Rapid and Highly Sensitive Detection of Fluorescently-lab... | NCT02897492

Studies
Rapid and Highly Sensitive Detection of Fluorescently-labeled Troponin in Patients Admitted With Chest Pain

NCT02897492

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Mar 28, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Chest Pain

Interventions

Blood testing in a newly described method

Countries

Not provided

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

Mar 2019

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

Sep 1, 2016Actual

Primary Completion Date

Mar 1, 2019Actual

Completion Date

Mar 20, 2019Actual

First Submitted Date

Aug 29, 2016

First Submission Date that Met QC Criteria

Sep 12, 2016

First Posted Date

Sep 13, 2016Estimated

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

Mar 27, 2019

Last Update Posted Date

Mar 28, 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

Patients with chest pain may have postponed or missed diagnosis of acute coronary events due to relatively late detection of troponin elevation. The study will investigate a new diagnostic method for early detection of even minimal troponin elevation in patients admitted with chest pain.

Detailed Description

A new diagnostic method will be applicated in the recent studies.

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

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood testing in a newly described method	Other	To exploit detection strategy termed "Magnetic Modulation Biosensing", or MMB) to develop a novel, low-cost platform that can detect biomarkers, such as proteins and specific DNA sequences, rapidly and directly from real samples at very low concentrations.

Measure	Description	Time Frame
Time to detect troponin elevation		sixty to 120 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years old or older
Admitted to Rambam health campus for the investigation of chest pain

Exclusion Criteria:

1. No exclusion criteria will be applied

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Enrolled subjects will be patients admitted to Rambam health campus for the investigation of chest pain. Five m"l blood will be collected for troponin assay. No further intervention will be applied for subjects. Blood will be centrifuged and plasma separated for study purposes (detailed in "methods"- section 3.2.1.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002637	Chest Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided