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

NCT04163250 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 194

Last updated 2021-08-17

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Urinary determination of TIMP-2/ IGFBP7

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.

Sponsors & Collaborators

  • Eva de Miguel Balsa

    lead OTHER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-03-30
Completion
2021-03-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163250 on ClinicalTrials.gov