Contrast-induced Acute Kidney InjuryMPCCNCT02808845
Microalbuminuria Predicting CIAKI After CAG
An observational study of Contrast-induced Acute Kidney Injury and Microalbuminuria, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the association between pre-existing microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary angiography (CAG). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Contrast-induced Acute Kidney Injury, Microalbuminuria
- What is being tested?
- microalbuminuria
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with eGFR ≥ 30 ml/min and without macroalbuminuria (defined as urine albumin to creatinine ratio (ACR) >300 mg/g) on admission are prepared to accept scheduled invasive coronary angiography during hospitalization.
Who may be able to join
- Patients with eGFR≥30ml/min and without macroalbuminuria undergoing CAG.
Who cannot join
- Pregnancy
- Lactation
- Allergic history of contrast media
- Having been received contrast media within 7 days
- Use of nephrotoxic medications within 7 days
- eGFR <30 ml/min, macroalbuminuria (ACR >300 mg/g)
Show all 11Show fewer
- Renal transplantation, emergent coronary angiography
- Cardiogenic shock, pulmonary edema
- Use of intra-aortic balloon pump (IABP) or mechanical ventilation
- Multiple myeloma and other malignant tumor
- Life expectancy less than 12 months
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Zhijian Yang, Doctor, +86 13809030208, zhijianyangnj@njmu.edu.vn
Haoyu Meng, Master, +86 15805167259, 15805167259@163.com
About this study
Official title: Pre-existing Microalbuminuria Predicting Contrast-induced Acute Kidney Injury (CIAKI) Following Coronary Angiography (CAG)
The purpose of this study is to investigate the association between pre-existing microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary angiography (CAG).
- Being tested
- microalbuminuria
- Keywords
- coronary angiography, contrast-induced acute kidney injury, microalbuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microalbuminuriaOther
| Study group | Role | What they receive |
|---|---|---|
| microalbuminuria with eGFR≥60ml/min | microalbuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min. Receives: Other: microalbuminuria | |
| normal-albuminuria group with eGFR≥60ml/min | normal-albuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min. | |
| microalbuminuria group with eGFR<60ml/min | microalbuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min. Receives: Other: microalbuminuria | |
| normal-albuminuria group with eGFR<60ml/min | normal-albuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of serum creatinine (SCr, umol/L)
the difference of SCr before and after CAG.
Measured: 24-48 hours after CAG
number of participants with increase in SCr of at least 44.2 umol/L higher than before
number of participants with the difference of SCr before and after CAG over 44.2 umol/L.
Measured: 24-48 hours after CAG
number of participants with increase of SCr over 25% higher than before
number of participants with an increase of SCr over 25% higher than before.
Measured: 24-48 hours after CAG
Secondary outcomes (1)
changes of urine albumin to creatinine ratio (ACR, mg/g)
the difference of ACR before and after CAG
Measured: 24-48 hours after CAG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Contrast-induced Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhijian Yang, Doctor, Study chair, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808845
- Sponsor's protocol ID
- CIAKI-1
- Acronym
- MPCC
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
Publications
Pucelikova T, Dangas G, Mehran R. Contrast-induced nephropathy. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):62-72. doi: 10.1002/ccd.21207.
PubMed 17975790Jo SH, Youn TJ, Koo BK, Park JS, Kang HJ, Cho YS, Chung WY, Joo GW, Chae IH, Choi DJ, Oh BH, Lee MM, Park YB, Kim HS. Renal toxicity evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in patients with renal insufficiency undergoing coronary angiography: the RECOVER study: a randomized controlled trial. J Am Coll Cardiol. 2006 Sep 5;48(5):924-30. doi: 10.1016/j.jacc.2006.06.047. Epub 2006 Aug 17.
PubMed 16949481Marenzi G, Assanelli E, Campodonico J, Lauri G, Marana I, De Metrio M, Moltrasio M, Grazi M, Rubino M, Veglia F, Fabbiocchi F, Bartorelli AL. Contrast volume during primary percutaneous coronary intervention and subsequent contrast-induced nephropathy and mortality. Ann Intern Med. 2009 Feb 3;150(3):170-7. doi: 10.7326/0003-4819-150-3-200902030-00006.
PubMed 19189906Rihal CS, Textor SC, Grill DE, Berger PB, Ting HH, Best PJ, Singh M, Bell MR, Barsness GW, Mathew V, Garratt KN, Holmes DR Jr. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation. 2002 May 14;105(19):2259-64. doi: 10.1161/01.cir.0000016043.87291.33.
PubMed 12010907Cronin RE. Contrast-induced nephropathy: pathogenesis and prevention. Pediatr Nephrol. 2010 Feb;25(2):191-204. doi: 10.1007/s00467-009-1204-z. Epub 2009 May 15.
