Periprocedural Myocardial Infarction: the Role of Human N... | NCT02591264

Studies
Periprocedural Myocardial Infarction: the Role of Human Neutrophil Peptide-1 to 3

NCT02591264

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Oct 29, 2015Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Coronary Thrombosis

Interventions

Blood sample

Countries

Israel

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 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Oct 28, 2015

First Submission Date that Met QC Criteria

Oct 28, 2015

First Posted Date

Oct 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 28, 2015

Last Update Posted Date

Oct 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 aim of this study is to determine the role of human neutrophil peptide-1 to 3 in the occurrence of periprocedural myocardial infarction.

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

120Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Other	Blood sample drawn from participants for analysis of neutrophil peptide level

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Human Neutrophil Peptide Level	Laboratory analysis and measurement of Human Neutrophil Peptide-1 to 3 levels	Two hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Troponin negative patients
Stable angina
Unstable angina
Positive screening tests

Exclusion Criteria:

Troponin positive
Technical failure of procedure
Hemodynamic unstability

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

Troponin negative patients assigned for stent implantation in our medical institution.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rami Abu Fanne, MD, PhD	Contact	972-50-3573694		ramia@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003328	Coronary Thrombosis

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided