Cardiovascular DiseasesNCT05782881
High Risk Population of Cardiovascular Disease in Hubei Province Screening and Intervention Program
A study testing phone calls and encouraging patients' lifestyle change and medication adherence and Statin in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 107 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Coronary Disease
- What is being tested?
- phone calls and encouraging patients' lifestyle change and medication adherence and Statin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16,000 participants
- Where
- 107 sitesChina
- Study dates
- 15 Jan 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-75 years old, male or female
- Patients with coronary heart disease complicated with type 2 diabetes (confirmed by angiography)
- Low density lipoprotein cholesterol >1.8mmol/l
- Willing to participate and sign informed consent
Who cannot join
- Received coronary stent treatment in recent one year
- Pregnant or lactating women
- Decompensated stage of chronic systolic heart failure (NYHA cardiac function rating ≥ 3), cardiac function; Patients with severe cardiovascular complications such as septic shock
- Stroke patients in recent 1 year
- Patients with severe gastrointestinal diseases, liver failure or kidney failure
- Cancer patients or patients who have received radiotherapy or chemotherapy within five years
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- Suffering from infectious diseases such as AIDS and tuberculosis
- Hospitalized or suffering from other serious diseases requiring immediate hospitalization
- Bad addicts: drug users or alcoholics (men >80 g / day, women >40 g / day)
- Disturbance of consciousness, inability to communicate normally or any mental illness; Those who are inconvenient to take care of themselves or move
- Life expectancy <12 months
- Individuals with abnormal laboratory tests and clinical manifestations who are judged by the researcher to be unsuitable for participation
- Unwilling to participate in the trial, unwilling to change the current drug treatment plan
Trial locations and contacts
107 sites in 1 country.
107 sites in 1 country
China107 sites, 107 recruiting
- Not yet recruiting
Affiliated Minzu University Hospital of Hubei Minzu University
Enshi, Hubei, 445000
Changjiang Zhang, 15586681001, 39006100@qq.com
- Not yet recruiting
Badong Peolple's Hospital
Enshi, Hubei, 445000
Kaiyong Chen, 13597775408, 3301188278@qq.com
- Not yet recruiting
Enshi Central Hospital
Enshi, Hubei, 445000
Miao Yu, 18695059008, 1328128062@qq.com
- Not yet recruiting
Laifeng People's Hospital
Enshi, Hubei, 445000
Chengzhong Zhang, 18986844683, 875566847@qq.com
- Not yet recruiting
Lichuan People's Hospital
Enshi, Hubei, 445000
Liang Xiong, 13907263406, 409757683@qq.com
- Not yet recruiting
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi, Hubei, 445000
Yuhua Lei, 13986843858, 2339572778@qq.com
- Not yet recruiting
The People's Hospital of Jianshi
Enshi, Hubei, 445000
Mingfu Ma, 13997795565, 307899075@qq.com
- Not yet recruiting
Xianfeng County People's Hospital
