hubei, China (Not_yet_recruiting)
- Xunyang People's Hospital — Shiyan, Hubei, China (Not_yet_recruiting)
+57 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Shan Deng, doctor
- Email: dengshan1020@hust.edu.cn
- Phone: 18120556507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.