Microalbuminuria Predicting CIAKI After CAG

NCT02808845 | Unknown

• 1 other identifier: CIAKI-1
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Contrast-induced Acute Kidney Injury; Microalbuminuria

Keywords

coronary angiography; contrast-induced acute kidney injury; microalbuminuria

Outcome Measures

Primary Outcomes (3)

• changes of serum creatinine (SCr, umol/L)

  the difference of SCr before and after CAG.

  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.

  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.

  24-48 hours after CAG

Secondary Outcomes (1)

• changes of urine albumin to creatinine ratio (ACR, mg/g)

  24-48 hours after CAG

Study Arms (4)

microalbuminuria with eGFR≥60ml/min

microalbuminuria group with estimated glomerular filtration rate (eGFR) ≥60ml/min.

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.

Other: microalbuminuria

normal-albuminuria group with eGFR<60ml/min

normal-albuminuria group with estimated glomerular filtration rate (eGFR) \<60ml/min.

Interventions

microalbuminuria OTHER

microalbuminuria group with eGFR<60ml/min; microalbuminuria with eGFR≥60ml/min

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients with eGFR≥30ml/min and without macroalbuminuria undergoing CAG.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (12)

• Pucelikova T, Dangas G, Mehran R. Contrast-induced nephropathy. Catheter Cardiovasc Interv. 2008 Jan 1;71(1):62-72. doi: 10.1002/ccd.21207.

  PMID: 17975790 BACKGROUND

• 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. doi: 10.1016/j.jacc.2006.06.047. Epub 2006 Aug 17.

  PMID: 16949481 BACKGROUND

• 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. doi: 10.7326/0003-4819-150-3-200902030-00006.

  PMID: 19189906 BACKGROUND

• 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. doi: 10.1161/01.cir.0000016043.87291.33.

  PMID: 12010907 BACKGROUND

• 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.

  PMID: 19444480 BACKGROUND

• 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. No abstract available.

  PMID: 11904577 BACKGROUND

• 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. doi: 10.1097/01.mnh.0000247496.54882.3f.

  PMID: 17053479 BACKGROUND

• Stehouwer 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.

  PMID: 16825333 BACKGROUND

• 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.

  PMID: 19892066 BACKGROUND

• 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. doi: 10.1038/sj.ki.5002455. Epub 2007 Aug 1.

  PMID: 17667984 BACKGROUND

• 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.

  PMID: 24138570 BACKGROUND

• 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. doi: 10.1016/j.ejrad.2016.03.010. Epub 2016 Mar 16.

  PMID: 27161053 RESULT

Related Links

• Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAG
• Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAG
• Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAG
• Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAG
• Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAG
• Click here for more information about this study: Microalbuminuria Predicting CIAKI After CAG

Study Officials

• Zhijian Yang, Doctor

  First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

  STUDY CHAIR

Central Study Contacts

Zhijian Yang, Doctor

CONTACT

+86 13809030208; zhijianyangnj@njmu.edu.cn

Haoyu Meng, Master

CONTACT

+86 15805167259; 15805167259@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 22, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Last Updated: June 22, 2016

Record last verified: 2016-06

Locations

CN (1)