Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart Disease

• Conditions: Chronic Kidney Disease; Coronary Heart Disease

• Registration Number: NCT02509013
• Lead Sponsor: Peking University First Hospital

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 Timeline

• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-27
• Study Start: 2015-08
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-20
• Last Update Posted: 2016-06-21
• Primary Completion: 2017-03
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of chronic kidney disease in patients with stable coronary heart disease	1 year	After recruitment, urinalysis, urine albumin/creatinine ratio(ACR), and serum creatitine will be tested. Chronic kidney disease is defined as ≥1 of the following abnormalities: 1)estimated GFR\<60ml/min per1.73m2. The eGFR is estimated using the CKD-EPI equation ; 2) Presence of proteinuria. Proteinuria is defined as urine ACR \>30mg/g, or urinalysis showing positive proteinuria.

Secondary Outcome Measures

Name	Time	Method
factors associated with chronic kidney disease in patients with stable coronary heart disease	1 year	The participants will be divided into two groups based on whether CKD is present. Means and proportions will be used to describe the baseline characteristics(e.g. gender, age, history of hypertension, diabetes mellitus, dyslipidemia, and laboratory results, etc.) . T tests and chi-square tests will be used to test differences between CKD group and non-CKD group, to explore factors that are associated with the presence of CKD. Independent associations between presence of CKD and individual characteristics will be assessed using multivariable logistic models.
the awareness rate of chronic kidney disease in patients with stable coronary heart disease	1 year
the association between CKD and cardiovascular events during one-year's follow-up	2 year	The rate of occurrence of MACE after one-year's follow-up will be described in the CKD group and non-CKD group. Univariate and multivariate cox proportional hazard model will be used to analyze whether the presence of CKD is an independent risk factor for the occurrence of MACE one year after.

Trial Locations

Locations (1)

Peking University First hospital; 🇨🇳 Beijing, Beijing, China