Using Preprocedural Urine NMR(Nuclear Magnetic Resonance) -Based Metabolomics Analysis

NCT03731962 | Completed DMC

• 1 other identifier: SBMU23567/J
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The use of coronary intervention has increased over the last decade. Contrast induced nephropathy (CIN) that develops as a result of procedures using intravenous or intra arterial contrast enhancement, or other diagnostic procedures, has been reported to be the third leading cause of acute renal failure in hospitalized patients. It has been hypothesized that this occurs as a result of direct toxicity, oxidative stress, and ischemic injury. Numerous studies have evaluated the incidence of CIN in patients undergoing angiography. There are limited studies in the acute care setting. Therefore, a tool that could identify early risk factors for CIN would be valuable for patient care. Metabolomic profiling is the identification of small molecule metabolites that are altered in response to injury. We hypothetize that urine metabolomic profiles may differ in patients before and after contrast administration coronary intervention.We hypothesized that metabolomic profiles will differ between those patients who develop CIN and those who do not after contrast administration. In addition we believe that metabolomics profiles prior to angiography may identify subjects who will go on to develop CIN and are therefore at higher risk.

Conditions

Contrast-induced Nephropathy; Coronary Angiography

Keywords

Urine Metabolomics; Contrast Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• developing CIN

  an increase in serum creatinine level of ≥0.5 mg/dL above baseline within 48 hours after contrast administration

  within 48 hours after contrast administration

Secondary Outcomes (1)

• Urine Metabolomics

  within 48 hours after contrast administration

Study Arms (2)

Developed Contrast Induced Nephropathy

ACTIVE COMPARATOR

Coronary Angiography

Procedure: Coronary Angiography

Without CIN

OTHER

Coronary Angiography

Procedure: Coronary Angiography

Interventions

Coronary Angiography PROCEDURE

All patients received approximately 60 mL of intra arterial iodinated contrast material that was administered via computer-controlled automated power injector at 4 mL per second.

Developed Contrast Induced Nephropathy; Without CIN

Eligibility Criteria

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

You may qualify if:

• patients had to be \>18 years old Undergoing elective coronary angiography

You may not qualify if:

• estimated glomerular filtration rate \<15 mL/min/1.73 m2
• history of organ transplantation
• using immunosuppressive medications
• septic patients or on antibiotic therapy
• a history of receiving dialysis of any type
• an exposure to iodinated contrast within 3 days prior to the study

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Nooshin Dalili

Tehran, Iran

Location

Study Officials

• Dalili

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 6, 2018
• Study Start: August 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)