NCT02897492

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2.5 years

First QC Date

August 29, 2016

Last Update Submit

March 27, 2019

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

  • Time to detect troponin elevation

    sixty to 120 minutes

Interventions

Blood testing in a newly described methodOTHER

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.

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chest Pain

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Shadi Hamoud

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 13, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 20, 2019

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share