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Establishing Clinical Utility of a New Diagnostic Test in Patients Undergoing Cardiac Catheterization

NCT04266834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2020-09-16

No results posted yet for this study

Summary

This study will collect high-quality randomized controlled data across the U.S. from practicing cardiologists performing invasive/interventional procedures and determine how they currently manage patients at risk for CIN and how the results of Hikari's L-FABP test change clinical decision making.

Conditions

  • AKI
  • Contrast-induced Nephropathy

Interventions

OTHER

Experimental Arm

First, these providers will receive educational materials (e.g. a slide deck and one-page fact sheet) meant to mimic what physicians will receive in the real-world market as they learn about the Hikari DX L-FABP test. Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the L-FABP test at the clinically-appropriate point in each case.

Sponsors & Collaborators

  • Hikari DX

    collaborator UNKNOWN

  • Qure Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • John Peabody, MD, PhD · President, QURE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2020-06-01
Completion
2020-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT04266834 on ClinicalTrials.gov