Cardio-Renal SyndromeNCT02664246
Contrast-induced Nephropathy: Incidence,Risk Factors,Effective Prevention and Management Method
An observational study of Cardio-Renal Syndrome, run by Chinese PLA General Hospital.
Trial summary
This review article have included about ten thousand patients undergoing percutaneous coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new risk factors and the protecting methods for these factors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardio-Renal Syndrome
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015
Who may be able to join
- congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%;
- moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;
- patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.
Who cannot join
- hemodialysis-dependent patients;
- complicated with severe short-term progressive disease;
- Patients < 18 years;
- pregnancy;
- emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
- exposure to radiographic contrast media within the previous 7 days;
- acute decompensated heart failure.
About this study
Official title: Chinese People's Liberation Army General Hospital
This review article have included about ten thousand patients undergoing percutaneous coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new risk factors and the protecting methods for these factors.
Read the detailed description
About ten thousand patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015 are included in this study. We collect the data about the SCr of the patients before and after percutaneous coronary intervention, and define CIN as an increase in SCr of 0.5 mg/dl or 25% from baseline between 48 and 72 h after contrast medium exposure. Besides we obtain the data including clinical characteristics, laboratory data (blood and urine tests) for all the patients. The statistical analysis will find some new risk factors.
- Conditions
- Cardio-Renal Syndrome
- Being tested
- percutaneous coronary intervention
- Keywords
- contrast-induced nephropathy, Percutaneous coronary intervention, risk factors, incidence
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast induced nephropathy postoperation
peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7
Measured: 7 days
Secondary outcomes (1)
Composite measure of dialysis or main cardiovascular events
dialysis, myocardial infarction, heart failure and all-cause death
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardio-Renal SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian geng, Chinese PLA General Hospital
- Investigators
- Dai Yun Chen, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664246
- Sponsor's protocol ID
- 16qqy
- Status last verified
- Jan 2016
- First submitted
- 22 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tao SM, Wichmann JL, Schoepf UJ, Fuller SR, Lu GM, Zhang LJ. Contrast-induced nephropathy in CT: incidence, risk factors and strategies for prevention. Eur Radiol. 2016 Sep;26(9):3310-8. doi: 10.1007/s00330-015-4155-8. Epub 2015 Dec 18.
PubMed 26685852Wichmann JL, Katzberg RW, Litwin SE, Zwerner PL, De Cecco CN, Vogl TJ, Costello P, Schoepf UJ. Contrast-Induced Nephropathy. Circulation. 2015 Nov 17;132(20):1931-6. doi: 10.1161/CIRCULATIONAHA.115.014672. No abstract available.
PubMed 26572669Andreucci M, Faga T, Pisani A, Sabbatini M, Russo D, Michael A. Prevention of contrast-induced nephropathy through a knowledge of its pathogenesis and risk factors. ScientificWorldJournal. 2014;2014:823169. doi: 10.1155/2014/823169. Epub 2014 Nov 30.
PubMed 25525625Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9.
PubMed 26685074
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese People's Liberation Army General Hospital
- ClinicalTrials.gov ID
- NCT02664246
- Acronym / sponsor ID
- 16qqy
- Conditions
- Cardio-Renal Syndrome
- Keywords
- contrast-induced nephropathy, Percutaneous coronary intervention, risk factors, incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Jan 2016 (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 review article have included about ten thousand patients undergoing percutaneous coronary intervention (PCI), aim to identify the incidence of CIN in actual, find some new risk factors and the protecting methods for these factors.
Detailed description
About ten thousand patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015 are included in this study. We collect the data about the SCr of the patients before and after percutaneous coronary intervention, and define CIN as an increase in SCr of 0.5 mg/dl or 25% from baseline between 48 and 72 h after contrast medium exposure. Besides we obtain the data including clinical characteristics, laboratory data (blood and urine tests) for all the patients. The statistical analysis will find some new risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing percutaneous coronary intervention (PCI) from 2010 to 2015
Key inclusion criteria (3 listed)
- congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%;
- moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;
- patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.
Key exclusion criteria (7 listed)
- hemodialysis-dependent patients;
- complicated with severe short-term progressive disease;
- Patients < 18 years;
- pregnancy;
- emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous coronary intervention | Device | – |
Primary outcome
Contrast induced nephropathy postoperation
Time frame: 7 days
peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7
1 secondary outcome
Composite measure of dialysis or main cardiovascular events
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Background: PubMed 26685852Tao SM, Wichmann JL, Schoepf UJ, Fuller SR, Lu GM, Zhang LJ. Contrast-induced nephropathy in CT: incidence, risk factors and strategies for prevention. Eur Radiol. 2016 Sep;26(9):3310-8. doi: 10.1007/s00330-015-4155-8. Epub 2015 Dec 18.
- Background: PubMed 26572669Wichmann JL, Katzberg RW, Litwin SE, Zwerner PL, De Cecco CN, Vogl TJ, Costello P, Schoepf UJ. Contrast-Induced Nephropathy. Circulation. 2015 Nov 17;132(20):1931-6. doi: 10.1161/CIRCULATIONAHA.115.014672. No abstract available.
- Background: PubMed 25525625Andreucci M, Faga T, Pisani A, Sabbatini M, Russo D, Michael A. Prevention of contrast-induced nephropathy through a knowledge of its pathogenesis and risk factors. ScientificWorldJournal. 2014;2014:823169. doi: 10.1155/2014/823169. Epub 2014 Nov 30.
- Background: PubMed 26685074Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9.
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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.
Dai Yun Chen, MD study chair
Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio-Renal Syndrome, run by Chinese PLA General Hospital.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contrast induced nephropathy postoperation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664246, which also lists 4 linked publications.
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 27 Jan 2016.