Enshi, Hubei, 445000
Bo Yang, 18007266823, 290469524@qq.com
- Not yet recruiting
Xuanen People's Hospital
Enshi, Hubei, 445000
Yizheng He, 18671833311, 1957999408@qq.com
- Not yet recruiting
Ezhou Central Hospital
Ezhou, Hubei, 436000
Guang Xu, 13607236327, 1341189733@qq.com
- Not yet recruiting
Ezhou Hospital of Chinese Medicine
Ezhou, Hubei, 436000
Yuan Ke, 18071178686, 1575523398@qq.com
- Not yet recruiting
Hongan People's Hospital
Huanggang, Hubei, 438000
Jianhua Li, 13886407005, lijianhua2004@126.com
- Not yet recruiting
Huangmei Peolple's Hospital
Huanggang, Hubei, 438000
Ziwei Mei, 13098360265, 2207990688@qq.com
- Not yet recruiting
Luotian People's Hospital
Huanggang, Hubei, 438000
Xiaoqin Zhang, 13476762168, zhxiaoq@163.com
- Not yet recruiting
People's Hostpital of Macheng City
Huanggang, Hubei, 438000
Liangchen Zheng, 15997391119, 717029682@qq.com
- Not yet recruiting
Qichun People's Hospital
Huanggang, Hubei, 438000
Ying Zhang, 13636032023, 3636032023@163.com
- Not yet recruiting
The People's Hospital of Tuanfeng
Huanggang, Hubei, 438000
Zhixiang Lin, 15549659486, 2491302322@qq.com
- Not yet recruiting
Wuxue People's Hopital
Huanggang, Hubei, 438000
Min Wang, 15171676751, 291311088@qq.com
- Not yet recruiting
Xishui People's Hospital
Huanggang, Hubei, 438000
Wenming Zhan, 15897927322, 283075493@qq.com
- Not yet recruiting
Yingshan People's Hospital
Huanggang, Hubei, 438000
Rong Zeng, 18071815368, 1515899635@qq.com
- Not yet recruiting
Daye People's Hospital
Huangshi, Hubei, 435000
Zhichao Yin, 13972783068, yinzhichao2000@Sina.com
- Not yet recruiting
Huangshi Central Hospital
Huangshi, Hubei, 435000
Daoqun Jin, 13597680361, Jindaoqun226@163.com
- Not yet recruiting
Huangshi Love&Health Hospital Affiliated of Hubei Polytechnic University
Huangshi, Hubei, 435000
Jing Zhang, 18971785886, 7752360@qq.com
- Not yet recruiting
Yangxin People's Hospital
Huangshi, Hubei, 435000
Shijian Chen, 13972417968, 17253669@qq.com
- Not yet recruiting
Jingmen NO.1 People's Hospital
Jingmen, Hubei, 448000
Huijuan Lai, 13997946256, 995004757@qq.com
- Not yet recruiting
Jingmen NO.2 People's Hospital
Jingmen, Hubei, 448000
Shuju Shi, 13477541757, 2280267706@qq.com
- Not yet recruiting
Jingshan Union Hospital of Huazhong University of Science and Technology
Jingmen, Hubei, 448000
Jun Shao, 13409604460, 478651621@qq.com
- Not yet recruiting
Zhongxiang Hospital of Traditional Chinese Medicine
Jingmen, Hubei, 448000
Mingqin Li, 13597947023, 547810505@qq.com
- Not yet recruiting
Zhongxiang People's Hospital
Jingmen, Hubei, 448000
Jiaqi Tian, 13277645012, 82684496@qq.com
- Not yet recruiting
Chinese Medicine Hospital of Gongan
Jingzhou, Hubei, 434000
Yu Wang, 13545689661, wy1981315@163.com
- Not yet recruiting
Chinese Medicine Hospital of Honghu
Jingzhou, Hubei, 434000
Qin Cao, 13872213030, caoqin7036@163.com
- Not yet recruiting
Jiangling People's Hospital
Jingzhou, Hubei, 434000
Hong Bao, 13797283699, 836014@qq.com
- Not yet recruiting
Jianli Hospital of Chinese Medicine
Jingzhou, Hubei, 434000
Haie Song, 15826588607, 188087687@qq.com
- Not yet recruiting
