Use of Urinary Cell-Cycle Arrest Biomarkers in Contrast-Associated Nephropathy After Coronary Angiography

NCT04163250 | Completed

• 1 other identifier: GV/2019/003
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

Radiological examinations that require the administration of iodinated contrasts (IC) for diagnostic and therapeutic purposes are essential in current clinical practice, and their use in interventional procedures has been progressively increasing. IC can cause kidney damage, so there is caution in their use in at-risk populations. This fact may limit its diagnostic use, with data on underutilization of interventional techniques in patients with renal insufficiency, which worsen their prognosis. In addition, once the use of IC contrasts is decided, preventive measures, such as hyperhydration,are used and can have potential side effects, especially in patients at risk of heart failure (acute coronary syndrome, low left ventricular ejection fraction). New biomarkers of kidney damage have recently been developed, based on the detection of molecules expressed by the kidney in situations of early damage. The quantitative determination of cell cycle arrest proteins (Tissue Inhibitor of metalloproteinase 2 (TIMP2) and Insulin-Like Growth Factor Binding Protein -7 (IGFBP7)) can be predictive of the development of moderate to severe contrast-associated acute kidney injury. Urinary determination of \[TIMP-2\] x \[IGFBP7\] in patients with ACS (acute coronary syndromes) before cardiac catheterization would allow early identification of those patients vulnerable to IC-induced toxicity and adjustment of preventive measures.

Conditions

Contrast-induced Nephropathy

Keywords

Contrast media; Urinary cell-cycle arrest biomarkers; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Contrast-Associated Acute Kidney Injury

  Absolute increase of 0.3 mg / dl in the creatinine value and / or a relative increase greater than 1.5 times the baseline creatinine value, measured at 48 and 72 hours after exposure to contrast.

  up to 72 hours of exposure

Secondary Outcomes (2)

• Mortality

  up to 30 days

• Need of renal replacement techniques

  From exposure to contrasts to three months

Study Arms (1)

Patients with ACS undergoing cardiac catheterization

Adults with moderate / high risk acute coronary syndrome undergoing coronary intervention. The sample will be selected consecutively, including patients admitted to the Cardiac Coronary Unit and who require a radiological test with intra-arterial IC administration, for diagnostic or diagnostic / therapeutic purposes

Diagnostic Test: Urinary determination of TIMP-2/ IGFBP7

Interventions

Urinary determination of TIMP-2/ IGFBP7 DIAGNOSTIC_TEST

Urinary determination of TIMP2-IGFBP7 in the an urine sample obtained within 12 hours prior to contrast administration. A single determination will be made, which will be sent to the laboratory. The doctor who treats the patient will not know the result of the test, and the treatment will not be influenced by the result. According to the manufacturer, 10 ml of fresh urine should be collected in a sterile container and the laboratory should centrifuge them within the time of collection. The result is reported as a single value calculated as the concentration of TIMP-2 (ng / mL) multiplied by the concentration of IGFBP7 (ng / mL) divided by 1000. The result is reported without units.

Patients with ACS undergoing cardiac catheterization

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 21 years, with moderate / high risk acute coronary syndrome according to GRACE score and exposed to intra-arterial iodinated contrast media

You may qualify if:

• Patients older than 21 years exposed to intra-arterial iodinated contrast media for diagnostic / therapeutic purposes and who have signed the Informed Consent document.

You may not qualify if:

• Patients who have been exposed to a previous dose of iodinated contrast within 72 hours prior to recruitment.
• Patients with urgent radiodiagnostic intervention criteria, when it is not possible to obtain a previous urine sample without delaying the diagnosis and / or the intervention.
• Patients in anuria.
• Patients with chronic kidney disease, treated with hemodialysis (HD) or peritoneal dialysis.
• Bilirubinuria: bilirubin concentrations in the urine\> 7.2 g / dL interfere with the result.
• Patients in terminal situations, in which diagnostic and therapeutic tests are limited.
• Patients under 21 years.

Sponsors & Collaborators

• Eva de Miguel Balsa: lead

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 14, 2019
• Study Start: June 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

ES (1)