Prokinecitine in Acute Myocardial Infarction | NCT02021487

Studies
Prokinecitine in Acute Myocardial Infarction

NCT02021487

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Aug 21, 2019Actual

Enrollment

172Actual

Phase

Not provided

Conditions

ST Elevatation Myocardial Infarction (STEMI)

Interventions

Not provided

Countries

France

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 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment difficulty

Expanded Access Info

Start Date

Nov 2013Actual

Primary Completion Date

Feb 2019Actual

Completion Date

Feb 2019Actual

First Submitted Date

Dec 19, 2013

First Submission Date that Met QC Criteria

Dec 19, 2013

First Posted Date

Dec 27, 2013Estimated

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 19, 2019

Last Update Posted Date

Aug 21, 2019Actual

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 study aims to investigate the presence of a substance in the blood called prokinecitine, which is released by the heart when a heart attack occurs. Several venous blood samples at the arm are withdrawn at admission, H6, H12, H24, H48 and H72 in order to measure the concentration of this substance in the blood. The usefulness of this new blood marker is going to be determsined to seek if it would be of help to better diagnose or estimate the gravity of heart infarction after a heart attack.

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

No data available

No data is available for this block.

Enrollment

172Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infarct size by MRI necrotic myocardial mass	Infarct size by MRI necrotic myocardial mass	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with acute St elevation myocardial infarction of less than 6 hours
Age>18 y/o

Exclusion Criteria:

Previous myocardial infarction
LBB, RBB
Renal Insuffiency MDRD<30 mL/min
Patient with Pace-Maker or ICD.

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

Patients with acute St elevation myocardial infarction of less than 6 hours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick OHLMANN, MD	University Hospital, Strasbourg, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Strasbourg		67000	France