Jianli People's Hospital
Jingzhou, Hubei, 434000
Jibo Wang, 15872138637, 56228052@qq.com
- Not yet recruiting
Jingzhou Central Hospital
Jingzhou, Hubei, 434000
Keping Yang, 18107168679, 30461400@qq.com
- Not yet recruiting
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, 434000
Songbai Qin, 18972168822, qsb511@163.com
- Not yet recruiting
Jingzhou No.1 People's Hospital
Jingzhou, Hubei, 434000
Shaning Yang, 18972161898, 1966157381@qq.com
- Not yet recruiting
People's Hospital of Gongan
Jingzhou, Hubei, 434000
Xiangyang Xia, 19186001128, 67729152@qq.com
- Not yet recruiting
People's Hospital of Honghu
Jingzhou, Hubei, 434000
Hong Liu, 13797431083, 453192480@qq.com
- Not yet recruiting
Shishou People's Hostpital
Jingzhou, Hubei, 434000
Jian Zhang, 19986783555, 2971473540@qq.com
- Not yet recruiting
Songzi of Traditional Chinese Medicine
Jingzhou, Hubei, 434000
Jie Zhang, 13217264663, 943524261@qq.com
- Not yet recruiting
Songzi People's Hospital
Jingzhou, Hubei, 434000
Bin Li, 19972675950, 983022169@qq.com
- Not yet recruiting
The Second Hospital of Jingzhou
Jingzhou, Hubei, 434000
Bing Yuan, 15926588092, 5926588092@163.com
- Not yet recruiting
The Second People's Hospital of Jianli
Jingzhou, Hubei, 434000
Jun Du, 13986666305, abs81@126.com
- Not yet recruiting
Danjiangkou First Hospital
Shiyan, Hubei, 442000
Yanpeng Duan, 15335962032, 29410085@qq.com
- Not yet recruiting
Fang County People's Hospital
Shiyan, Hubei, 442000
Dongfang Chen, 15272298338, 5272298338@139.com
- Not yet recruiting
Shiyan Renmin Hospital
Shiyan, Hubei, 442000
Youen Zhang, 13636151885, 77309406@qq.com
- Not yet recruiting
Sinopharm Dongfeng General Hospital, Hubei University of Medicine
Shiyan, Hubei, 442000
Xinwen Min, 13986892161, minxinwen@163.com
- Not yet recruiting
Taihe Hospital
Shiyan, Hubei, 442000
Zheng Cao, 13972458886, caozheng908@163.com
- Not yet recruiting
Xunyang People's Hospital
Shiyan, Hubei, 442000
Lin Wang, 15997808104, 824639808@qq.com
- Not yet recruiting
Yunxi People's Hospital
Shiyan, Hubei, 442000
Mingxia Ren, 13508688301, 10989777182@qq.com
- Not yet recruiting
Zhushan People's Hospital
Shiyan, Hubei, 442000
Yiming Shi, 15071581178, 1074539858@qq.com
- Not yet recruiting
Zhuxi Hospital of Traditional Chinese Medicine
Shiyan, Hubei, 442000
Sanjun Zhou, 15971905288, 47929925@qq.com
- Not yet recruiting
NO.1 Peoples Hospital of Guangshui
Suizhou, Hubei, 441300
Quansheng Feng, 13886851677, 2652061940@qq.com
- Not yet recruiting
People's Hospital of Suixian
Suizhou, Hubei, 441300
Jiaqing Hu, 18316980717, 513373710@qq.com
- Not yet recruiting
Suizhou Central Hospital
Suizhou, Hubei, 441300
Neng Wang, 15897650556, 907544242@qq.com
- Not yet recruiting
Suizhou Hospital of Traditional Chinese Medicine
Suizhou, Hubei, 441300
Hong Ding, 15191564705, dinghongyisheng@163.com
- Not yet recruiting
Suizhou Zengdu Hospital
Suizhou, Hubei, 441300
Xiaosong Qian, 15997909680, 123201835@qq.com
- Not yet recruiting
The First People's Hospital of Tianmen in Hubei Province
Tianmen, Hubei, 431700
Hui Wei, 18972189083, 18972189083@126.com
- Not yet recruiting