PubMed 19444480National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577Lambers Heerspink HJ, Brinkman JW, Bakker SJ, Gansevoort RT, de Zeeuw D. Update on microalbuminuria as a biomarker in renal and cardiovascular disease. Curr Opin Nephrol Hypertens. 2006 Nov;15(6):631-6. doi: 10.1097/01.mnh.0000247496.54882.3f.
PubMed 17053479Stehouwer CD, Smulders YM. Microalbuminuria and risk for cardiovascular disease: Analysis of potential mechanisms. J Am Soc Nephrol. 2006 Aug;17(8):2106-11. doi: 10.1681/ASN.2005121288. Epub 2006 Jul 6.
PubMed 16825333Baber U, Mann D, Shimbo D, Woodward M, Olin JW, Muntner P. Combined role of reduced estimated glomerular filtration rate and microalbuminuria on the prevalence of peripheral arterial disease. Am J Cardiol. 2009 Nov 15;104(10):1446-51. doi: 10.1016/j.amjcard.2009.06.068.
PubMed 19892066Bakris GL, Ruilope L, Locatelli F, Ptaszynska A, Pieske B, de Champlain J, Weber MA, Raz I. Treatment of microalbuminuria in hypertensive subjects with elevated cardiovascular risk: results of the IMPROVE trial. Kidney Int. 2007 Oct;72(7):879-85. doi: 10.1038/sj.ki.5002455. Epub 2007 Aug 1.
PubMed 17667984Sany D, Refaat H, Elshahawy Y, Mohab A, Ezzat H. Frequency and risk factors of contrast-induced nephropathy after cardiac catheterization in type II diabetic patients: a study among Egyptian patients. Ren Fail. 2014 Mar;36(2):191-7. doi: 10.3109/0886022X.2013.843400. Epub 2013 Oct 21.
PubMed 24138570Meng H, Wu P, Zhao Y, Xu Z, Wang ZM, Li C, Wang L, Yang Z. Microalbuminuria in patients with preserved renal function as a risk factor for contrast-Induced acute kidney injury following invasive coronary angiography. Eur J Radiol. 2016 Jun;85(6):1063-7. doi: 10.1016/j.ejrad.2016.03.010. Epub 2016 Mar 16.
PubMed 27161053
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-existing Microalbuminuria Predicting Contrast-induced Acute Kidney Injury (CIAKI) Following Coronary Angiography (CAG)
- ClinicalTrials.gov ID
- NCT02808845
- Acronym / sponsor ID
- MPCC / CIAKI-1
- Keywords
- coronary angiography, contrast-induced acute kidney injury, microalbuminuria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2020 (estimated)
- First posted
- 22 Jun 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.
The purpose of this study is to investigate the association between pre-existing microalbuminuria and contrast-induced acute kidney injury (CIAKI) following coronary angiography (CAG).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| microalbuminuria with eGFR≥60ml/min | – | Other: microalbuminuriamicroalbuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min. |
| normal-albuminuria group with eGFR≥60ml/min | – | –normal-albuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min. |
| microalbuminuria group with eGFR<60ml/min | – | Other: microalbuminuriamicroalbuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min. |
| normal-albuminuria group with eGFR<60ml/min | – | –normal-albuminuria group with estimated glomerular filtration rate (eGFR) <60ml/min. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with eGFR ≥ 30 ml/min and without macroalbuminuria (defined as urine albumin to creatinine ratio (ACR) >300 mg/g) on admission are prepared to accept scheduled invasive coronary angiography during hospitalization.
Key inclusion criteria (1 listed)
- Patients with eGFR≥30ml/min and without macroalbuminuria undergoing CAG.
Key exclusion criteria (11 listed)
- Pregnancy
- Lactation
- Allergic history of contrast media
- Having been received contrast media within 7 days
- Use of nephrotoxic medications within 7 days
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 |
|---|---|---|
| microalbuminuria | Other | microalbuminuria group with eGFR<60ml/min, microalbuminuria with eGFR≥60ml/min |
Primary outcome
changes of serum creatinine (SCr, umol/L)
Time frame: 24-48 hours after CAG
the difference of SCr before and after CAG.
number of participants with increase in SCr of at least 44.2 umol/L higher than before
Time frame: 24-48 hours after CAG
number of participants with the difference of SCr before and after CAG over 44.2 umol/L.
number of participants with increase of SCr over 25% higher than before
Time frame: 24-48 hours after CAG
number of participants with an increase of SCr over 25% higher than before.
1 secondary outcome
changes of urine albumin to creatinine ratio (ACR, mg/g)
Time frame: 24-48 hours after CAG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Background: PubMed 17975790Pucelikova T, Dangas G, Mehran R. Contrast-induced nephropathy. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):62-72. doi: 10.1002/ccd.21207.
