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

NCT ID: NCT02509013

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-12-31

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.

Conditions

Coronary Heart Disease; Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong Huo

Director, Department of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong Huo, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University First hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Jiang, MD

Role: CONTACT

jiangjie@medmail.com.cn

8610-83575180

Facility Contacts

Zhaoping Liu, MD

Role: primary

liuzhpbmu@vip.163.com

8610-83575180

Other Identifiers

WI198103

Identifier Type: -

Identifier Source: org_study_id