Microalbuminuria Clinical Trial
— MPCCOfficial title:
Pre-existing Microalbuminuria Predicting Contrast-induced Acute Kidney Injury (CIAKI) Following Coronary Angiography (CAG)
| NCT number | NCT02808845 |
| Other study ID # | CIAKI-1 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | June 13, 2016 |
| Last updated | June 21, 2016 |
| Start date | December 2016 |
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).
| Status | Not yet recruiting |
| Enrollment | 800 |
| Est. completion date | |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients with eGFR=30ml/min and without macroalbuminuria undergoing CAG. Exclusion Criteria: - 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) - 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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| China | First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital with Nanjing Medical University |
China,
Baber 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. — View Citation
Bakris 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. Epub 2007 Aug 1. — View Citation
Cronin 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. Review. — View Citation
Jo 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. Epub 2006 Aug 17. — View Citation
Lambers 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. Review. — View Citation
Marenzi 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. — View Citation
Meng 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. d — View Citation
National 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. — View Citation
Pucelikova T, Dangas G, Mehran R. Contrast-induced nephropathy. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):62-72. Review. — View Citation
Rihal 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. — View Citation
Sany 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. — View Citation
Stehouwer CD, Smulders YM. Microalbuminuria and risk for cardiovascular disease: Analysis of potential mechanisms. J Am Soc Nephrol. 2006 Aug;17(8):2106-11. Epub 2006 Jul 6. — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | changes of serum creatinine (SCr, umol/L) | the difference of SCr before and after CAG. | 24-48 hours after CAG | Yes |
| Primary | 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. | 24-48 hours after CAG | Yes |
| Primary | 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. | 24-48 hours after CAG | Yes |
| Secondary | changes of urine albumin to creatinine ratio (ACR, mg/g) | the difference of ACR before and after CAG | 24-48 hours after CAG | Yes |
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