Novel Biomarkers for Risk Prediction of Contrast-Induced... | NCT02263820

Studies
Novel Biomarkers for Risk Prediction of Contrast-Induced Acute Kidney Injury Post Coronary Angiography

NCT02263820

Sponsor

Sapere Bio

Status

Completed

Last Update Posted

Aug 17, 2018Actual

Enrollment

185Actual

Phase

Not provided

Conditions

Acute Kidney Injury
Renal Insufficiency
Kidney Diseases

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Oct 8, 2014

First Submission Date that Met QC Criteria

Oct 10, 2014

First Posted Date

Oct 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2018

Last Update Posted Date

Aug 17, 2018Actual

Name	Class
University of North Carolina, Chapel Hill	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Contrast-induced acute kidney injury (CI-AKI) has been recognized as the third most common cause of hospital acquired AKI, after hypotension-associated hypo-perfusion and post-operative AKI. The development of CI-AKI after cardiac catheterization is associated with a significant increase in both short-term and long-term mortality and morbidities, as well as an increase in length of stay and cost.

The only marker of renal function that has predictive ability is creatinine and it has significant limitations in identifying patients who will develop AKI. Therefore, a diagnostic test for predicting CI-AKI risk would have widespread clinical utility.

The primary purpose of this study is to measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CI-AKI post cardiac catheterization.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

185Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in serum creatinine levels (absolute and percentage)		Measured 48-72h after catheterization

Secondary Outcomes

Measure	Description	Time Frame
Major Adverse Clinical Events (MACE, a composite of all-cause mortality, myocardial infarction or renal replacement therapy)		Within 90 days after catheterization
Admission to the ICU		Within 90 days after catheterization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (>18 yo) undergoing invasive coronary angiography with or without percutaneous coronary intervention (PCI), that are predicted to have ≥14% risk of developing AKI as defined by Mehran et al.
Medically compliant and able to consent and follow detailed directions
Agree to additional collection of blood sample 48-72h post cardiac catheterization

Exclusion Criteria:

Presence of acute, active infection (e.g. HIV, pneumonia, septic shock).
Contrast media exposure within last 48h
Presenting with systolic time-segment elevation myocardial infarction.
Presence of cardiogenic shock
Presence of hemodynamic instability or requiring pressors or intra-aortic balloon pump
Severe kidney disease with estimated glomerular filtration rate <30 mL/min/1.73m2 or receiving dialysis for end stage renal disease
Kidney transplant and liver transplant patients and all patients currently on immunosuppressants
Severe heart failure with known ejection fraction <25%
Prior heart transplant
Chronic liver disease /cirrhosis
Patients actively undergoing chemotherapy or radiation treatment for any indication.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults undergoing cardiac catheterization with or without percutaneous coronary intervention (PCI)

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
George A Stouffer, MD	University of North Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UNC Center for Heart & Vascular Care		Chapel Hill	North Carolina	27599	United States

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D051437	Renal Insufficiency
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided