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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02509013
• Other study ID #: WI198103
• Status: Recruiting
• Phase: N/A
• First received: July 23, 2015
• Last updated: June 20, 2016
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: June 2016
• Source: Peking University First Hospital
• Contact: Jie Jiang, MD
• Phone: 8610-83575180
• Email: jiangjie[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Kidney Diseases
• Myocardial Ischemia
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
China	Peking University First hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of chronic kidney disease in patients with stable coronary heart disease	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.	1 year	No
Secondary	the awareness rate of chronic kidney disease in patients with stable coronary heart disease		1 year	No
Secondary	factors associated with chronic kidney disease in patients with stable coronary heart disease	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.	1 year	No
Secondary	the association between CKD and cardiovascular events during one-year's follow-up	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.	2 year	No