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

Primary Purpose

Contrast-induced Nephropathy, Coronary Angiography

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Coronary Angiography
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Contrast-induced Nephropathy focused on measuring Urine Metabolomics, Contrast Induced Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Nooshin Dalili

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Developed Contrast Induced Nephropathy

Without CIN

Arm Description

Coronary Angiography

Coronary Angiography

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Urine Metabolomics
Finding differences between urine metabolites profile between patients develop CIN and without CIN

Full Information

First Posted
November 4, 2018
Last Updated
November 5, 2018
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03731962
Brief Title
Using Preprocedural Urine NMR(Nuclear Magnetic Resonance) -Based Metabolomics Analysis
Official Title
Using Preprocedural Urine NMR-Based Metabolomics Analysis to Prediction the Risk of Contrast Induced Nephropathy Following Elective Coronary Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The specific aim of this pilot study is to determine if metabolomics profiles differ in patients who develop CIN after contrast administration for coronary angiography versus those who do not. Additionally, our goal was to identify specific urinary metabolites that warrant further investigation.This is a pilot study of prospectively identified patients undergoing a coronary intervention with intraarterial contrast during their evaluation. The study was approved by the University of Shahid Beheshti, Medical institutional review boards. 100 number of patients were enrolled. To be eligible for the study, patients had to be >18 years old, undergoing coronary angiography and have at least 1 of the following high risk features for CIN: diabetes, coronary artery disease, congestive heart failure. Past medical history was confirmed by chart review if available, or patient report. Patients were excluded from the study if they had an estimated glomerular filtration rate <15 mL/min/1.73 m2, a history of organ transplantation, were currently on immunosuppressive medications, were septic or on antibiotic therapy, had a history of or were currently receiving dialysis of any type, had an exposure to iodinated contrast within 3 days prior to the study, or had multiple doses of contrast given. Patients were managed according to the treating provider recommendations. No intervention was requested as part of this study. There was no institutional standard for mandatory fluid administration or use of N-acetylcysteine prior to elective coronary angiography.All patients received approximately 60 mili Liter of intravenous iodinated contrast material that was administered via computer-controlled automated power injector at 4 mL per second. data were collected prospectively after patients were identified as fulfilling inclusion and exclusion criteria, and informed consent was obtained. Data collection included , demographics, dietary history, medical history, physical examination, and electrocardiogram findings, as documented by the treating emergency physician. Medical history was confirmed through patient self-report and review of the medical record when available. Medications administered before arrival were also recorded. No additional laboratory tests were mandated as a part of the trial study and the treating physician ordered all tests, except urinary metabolomics analysis, according to their clinical judgment. Urine samples were collected as a midstream sample or via a foley bag prior to angiography and 12 hours post imaging. Samples were aliquoted into 2 mL samples and frozen at -80˚C. Serum creatinine levels were recorded at presentation, and at 24 and 72 hours. The outcome measure was the presence CIN, which was defined as an increase in serum creatinine level of ≥0.5 mg/dL above baseline within 72 hours after contrast administration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Nephropathy, Coronary Angiography
Keywords
Urine Metabolomics, Contrast Induced Nephropathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Developed Contrast Induced Nephropathy
Arm Type
Active Comparator
Arm Description
Coronary Angiography
Arm Title
Without CIN
Arm Type
Other
Arm Description
Coronary Angiography
Intervention Type
Procedure
Intervention Name(s)
Coronary Angiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
developing CIN
Description
an increase in serum creatinine level of ≥0.5 mg/dL above baseline within 48 hours after contrast administration
Time Frame
within 48 hours after contrast administration
Secondary Outcome Measure Information:
Title
Urine Metabolomics
Description
Finding differences between urine metabolites profile between patients develop CIN and without CIN
Time Frame
within 48 hours after contrast administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients had to be >18 years old Undergoing elective coronary angiography Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalili
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nooshin Dalili
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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