- Background: PubMed 16949481Jo SH, Youn TJ, Koo BK, Park JS, Kang HJ, Cho YS, Chung WY, Joo GW, Chae IH, Choi DJ, Oh BH, Lee MM, Park YB, Kim HS. Renal toxicity evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in patients with renal insufficiency undergoing coronary angiography: the RECOVER study: a randomized controlled trial. J Am Coll Cardiol. 2006 Sep 5;48(5):924-30. doi: 10.1016/j.jacc.2006.06.047. Epub 2006 Aug 17.
- Background: PubMed 19189906Marenzi G, Assanelli E, Campodonico J, Lauri G, Marana I, De Metrio M, Moltrasio M, Grazi M, Rubino M, Veglia F, Fabbiocchi F, Bartorelli AL. Contrast volume during primary percutaneous coronary intervention and subsequent contrast-induced nephropathy and mortality. Ann Intern Med. 2009 Feb 3;150(3):170-7. doi: 10.7326/0003-4819-150-3-200902030-00006.
- Background: PubMed 12010907Rihal CS, Textor SC, Grill DE, Berger PB, Ting HH, Best PJ, Singh M, Bell MR, Barsness GW, Mathew V, Garratt KN, Holmes DR Jr. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation. 2002 May 14;105(19):2259-64. doi: 10.1161/01.cir.0000016043.87291.33.
- Background: PubMed 19444480Cronin RE. Contrast-induced nephropathy: pathogenesis and prevention. Pediatr Nephrol. 2010 Feb;25(2):191-204. doi: 10.1007/s00467-009-1204-z. Epub 2009 May 15.
- Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- Background: PubMed 17053479Lambers Heerspink HJ, Brinkman JW, Bakker SJ, Gansevoort RT, de Zeeuw D. Update on microalbuminuria as a biomarker in renal and cardiovascular disease. Curr Opin Nephrol Hypertens. 2006 Nov;15(6):631-6. doi: 10.1097/01.mnh.0000247496.54882.3f.
- Background: PubMed 16825333Stehouwer CD, Smulders YM. Microalbuminuria and risk for cardiovascular disease: Analysis of potential mechanisms. J Am Soc Nephrol. 2006 Aug;17(8):2106-11. doi: 10.1681/ASN.2005121288. Epub 2006 Jul 6.
- Background: PubMed 19892066Baber U, Mann D, Shimbo D, Woodward M, Olin JW, Muntner P. Combined role of reduced estimated glomerular filtration rate and microalbuminuria on the prevalence of peripheral arterial disease. Am J Cardiol. 2009 Nov 15;104(10):1446-51. doi: 10.1016/j.amjcard.2009.06.068.
- Background: PubMed 17667984Bakris GL, Ruilope L, Locatelli F, Ptaszynska A, Pieske B, de Champlain J, Weber MA, Raz I. Treatment of microalbuminuria in hypertensive subjects with elevated cardiovascular risk: results of the IMPROVE trial. Kidney Int. 2007 Oct;72(7):879-85. doi: 10.1038/sj.ki.5002455. Epub 2007 Aug 1.
- Background: PubMed 24138570Sany D, Refaat H, Elshahawy Y, Mohab A, Ezzat H. Frequency and risk factors of contrast-induced nephropathy after cardiac catheterization in type II diabetic patients: a study among Egyptian patients. Ren Fail. 2014 Mar;36(2):191-7. doi: 10.3109/0886022X.2013.843400. Epub 2013 Oct 21.
- Results publication: PubMed 27161053Meng H, Wu P, Zhao Y, Xu Z, Wang ZM, Li C, Wang L, Yang Z. Microalbuminuria in patients with preserved renal function as a risk factor for contrast-Induced acute kidney injury following invasive coronary angiography. Eur J Radiol. 2016 Jun;85(6):1063-7. doi: 10.1016/j.ejrad.2016.03.010. Epub 2016 Mar 16.
- Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAGLink provided by the sponsor.
- Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAGLink provided by the sponsor.
- Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAGLink provided by the sponsor.
- Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAGLink provided by the sponsor.
- Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAGLink provided by the sponsor.
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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.
Zhijian Yang, Doctor study chair
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province 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 Acute Kidney Injury and Microalbuminuria, run by The First Affiliated Hospital with Nanjing Medical University 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 1 inclusion and 11 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 22 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 Zhijian Yang, Doctor (+86 13809030208, zhijianyangnj@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of serum creatinine (SCr, umol/L) (time frame: 24-48 hours after CAG). The study lists 3 primary outcomes in all. 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 NCT02808845, which also lists 12 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 22 Jun 2016.