CR & WISCO General Hospital
Wuhan, Hubei, 430000
Juan Zhao, 13871560814, 283736034@qq.com
- Not yet recruiting
Fifth Hospital in Wuhan
Wuhan, Hubei, 430000
Beijia Chen, 15907144030, 461520651@qq.com
- Not yet recruiting
Hospital of Universal Love
Wuhan, Hubei, 430000
Xinying Wu, 15972977195, wuxinying_620@163.com
- Not yet recruiting
People's Hospital of Dongxihu District
Wuhan, Hubei, 430000
Qin Jin, 18986060206, 692816509@qq.com
- Not yet recruiting
The Central Hospital of Wuhan
Wuhan, Hubei, 430000
Yayun Wang, 15971496405, 281076598@qq.com
- Recruiting
Union Hospital, Tongji Medical College of Huazhong University of science and technology
Wuhan, Hubei, 430000
Shan Deng, post-doctor, 18120556507, dengshan1020@hust.edu.cn
- Not yet recruiting
Wuhan NO.1 Hospital
Wuhan, Hubei, 430000
Ying Feng, 13986111159, xoxoclair@126.com
- Not yet recruiting
Wuhan Third Hospital-Tongren Hospital of Wuhan University
Wuhan, Hubei, 430000
Qing Li, 13638690613, 944719579@qq.com
- Not yet recruiting
Huanggang Central Hospital
Wuhan, Hubei, 438000
Hongli Zhao, 13277203657, 1349565097@qq.com
- Not yet recruiting
Baokang People's Hospital
Xiangyang, Hubei, 441000
Shiquan Zhu, 15172652103, 15172652103@163.com
- Not yet recruiting
Gucheng People's Hospital
Xiangyang, Hubei, 441000
Yanpin Zhang, 15172572229, ttxsping@qq.com
- Not yet recruiting
Laohekou NO.1 Hospital
Xiangyang, Hubei, 441000
Li Chang, 18372273066, 303537582@qq.com
- Not yet recruiting
Nanzhang People's Hospital
Xiangyang, Hubei, 441000
Hongyan Li, 13774154357, 3120695672@qq.com
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
Yanzhao Wei, 17343315303, yankeeway3@gmail.com
- Not yet recruiting
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, 441000
Jia Liu, 18845058025, 1303779021@qq.com
- Not yet recruiting
Xiangyang NO.1 People's Hospital
Xiangyang, Hubei, 441000
Lu Li, 13277117628, 351908331@qq.com
- Not yet recruiting
Xiangzhou People's Hospital
Xiangyang, Hubei, 441000
Feng Yang, 13085281533, chuanfengyang@163.com
- Not yet recruiting
Yicheng People's Hosptital
Xiangyang, Hubei, 441000
Yuzhi Gong, 13886242550, gyz_4255153@163.com
- Not yet recruiting
Zaoyang NO.1 People's Hospital
Xiangyang, Hubei, 441000
Zhen Yang, 15172615100, 1174244875@qq.com
- Not yet recruiting
Chibi General Hospital
Xianning, Hubei, 437000
Xiuzhen Shen, 13797796821, 980673518@qq.com
- Not yet recruiting
Chongyang People's Hospital
Xianning, Hubei, 437000
Zongqiang Wang, 13986629258, 1556969242@qq.com
- Not yet recruiting
Jiayu People's Hospital
Xianning, Hubei, 437000
Zaishu Chen, 13972837573, jyczs02@163.com
- Not yet recruiting
The First People's Hospital of Xianning
Xianning, Hubei, 437000
Qibing Zheng, 18986631048, 1554284581@qq.com
- Not yet recruiting
TongchengPeople's Hospital
Xianning, Hubei, 437000
Longcai Hu, 13997530854, 492429963@qq.com
- Not yet recruiting
Tongshan People's Hospital
Xianning, Hubei, 437000
Fuzhong Wang, 13807242362, 419415005@qq.com
- Not yet recruiting
Xianning Central Hospital
Xianning, Hubei, 437000
Shouyi Gan, 18671529858, 24649899@qq.com
- Not yet recruiting
