Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02509013
Previous Study | Return to List | Next Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02509013
Recruitment Status : Unknown
Verified June 2016 by Yong Huo, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : July 27, 2015
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital

Tracking Information
First Submitted Date July 23, 2015
First Posted Date July 27, 2015
Last Update Posted Date June 21, 2016
Study Start Date August 2015
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 23, 2015)
  • the awareness rate of chronic kidney disease in patients with stable coronary heart disease [ Time Frame: 1 year ]
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Coronary Heart Disease
  • Chronic Kidney Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 23, 2015)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02509013
Other Study ID Numbers WI198103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yong Huo, Peking University First Hospital
Study Sponsor Peking University First Hospital
Collaborators Pfizer
Investigators
Principal Investigator: Yong Huo, MD Peking University First Hospital
PRS Account Peking University First Hospital
Verification Date June 2016