NCT01612117

Brief Summary

Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration. This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
244

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 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

November 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

3 months

First QC Date

May 30, 2012

Last Update Submit

May 27, 2014

Conditions

Keywords

renal failurecardiologycontrast-induced nephropathy

Outcome Measures

Primary Outcomes (1)

  • to assess the value of uNGAL measurement 4 to 6 hours after PCP as a possible early detector of CIN

    cf title

    4-6 hours after PCP

Secondary Outcomes (1)

  • to study the relationship between the volume of contrast medium used for PCP and the uNGAL levels measured 4 to 6 hours thereafter

    4-6 hours after PCP

Study Arms (1)

consecutive, PCP patients

All patients requiring percutaneous coronary procedures, such as coronary angiography or intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all consecutive patients

You may not qualify if:

  • dialysis-dependent chronic kidney disease
  • lack of written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology

Fribourg, Canton of Fribourg, 1708, Switzerland

Location

Related Publications (1)

  • Perrin T, Descombes E, Magnin JL, Gachet M, Hemett OM, Hayoz D, Stolt V, Baeriswyl G, Stauffer JC, Goy JJ, Togni M, Cook S. Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) and contrast-induced acute kidney injury after coronary angiogram. Swiss Med Wkly. 2013 Aug 27;143:w13853. doi: 10.4414/smw.2013.13853. eCollection 2013.

Biospecimen

Retention: SAMPLES WITHOUT DNA

urinary samples

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Stephane Cook, MD

    University Fribourg

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 5, 2012

Study Start

November 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations