Contrast Induced NephropathyPRECOMINNCT01400295
PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio
An observational study of Contrast Induced Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
To determine a relatively safe contrast media volume to creatinine clearance cut-off value to avoid contrast-induced nephropathy in patients following coronary angiography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Nephropathy
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Sep 2013
- 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: The investigators reviewed all consecutive patients who were undergoing coronary angiography
Who may be able to join
- patients who agreed to stay in the hospital for 2-3 days after coronary angiography
- provided written informed consent
Who cannot join
- pregnancy
- lactation
- intravascular administration of an contrast medium within the previous seven days
- treatment with metformin,aminoglycosides,N-acetylcysteine (NAC),nonsteroidal anti-inflammatory drugs within the previous 48 h
- intake of nephrotoxic drugs within the previous seven days
- history of serious reactions to contrast mediums， severe concomitant disease renal transplantation , or end-stage renal disease necessitating dialysis
- patients who died during coronary angiography
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Cardiovascular Institute,Guangdong General Hospital
Guangzhou, Guangdong, 510080
About this study
Official title: Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography
To determine a relatively safe contrast media volume to creatinine clearance cut-off value to avoid contrast-induced nephropathy in patients following coronary angiography
Read the detailed description
Contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after coronary angiography. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of contrast-induced nephropathy was assessed using multivariate logistic regression.Subgroup analysis was performed on patients with creatinine clearance < 60 ml/min,diabetes,emergent angiography.
- Conditions
- Contrast Induced Nephropathy
- Keywords
- contrast-induced nephropathy, contrast medium, creatinine clearance, coronary angiography, diabetes, chronic kidney disease
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| coronary angiography | The investigators reviewed all consecutive patients who were undergoing coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-Induced Nephropathy
Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure
Measured: 48-72 h
Secondary outcomes (4)
An early abnormal increase in serum creatinine
An early abnormal increase in serum creatinine defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 24h of contrast exposure
Measured: 24h
Major adverse clinical events
Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke
Measured: 1 year
Major adverse clinical events
Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke
Measured: 1month
An early abnormal increase in serum cystatin C
An early abnormal increase in serum cystatin C was defined as an increase more than 10% from the baseline within 24h of contrast exposure
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionSep 2013
- Study completionSep 2013
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 Contrast Induced NephropathyStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyan Chen, Guangdong Provincial People's Hospital
- Investigators
- Jiyan Chen, MD, Study chair, Guangdong Cardiovascular Institute,Guangdong General HospitalYong Liu, MD, Study director, Guangdong Cardiovascular Institute,Guangdong General HospitalYingling Zhou, MD, Study director, Guangdong Cardiovascular Institute,Guangdong General HospitalNing Tan, MD, Study director, Guangdong Cardiovascular Institute,Guangdong General HospitalJianfang Luo, MD, Principal investigator, Guangdong Cardiovascular Institute,Guangdong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400295
- Sponsor's protocol ID
- 20100917
- Acronym
- PRECOMIN
- Status last verified
- Sep 2014
- First submitted
- 21 Jul 2011
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liu L, Liu J, Lei L, Wang B, Sun G, Guo Z, He Y, Song F, Lun Z, Liu B, Chen G, Chen S, Yang Y, Liu Y, Chen J. A prediction model of contrast-associated acute kidney injury in patients with hypoalbuminemia undergoing coronary angiography. BMC Cardiovasc Disord. 2020 Aug 31;20(1):399. doi: 10.1186/s12872-020-01689-6.
PubMed 32867690Liu Y, Chen S, Ye J, Xian Y, Wang X, Xuan J, Tan N, Li Q, Chen J, Ni Z. Random forest for prediction of contrast-induced nephropathy following coronary angiography. Int J Cardiovasc Imaging. 2020 Jun;36(6):983-991. doi: 10.1007/s10554-019-01730-6. Epub 2020 Apr 13.
PubMed 32285318Liu J, Sun G, He Y, Song F, Chen S, Guo Z, Liu B, Lei L, He L, Chen J, Tan N, Liu Y. Early beta-blockers administration might be associated with a reduced risk of contrast-induced acute kidney injury in patients with acute myocardial infarction. J Thorac Dis. 2019 Apr;11(4):1589-1596. doi: 10.21037/jtd.2019.04.65.
PubMed 31179103Guo XS, Chen SQ, Duan CY, Li HL, Bei WJ, Liu Y, Tan N, Chen PY, Chen JY. Association of post-procedural early (within 24h) increases in serum creatinine with all-cause mortality after coronary angiography. Clin Chim Acta. 2017 Nov;474:96-101. doi: 10.1016/j.cca.2017.08.036. Epub 2017 Sep 1.
