Plasma Biomarkers in Cardiac Valve Surgery | NCT02641665

Studies
Plasma Biomarkers in Cardiac Valve Surgery

NCT02641665

Sponsor

University of Liege

Status

Unknown status

Last Update Posted

Oct 6, 2017Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Elective Valvular Cardiac Surgery

Interventions

Cardiac valve surgery

Countries

Belgium

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Dec 22, 2015

First Submission Date that Met QC Criteria

Dec 22, 2015

First Posted Date

Dec 29, 2015Estimated

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

Oct 5, 2017

Last Update Posted Date

Oct 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean François Brichant, Professor, Head of Department, University of LiegePrincipal Investigator

Lead Sponsor

University of LiegeOTHER

Collaborators

Not provided

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

The level of four biomarkers will be measured in the patients' plasma after induction of anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these marker will then be correlated with early (30 days) and late (one year) patients' prognosis and with functional recovery (MLHFQ score).

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

250Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac valve surgery	Procedure	Aortic or mitral valve replacement/repair performed in isolation of in addition to coronary artery bypass graft(s).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite primary outcome	In hospital or 30-days mortality or inotropic support during more than 48 hours or lengthy of ICU stay longer than 5 days	30 days

Secondary Outcomes

Measure	Description	Time Frame
ICU readmission		30 days
Post-operative AKI	AKIN stage during the first 48 hours	48 hours
Ejection fraction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Elective/urgent aortic or mitral valve surgery in isolation or combined with CABG

Exclusion Criteria:

Emergency or salvage surgery
Inability to consent
Previous cardiac surgery
Stage IV or V CDK (GFR ≤ 30 ml/min) or dialysis
Active Endocarditis
Liver cirrhosis
Chronic atrial fibrillation
Pacemaker

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

Adult patients undergoing elective or urgent cardiac valve surgery in isolation of in combination with CABG.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gregory A Hans, MD, PhD	Contact	+3243667655		G.Hans@chu.ulg.ac.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU of Liege	Recruiting	Liège		4000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided