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

NCT02509013

Last updated date
Study Location
Peking University First hospital
Beijing, Beijing, 100034, China
Contact
8610-83575180

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Coronary Heart Disease, Chronic Kidney Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Coronary Heart Disease, Chronic Kidney DiseasePrevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart Disease
NCT02509013
  1. Beijing, Beijing
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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, MDPeking University First Hospital
PRS Account Peking University First Hospital
Verification Date June 2016