PREdictive Value of COntrast voluMe to creatinINe Clearance Ratio

NCT01400295 | Completed DMC

• 1 other identifier: 20100917
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Contrast Induced Nephropathy

Keywords

contrast-induced nephropathy; contrast medium; creatinine clearance; coronary angiography; diabetes; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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

  48-72 h

Secondary Outcomes (4)

• An early abnormal increase in serum creatinine

  24h

• Major adverse clinical events

  1 year

• Major adverse clinical events

  1month

• An early abnormal increase in serum cystatin C

  24h

Study Arms (1)

coronary angiography

The investigators reviewed all consecutive patients who were undergoing coronary angiography

Eligibility Criteria

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

Study Population

The investigators reviewed all consecutive patients who were undergoing coronary angiography

You may qualify if:

• patients who agreed to stay in the hospital for 2-3 days after coronary angiography
• provided written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Cardiovascular Institute,Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (4)

• 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.

  PMID: 32867690 DERIVED

• Liu 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.

  PMID: 32285318 DERIVED

• Liu 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.

  PMID: 31179103 DERIVED

• Guo 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.

  PMID: 28866117 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiyan Chen, MD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  STUDY CHAIR

• Yong Liu, MD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  STUDY DIRECTOR

• Yingling Zhou, MD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  STUDY DIRECTOR

• Ning Tan, MD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  STUDY DIRECTOR

• Jianfang Luo, MD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 22, 2011
• Study Start: December 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 16, 2014

Record last verified: 2014-09

Locations

CN (1)