Clinical trial NCT02509013: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Chronic Kidney Disease
Keywords: chronic kidney disease
stable coronary heart disease
prevalence
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2015-07-27
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: prevalence of chronic kidney disease in patients with stable coronary heart disease
timeFrame: 1 year
Secondary outcomes:
measure: the awareness rate of chronic kidney disease in patients with stable coronary heart disease
timeFrame: 1 year
measure: factors associated with chronic kidney disease in patients with stable coronary heart disease
timeFrame: 1 year
measure: the association between CKD and cardiovascular events during one-year's follow-up
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Yong Huo, MD
role: PRINCIPAL_INVESTIGATOR
References: