Aging Biomakers and ConTrast Induced Nephropathy (ACTIN) Trial

NCT02650336 | Completed

• 1 other identifier: ACTIN-sysu
• Study Type: observational
• Target: 592
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The association between plasma aging biomakers and in-hospital MACE in patients undergoing percutaneous coronary intervention (PCI) with contrast injection.

  30 days, 1 year

Study Arms (2)

CIN proup

The occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure.

Drug: contrast

control group

The occurrence of CIN was defined as an increase in serum creatinine of 0.5 mg/dL above the baseline value within 48-72 h after PCI. Follow-up SCr and BUN levels were measured 1, 2, and 3 days after the procedure.

Drug: contrast

Interventions

contrast DRUG

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

Also known as: low-osmolar, non-ionic contrast medium

CIN proup; control group

Eligibility Criteria

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

Study Population

Patients aged 18 years or older undergoing planed PCI at the institution of first affiliated hospital of SYSU were prospectively recruited between May 2014 and July 2015. The exclusion criteria were 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, and severe concomitant disease of other systems.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Xiaodong Zhaung

Guangzhou, Guangdong, 510080, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Morning blood samples were received from all volunteers after an 8-h overnight fast. The investigators obtained the blood samples used to measure preoperative serum uric acid, baseline serum creatinine (SCr) (prior to the pre-procedural hydration), blood urea nitrogen (BUN), fasting blood glucose, random blood glucose, electrolytes before PCI, serum lipids, albumin, hemoglobin, and other standard clinical parameters. Blood samples were left to clot for one hour and then centrifuged at 1500 ×g for 10 min. Plasma samples were accumulated and stored at -80 °C until analysis.

MeSH Terms

Interventions

Contrast Media

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• zhimin du, MD

  fitst affiliated hospital of SYSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of cardiology, first affiliated hoapital of SYSU

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: January 8, 2016
• Study Start: October 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)