PubMed 28866117
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Contrast Media Volume to Creatinine Clearance Ratio for the Risk of Contrast-Induced Nephropathy After Coronary Angiography
- ClinicalTrials.gov ID
- NCT01400295
- Acronym / sponsor ID
- PRECOMIN / 20100917
- Conditions
- Contrast Induced Nephropathy
- Keywords
- contrast-induced nephropathy, contrast medium, creatinine clearance, coronary angiography, diabetes, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Jul 2011 (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.
To determine a relatively safe contrast media volume to creatinine clearance cut-off value to avoid contrast-induced nephropathy in patients following coronary angiography
Detailed description
Contrast media volume to creatinine clearance (V/CrCl) ratios were obtained from consecutive consenting patients after coronary angiography. Receiver-operator characteristic (ROC) curves were used to identify the optimal sensitivity for the observed range of V/CrCl. The predictive value of V/CrCl for the risk of contrast-induced nephropathy was assessed using multivariate logistic regression.Subgroup analysis was performed on patients with creatinine clearance < 60 ml/min,diabetes,emergent angiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary angiography | – | –The investigators reviewed all consecutive patients who were undergoing coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators reviewed all consecutive patients who were undergoing coronary angiography
Key inclusion criteria (2 listed)
- patients who agreed to stay in the hospital for 2-3 days after coronary angiography
- provided written informed consent
Key exclusion criteria (7 listed)
- pregnancy
- lactation
- intravascular administration of an contrast medium within the previous seven days
- treatment with metformin,aminoglycosides,N-acetylcysteine (NAC),nonsteroidal anti-inflammatory drugs within the previous 48 h
- intake of nephrotoxic drugs within the previous seven days
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
Contrast-Induced Nephropathy
Time frame: 48-72 h
Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure
4 secondary outcomes
An early abnormal increase in serum creatinine
Time frame: 24h
Major adverse clinical events
Time frame: 1 year
Major adverse clinical events
Time frame: 1month
An early abnormal increase in serum cystatin C
Time frame: 24h
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 16 Sep 2014.
- Derived from this study: PubMed 32867690Liu L, Liu J, Lei L, Wang B, Sun G, Guo Z, He Y, Song F, Lun Z, Liu B, Chen G, Chen S, Yang Y, Liu Y, Chen J. A prediction model of contrast-associated acute kidney injury in patients with hypoalbuminemia undergoing coronary angiography. BMC Cardiovasc Disord. 2020 Aug 31;20(1):399. doi: 10.1186/s12872-020-01689-6.
- Derived from this study: PubMed 32285318Liu Y, Chen S, Ye J, Xian Y, Wang X, Xuan J, Tan N, Li Q, Chen J, Ni Z. Random forest for prediction of contrast-induced nephropathy following coronary angiography. Int J Cardiovasc Imaging. 2020 Jun;36(6):983-991. doi: 10.1007/s10554-019-01730-6. Epub 2020 Apr 13.
- Derived from this study: PubMed 31179103Liu J, Sun G, He Y, Song F, Chen S, Guo Z, Liu B, Lei L, He L, Chen J, Tan N, Liu Y. Early beta-blockers administration might be associated with a reduced risk of contrast-induced acute kidney injury in patients with acute myocardial infarction. J Thorac Dis. 2019 Apr;11(4):1589-1596. doi: 10.21037/jtd.2019.04.65.
- Derived from this study: PubMed 28866117Guo XS, Chen SQ, Duan CY, Li HL, Bei WJ, Liu Y, Tan N, Chen PY, Chen JY. Association of post-procedural early (within 24h) increases in serum creatinine with all-cause mortality after coronary angiography. Clin Chim Acta. 2017 Nov;474:96-101. doi: 10.1016/j.cca.2017.08.036. Epub 2017 Sep 1.
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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.
Jiyan Chen, MD study chair
Guangdong Cardiovascular Institute,Guangdong General Hospital
Yong Liu, MD study director
Guangdong Cardiovascular Institute,Guangdong General Hospital
Yingling Zhou, MD study director
Guangdong Cardiovascular Institute,Guangdong General 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 Contrast Induced Nephropathy, run by Guangdong Provincial People's 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 2 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 16 Sep 2014. 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?
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 (time frame: 48-72 h). 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 NCT01400295, 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 16 Sep 2014.