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Contrast-induced NephropathyNCT03731962

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

A study testing Coronary Angiography in people with Contrast-induced Nephropathy and Coronary Angiography, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary Angiography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIran
Study dates
1 Aug 2018to 1 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site
  • Nooshin Dalili

    Tehran

Other trials in Iran

About this study

Official title: Using Preprocedural Urine NMR-Based Metabolomics Analysis to Prediction the Risk of Contrast Induced Nephropathy Following Elective Coronary Angiography

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.

Read the 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.

Being tested
Coronary Angiography
Keywords
Urine Metabolomics, Contrast Induced Nephropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary AngiographyProcedure or surgery

    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.

Study groups in NCT03731962
Study groupRoleWhat they receive
Developed Contrast Induced NephropathyActive comparatorCoronary Angiography
Receives: Procedure: Coronary Angiography
Without CINOtherCoronary Angiography
Receives: Procedure: Coronary Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. developing CIN

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

    Measured: within 48 hours after contrast administration

Secondary outcomes (1)
  1. Urine Metabolomics

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

    Measured: within 48 hours after contrast administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2018
  2. Study start1 Aug 2018
  3. Primary completion1 Sep 2018
  4. Study completion1 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03731962
Sponsor's protocol ID
SBMU23567/J
Status last verified
Nov 2018
First submitted
4 Nov 2018
Last updated
7 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Angiography in people with Contrast-induced Nephropathy and Coronary Angiography, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

developing CIN (time frame: within 48 hours after contrast administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.

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