5th Generation cTnT in ED ACS

NCT03590535 | Completed

• 1 other identifier: AAAR7939
• Study Type: observational
• Target: 1,949
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to investigate the usefulness of the new "5th generation" cardiac troponin enzyme in determining which patients presenting with possible acute coronary syndrome can be quickly and safely discharged or admitted from the Emergency Department. The investigators hypothesize that introducing this enzyme into practice will reduce the time it takes to make decisions about admitting or discharging these patients with no increase in adverse events in the discharged patients.

Conditions

Acute Coronary Syndrome

Keywords

Emergency Department (ED)

Outcome Measures

Primary Outcomes (1)

• ED Provider to Decision Time (ED PTDT)

  Time in minutes from initial provider contact in the Emergency Department to disposition (admission versus discharge) decision.

  Duration of index Emergency Department Visit

Secondary Outcomes (1)

• Major Adverse Cardiac Events

  30 Days and 60 Days after initial Emergency Department Visit

Study Arms (1)

Patients with Possible ACS

Adult patients presenting to the Emergency Department with symptoms that maybe be caused by acute coronary syndrome, who are clinically considered to be at enough risk for ACS to send a cardiac enzyme as part of the diagnostic evaluation.

Diagnostic Test: 4th Gen cTnT; Diagnostic Test: 5th Gen cTnT

Interventions

4th Gen cTnT DIAGNOSTIC_TEST

Current "Fourth" Generation Cardiac Troponin T Enzyme Assay

Also known as: cTnT, cardiac troponin-T

Patients with Possible ACS

5th Gen cTnT DIAGNOSTIC_TEST

New "Fifth" Generation ("High-sensitivity") Troponin T Enzyme Assay

Also known as: hs-cTnT, high-sensitivity cardiac troponin-T

Patients with Possible ACS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients presenting to a single high volume, urban, tertiary care Emergency Department that sees greater than 94,000 patient visits a year in a predominantly Hispanic population.

You may qualify if:

• \- All patients presenting to the Adult Emergency Department (age 20 and above) for whom a troponin enzyme test is collected for the purpose of evaluating for possible acute coronary syndrome.

You may not qualify if:

• Not fluent in English or Spanish
• Inability to participate in follow-up (incarceration, lack of telephone access, cognitive impairment, etc.)
• Patients in or immediately post cardiac arrest
• Prior heart transplant

Sponsors & Collaborators

• Columbia University: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward H. Suh, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2018
• First Posted: July 18, 2018
• Study Start: September 24, 2018
• Primary Completion: June 7, 2020
• Study Completion: June 7, 2020
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)