Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial

Contrast Induced Nephropathy Clinical Trial

— ACTIN  

Official title:

Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650336
• Other study ID #: ACTIN-sysu
• Status: Completed
• Phase: N/A
• First received: January 3, 2016
• Last updated: January 6, 2016
• Start date: October 2013
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Observational

Clinical Trial Summary

Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results. The investigators explored the association between plasma aging biomakers such as sklotho and contrast induced nephropathy in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.

Description:

Acute kidney injury represents an important clinical problem in hospitalized patients, with persistently high rates of mortality and morbidity. With an ever-increasing number of patients receiving intravascular injection of iodinated contrast media worldwide, contrast induced nephropathy (CIN) has become the third leading cause of hospital-acquired AKI. Approximately half of these cases are in patients undergoing cardiac catheterization procedures.

The prevention and early intervention of CIN has been hampered mainly by the lack of a consensus definition and the paucity of early predictive biomarkers to accurately identify high-risk patients. CIN is most frequently defined as an increase in serum creatinine (sCr) by 25-50% above the baseline, generally occurring within the first 24 h after contrast exposure, in the absence of other causes. However, sCr is an unreliable indicator during acute changes in kidney function, and alterations in sCr levels are not particularly sensitive or specific for small changes in the glomerular filtration rate (GFR)e, gender, race and intravascular volume. Biomarkers such as kidney injury molecule-1 (KIM-1) and neutrophil gelatinase-associated lipocalin (NGAL) have been used for the early diagnosis of AKI, although with no definitive results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older undergoing planed PCI were prospectively recruited

Exclusion Criteria:

• Pregnancy

• Lactation

• Sepsis

• The intravascular administration of a contrast medium within the past 7 days, nephroprotective drug treatment (e.g., N-acetylcysteine, theophylline, sodium bicarbonate, prostaglandin E1)

• Nephrotoxic drug intake (e.g., non-steroidal anti-inflammatory drugs, metformin, aminoglycosides, cisplatin) within the past 7 days

• A history of serious allergic to contrast media

• Renal transplantation

• End-stage renal disease necessitating dialysis

• Severe concomitant disease of other systems.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contrast Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• contrast
a substance used to enhance the contrast of structures or fluids within the body in medical imaging. It is commonly used to enhance the visibility of blood vessels and the gastrointestinal tract

Locations

Country	Name	City	State
China	Xiaodong Zhaung	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The association between plasma aging biomakers and contrast induced nephropathy	The plasma concentrations human soluble a-Klotho levels were measured by Enzyme Linked Immunosorbent Assay (ELISA) (Immuno-Biologic Laboratories Co., Ltd. Japan). This novel method detects sklotho using a monoclonal antibody with high affinity to the human a-Klotho protein.Hs-CRP was tested with a Beckman Coulter Immage immunobiochemistry system (USA) using nephelometry (unit: mg/L). Creatinine clearance (CrCl) was calculated by applying the Cockcroft- Gault formula to the serum creatinine concentration.	48-72 hours	No
Secondary	The association between plasma aging biomakers and in-hospital MACE in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.	In-hospital major adverse cardiovascular events (MACE):defined as (1) death, (2) nonfatal myocardial infarction, or (3) target vessel revascularization. Myocardial infarction was diagnosed by a rise in the creatine kinase level to more than twice the upper normal limit with an increased creatine kinase-MB. Target lesion revascularization was defined as a repeat intervention (surgical or percutaneous) to treat a luminal stenosis within the stent or in the 5-mm distal or proximal segments adjacent to the stent. Target vessel revascularization was defined as a reintervention driven by any lesion located in the same epicardial vessel. Thrombotic stent occlusion was angiographically documented as a complete occlusion (TIMI flow 0 or 1) or a flow-limiting thrombus (TIMI flow 1 or 2) of a previously successfully treated artery.	30 days, 1 year	No