NCT04225013

Brief Summary

Renal damage due to contrast media (CM) administration is one of the main complications of cardiac intervention and is called contrast-induced nephropathy (CIN). Patients suffering from CIN have a high probability of developing acute renal failure. Today there is no treatment capable of reversing kidney damage, so the best strategy is prevention, by early diagnosis. In this regard, a line of research is currently being carried out focused on the identification of new markers capable of detecting susceptibility/predisposition to renal damage before the administration of a potentially nephrotoxic drug, even at doses that alone should not produce Kidney damage. This concept has been called predisposition to kidney damage. Taking into account all of the above, the objective of this work is to evaluate the ability of the new markers (previously identified in preclinical models) to detect the predisposition to the CIN before administering the CM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

January 8, 2020

Last Update Submit

September 23, 2024

Conditions

Kidney InjuryContrast-induced Nephropathy

Keywords

BiomarkerContrast-MediaNephrotoxicityPreventionDiagnosis

Outcome Measures

Primary Outcomes (5)

  • Urinary N-acetyl-beta-D-glucosaminidase

    It is an enzyme whose urinary excretion is elevated in case of kidney damage. It is capable of detecting damage before the classic plasma creatinine and urea markers. There are no reference values for humans, so the means of patients who do not develop contrast-induced nephropathy (Control group) should be compared with those who develop the damage (Case group)

    Time 0: before administration of the contrast media

  • Urinary Kidney Injury Molecule -1

    It is a biomarker of early kidney damage. It is able to detect kidney damge in early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of patients who do not develop contrast-induced nephropathy (Control group) should be compared with those who develop the damage (Case group)

    Time 0: before administration of the contrast media

  • Urinary Neutrophil gelatinase-associated lipocalin (NGAL)

    It is a biomarker of early kidney damage. It is able to detect kidney damge in early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of patients who do not develop contrast-induced nephropathy (Control group) should be compared with those who develop the damage (Case group)

    Time 0: before administration of the contrast media

  • Urinary albumin

    It is a biomarker of early kidney damage. It is able to detect kidney damge in early stages, before the clinical markers creatinine and plasma urea. There are no reference values for humans, so the means of patients who do not develop contrast-induced nephropathy (Control group) should be compared with those who develop the damage (Case group)

    Time 0: before administration of the contrast media

  • Urinary biomarkers of predisposition to kidney injury

    It is a group of markers thar are in patent phase so their names can not be mentioned. They are able to detect the susceptibility to kidney damage before administering a nephrotoxic agent. There are no reference values for humans, so the means of patients who do not develop contrast-induced nephropathy (Control group) should be compared with those who develop the damage (Case group)

    Time 0: before administration of the contrast media

Secondary Outcomes (7)

  • Contrast-induced nephropathy (CIN) development

    Time 0 (baseline, before contrast media) and daily for 5 days after contrast media

  • Percentage of patients with Risk factor's

    These data will be collected once, at time 0 (moment of inclusion in the study)

  • Body weight

    These data will be collected once, at time 0 (moment of inclusion in the study)

  • Height

    These data will be collected once, at time 0 (moment of inclusion in the study)

  • Age

    These data will be collected once, at time 0 (moment of inclusion in the study)

  • +2 more secondary outcomes

Study Arms (2)

Control (no CIN)

Patients who receive contrast media but do not develop contrast-induced nephropathy

Diagnostic Test: Early kidney damage biomarkersDiagnostic Test: Predisposition to kidney injury biomarkers

Case (yes CIN)

Patients who receive contrast media and develop contrast-induced nephropathy

Diagnostic Test: Early kidney damage biomarkersDiagnostic Test: Predisposition to kidney injury biomarkers

Interventions

Early kidney damage biomarkersDIAGNOSTIC_TEST

In the urine samples of these patients, a series of biomarkers of early kidney damage and / or predisposition to kidney damage will be measured

Also known as: N-acetyl-beta-D-glucosaminidase (NAG), Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL), Albumin
Case (yes CIN)Control (no CIN)
Predisposition to kidney injury biomarkersDIAGNOSTIC_TEST

In the urine samples of these patients, a series of biomarkers of predisposition to kidney damage will be measured

Case (yes CIN)Control (no CIN)

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will receive an iodinated contrast medium as part of a diagnostic or interventional procedure

You may not qualify if:

  • Patients who are terminally ill
  • Patients who do not wish to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Cardiología del CAUSA

Salamanca, 37009, Spain

Location

Related Publications (1)

  • Vicente-Vicente L, Casanova AG, Hernandez-Sanchez MT, Prieto M, Martinez-Salgado C, Lopez-Hernandez FJ, Cruz-Gonzalez I, Morales AI. Albuminuria Pre-Emptively Identifies Cardiac Patients at Risk of Contrast-Induced Nephropathy. J Clin Med. 2021 Oct 26;10(21):4942. doi: 10.3390/jcm10214942.

    PMID: 34768464RESULT

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ana Isabel Morales Martín, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)