AMHT Hubei Aerospace Hospital
Xiaogan, Hubei, 432000
Dachun He, 13886368252, hdc.998@163.com
- Not yet recruiting
Anlu Puai Hospital
Xiaogan, Hubei, 432000
Yousheng Yang, 15207296549, 42759600@qq.com
- Not yet recruiting
Dawu County Hosptal of Traditional Chinese Medicine
Xiaogan, Hubei, 432000
Xiaohong Yao, 13886381640, 761158195@qq.com
- Not yet recruiting
Dawu People's Hospital
Xiaogan, Hubei, 432000
Yinbo Li, 13797188333, 1004017703@qq.com
- Not yet recruiting
Hanchuan People's Hospital
Xiaogan, Hubei, 432000
Shaobo Wang, 13797180359, 1589885345@qq.com
- Not yet recruiting
The Central Hospital of Xiaogan
Xiaogan, Hubei, 432000
Ronghua He, 13871883008, 781008@163.com
- Not yet recruiting
Xiaochang First People's Hospital
Xiaogan, Hubei, 432000
Zhihua Zhang, 13972679321, 260592745@qq.com
- Not yet recruiting
Xiaogan First People's Hospital
Xiaogan, Hubei, 432000
Yazhou Li, 15971205579, 284380951@qq.com
- Not yet recruiting
Xiaogan Hoospital of Chinese Medicine
Xiaogan, Hubei, 432000
Zenan Zou, 18327681930, 1127448890@qq.com
- Not yet recruiting
Yingcheng People's Hospital
Xiaogan, Hubei, 432000
Libing Zhang, 13617235542, 3617235542@163.com
- Not yet recruiting
Yunmeng People's Hospital
Xiaogan, Hubei, 432000
Hanzhu An, 18607295123, 457077743@qq.com
- Not yet recruiting
Affiliated Renhe Hospital of China Three GORGES University
Yichang, Hubei, 443000
Weihua Yang, 15997680976, 664540165@qq.com
- Not yet recruiting
People's Hospital of Dangyang
Yichang, Hubei, 443000
Fan Li, 15997569640, 150457421@qq.com
- Not yet recruiting
People's Hospital of Zhijiang
Yichang, Hubei, 443000
Bing Zhang, 15972701678, 1400526650@qq.com
- Not yet recruiting
People's Hospital of Zigui
Yichang, Hubei, 443000
Dejian Fu, 13032742977, 404594917@qq.com
- Not yet recruiting
Sinopharm Gezhouba Central Hospital
Yichang, Hubei, 443000
Zhixian Lu, 13986811865, luzhixian69@126.com
- Not yet recruiting
The First Hospital of YC
Yichang, Hubei, 443000
Yunbo Lv, 13339787878, 362435582@qq.com
- Not yet recruiting
Yichang Central People's Hospital
Yichang, Hubei, 443000
Hui Wu, 15171833889, 545500870@qq.com
- Not yet recruiting
Yichang Hospital of Traditional Chinese Medicine
Yichang, Hubei, 443000
Qiang Xu, 13886741181, 9463488@qq.com
- Not yet recruiting
Yichang Second People's Hospital
Yichang, Hubei, 443000
Shijin Chen, 18908601871, 253089640@qq.com
- Not yet recruiting
Yidu People's Hospital
Yichang, Hubei, 443000
Zhibin Peng, 18972036700, 395661632@qq.com
- Not yet recruiting
Yiling Hospital of Yichang
Yichang, Hubei, 443000
Weiping Li, 13996967818, 2684784069@qq.com
About this study
Official title: 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.
Read the 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.
- Being tested
- phone calls and encouraging patients' lifestyle change and medication adherence, Statin
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone calls and encouraging patients' lifestyle change and medication adherenceBehavioural
Use some methods to strictly intervene blood glucose , blood pressure and blood lipids for protocol treatment group people.
