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Trial record 2 of 2886 for:    Chronic Kidney Disease

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02509013
Recruitment Status : Recruiting
First Posted : July 27, 2015
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Coronary Heart Disease Chronic Kidney 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 Design

Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : August 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017

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U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. prevalence of chronic kidney disease in patients with stable coronary heart disease [ Time Frame: 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 :
  1. the awareness rate of chronic kidney disease in patients with stable coronary heart disease [ Time Frame: 1 year ]
  2. factors associated with chronic kidney disease in patients with stable coronary heart disease [ Time Frame: 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.

  3. the association between CKD and cardiovascular events during one-year's follow-up [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509013


Contacts
Contact: Jie Jiang, MD 8610-83575180 jiangjie@medmail.com.cn

Locations
China, Beijing
Peking University First hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Zhaoping Liu, MD    8610-83575180    liuzhpbmu@vip.163.com   
Sub-Investigator: Zhaoping Liu, MD         
Sponsors and Collaborators
Peking University First Hospital
Pfizer
Investigators
Principal Investigator: Yong Huo, MD Peking University First Hospital
More Information

Responsible Party: Yong Huo, Director, Department of Cardiology, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02509013     History of Changes
Other Study ID Numbers: WI198103
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yong Huo, Peking University First Hospital:
chronic kidney disease
stable coronary heart disease
prevalence

Additional relevant MeSH terms:
Kidney Diseases
Heart Diseases
Renal Insufficiency, Chronic
Coronary Disease
Coronary Artery Disease
Urologic Diseases
Cardiovascular Diseases
Renal Insufficiency
Vascular Diseases
Arterial Occlusive Diseases
Myocardial Ischemia
Arteriosclerosis