Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart Disease
NCT02509013
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Age≥18 years.
- Patients with clinical evidence of stable coronary heart disease, who meet at least one of the following three criterias:
a. Stable coronary heart disease with objective evidence of atherosclerosis, either coronary angiography shows ≥50% stenosis of at least one of the coronary main stems or first-level branches, or typical exertional angina pectoris with positive stress tests(ECG stress test, echocardiograph stress test, or stress radionuclide myocardial imaging). b Diagnosed of myocardial infarction at least 3 months before recruitment. c.Coronary revascularization(PCI or CABG) at least 3 months before recruitment.
- Informed consent signed by patients or legal guardians.
- Willing to and capable of being followed up for 1 year.
- Non-atherosclerotic coronary heart disease
- Deterioration of heart failure during the past 3 months
- Exposed to contrast agent during the past one month.
- History of amputation
- Pregnancy
- Female patients in menstrual period(still eligible after menstrual period)
- Organ failure other than heart failure and kidney failure
- Comorbid other diseases, and life expectancy <1 year
- Considered not fit for the study due to other reasons, including but not restricted to
: a. Severe infection; b. Acute kidney injury.
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- Beijing, Beijing
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart Disease | |||
| Official Title | Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart Disease: a Prospective, Multi-center, Hospital-based Study | |||
| Brief Summary | This is a prospective, multi-center, hospital-based observational study. The aim of the study is to evaluate the prevalence of chronic kidney disease in patients with stable coronar heart disease. | |||
| Detailed Description | The primary aim of the study is to evaluate the prevalence of chronic kidney disease(CKD) in patients with stable coronary heart disease. The secondary aims include: 1. To evaluate the awareness of CKD in patients with stable coronary heart disease. 2. To find out risk factors that is associated with CKD in these patients. 3. To evaluate the association between CKD and cardiovascular events during one-year's follow-up. Based on sample size estimation, the plan is to recruit 10000 patients from 100 centers. Patients who participate the study will finish one-year's follow up (0 day, 6 months and 12 months after recruitment). During the baseline visit, patients' demographic characters will be collected, and laboratory tests will be performed for urinalysis, renal function, hepatic function, etc. During the 6 months' follow up, MACE(Major adverse cardiovascular events) will be recorded through phone or face to face interview between investigators and patients. MACE include all-cause mortality, cardiovascular mortality, non-fatal myocardial infarction, documented re-hospitalization for unstable angina pectoris, and coronary revascularization (including percutaneous coronary intervention and CABG). During the 12 month's follow up, MACE will be recorded, and laboratory tests will be performed again. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | 100 eligible sites over the country will participate. Each site will recruit patients who fit the inclusion standard in chronological order | |||
| Condition |
| |||
| Intervention | Not Provided | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Unknown status | |||
| Estimated Enrollment | 10000 | |||
| Original Estimated Enrollment | Same as current | |||
| Estimated Study Completion Date | December 2017 | |||
| Estimated Primary Completion Date | March 2017 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | China | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT02509013 | |||
| Other Study ID Numbers | WI198103 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement |
| |||
| Responsible Party | Yong Huo, Peking University First Hospital | |||
| Study Sponsor | Peking University First Hospital | |||
| Collaborators | Pfizer | |||
| Investigators |
| |||
| PRS Account | Peking University First Hospital | |||
| Verification Date | June 2016 | |||