StatinDrug
Also called Angiotensin-converting enzyme inhibitor, Angiotensin receptor neprilysin inhibitor, Glucagon-like peptide-1, Sodium-dependent glucose transporters 2
Treatment and management according to the guidelines
| Study group | Role | What they receive |
|---|---|---|
| Protocol treatment group | Experimental | Strictly intervene blood glucose, blood pressure and blood lipids Receives: Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence; Drug: Statin |
| Conventional treatment group | Placebo comparator | Treatment and management according to the guidelines Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite cardiovascular disease (cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome)
Record the composite cardiovascular disease(cardiovascular death, non fatal myocardial infarction, non fatal stroke, hospitalization for heart failure, and readmission for acute coronary syndrome)
Measured: 1 year after baseline
Secondary outcomes (12)
All-cause death
Number of all-cause death
Measured: 1 year after baseline
All-cause mortality
Record all-cause mortality
Measured: 1 year after baseline
Cardiovascular death
Record cardiovascular death
Measured: 1 year after baseline
non-fatal myocardial infarction
Record non-fatal myocardial infarction
Measured: 1 year after baseline
non-fatal stroke
Record non-fatal stroke
Measured: 1 year after baseline
readmission for heart failure
Record readmission for heart failure
Measured: 1 year after baseline
readmission for acute coronary syndrome
Number of patients with readmission for acute coronary syndrome
Measured: 1 year after baseline
Diabetic nephropathy
Number of patients with Diabetic nephropathy
Measured: 1 year after baseline
Proportion of hypertension control (BP<140/90 mm Hg)
Record proportion of hypertension control (BP<140/90 mm Hg)
Measured: 1 year after baseline
Proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L)
Record proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L)
Measured: 1 year after baseline
Proportion of glycosylated hemoglobin(GHb<7.0%)
Record proportion of glycosylated hemoglobin(GHb<7.0%)
Measured: 1 year after baseline
Blood pressure( both diastolic and systolic will be measured)
Record blood pressure( both diastolic and systolic will be measured)
Measured: baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start15 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
- Investigators
- Kai Huang, doctor, Study chair, Union Hospital, Tongji Medical College of Huazhong University of science and technologyYong Huo, doctor, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782881
- Sponsor's protocol ID
- CCDInT
- Status last verified
- Dec 2023
- First submitted
- 18 Feb 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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 .
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Risk Population of Cardiovascular Disease in Hubei Province (Coronary Heart Disease With Diabetes) Screening and Intervention Program
- ClinicalTrials.gov ID
- NCT05782881
- Acronym / sponsor ID
- CCDInT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Peking University First Hospital
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocol treatment group | Experimental | Behavioral: phone calls and encouraging patients' lifestyle change and medication adherence, Drug: StatinStrictly intervene blood glucose, blood pressure and blood lipids |
| Conventional treatment group | Placebo comparator | Drug: StatinTreatment and management according to the guidelines |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40-75 years old, male or female
- Patients with coronary heart disease complicated with type 2 diabetes (confirmed by angiography)
- Low density lipoprotein cholesterol >1.8mmol/l
- Willing to participate and sign informed consent
Key exclusion criteria (13 listed)
- Received coronary stent treatment in recent one year
- Pregnant or lactating women
- Decompensated stage of chronic systolic heart failure (NYHA cardiac function rating ≥ 3), cardiac function; Patients with severe cardiovascular complications such as septic shock
- Stroke patients in recent 1 year
- Patients with severe gastrointestinal diseases, liver failure or kidney failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phone calls and encouraging patients' lifestyle change and medication adherenceUse some methods to strictly intervene blood glucose , blood pressure and blood lipids for protocol treatment group people. | Behavioural | Protocol treatment group |
| StatinAlso: Angiotensin-converting enzyme inhibitor, Angiotensin receptor neprilysin inhibitor, Glucagon-like peptide-1, Sodium-dependent glucose transporters 2Treatment and management according to the guidelines | Drug | Conventional treatment group, Protocol treatment group |
Primary outcome
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)
12 secondary outcomes
All-cause death
Time frame: 1 year after baseline
All-cause mortality
Time frame: 1 year after baseline
Cardiovascular death
Time frame: 1 year after baseline
non-fatal myocardial infarction
Time frame: 1 year after baseline
non-fatal stroke
Time frame: 1 year after baseline
readmission for heart failure
Time frame: 1 year after baseline
readmission for acute coronary syndrome
Time frame: 1 year after baseline
Diabetic nephropathy
Time frame: 1 year after baseline
Proportion of hypertension control (BP<140/90 mm Hg)
Time frame: 1 year after baseline
Proportion of low density lipoprotein-cholesterol(LDL-C<1.4mmol/L)
Time frame: 1 year after baseline
Proportion of glycosylated hemoglobin(GHb<7.0%)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No. 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 .
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
107 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phone calls and encouraging patients' lifestyle change and medication adherence and Statin in people with Cardiovascular Diseases and Diabetes Mellitus, Type 2, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 107 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 107 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shan Deng, doctor (18120556507, dengshan1020@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.