Coronary Heart DiseaseNCT02509013
Prevalence of Chronic Kidney Disease and Its Association With Clinical Outcome in Patients With Coronary Heart Disease
An observational study of Coronary Heart Disease and Chronic Kidney Disease, run by Peking University First Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Chronic Kidney Disease
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 eligible sites over the country will participate. Each site will recruit patients who fit the inclusion standard in chronological order
Who may be able to join
- Age≥18 years.
- Patients with clinical evidence of stable coronary heart disease, who meet at least one of the following three criterias:
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First hospital
Beijing, Beijing Municipality, 100034
Zhaoping Liu, MD, 8610-83575180, liuzhpbmu@vip.163.com
Zhaoping Liu, MD
About this study
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
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.
Read the 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
- Keywords
- chronic kidney disease, stable coronary heart disease, prevalence
- Medical subject headings
- Coronary Disease, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
the awareness rate of chronic kidney disease in patients with stable coronary heart disease
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
- Investigators
- Yong Huo, MD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509013
- Sponsor's protocol ID
- WI198103
- Status last verified
- Jun 2016
- First submitted
- 23 Jul 2015
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02509013
- Acronym / sponsor ID
- WI198103
- Conditions
- Coronary Heart Disease, Chronic Kidney Disease
- Keywords
- chronic kidney disease, stable coronary heart disease, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Aug 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 eligible sites over the country will participate. Each site will recruit patients who fit the inclusion standard in chronological order
Key inclusion criteria (5 listed)
- Age≥18 years.
- Patients with clinical evidence of stable coronary heart disease, who meet at least one of the following three criterias:
- Informed consent signed by patients or legal guardians.
- Willing to and capable of being followed up for 1 year.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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 association between CKD and cardiovascular events during one-year's follow-up
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Huo, MD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Chronic Kidney Disease, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Jiang, MD (8610-83575180, jiangjie@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of chronic kidney disease in patients with stable coronary heart disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.