Evaluation of hsTnI in the Management of Patients With Chest Pain in the Emergency Department

NCT02789904 | Completed

• 1 other identifier: 2014/2182
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Current standard of care algorithm using high sensitivity troponin T (hsTnT) requires up to 6.5 hours to diagnose an ACS. Data will be stratified based upon time of symptom onset and gender. A health economics and outcome model will be applied using the optimal high sensitivity troponin I (hsTnI) cut-off values and draw times to determine the cost and outcome benefits predicted from optimal utilization of hsTnI. A chest pain registry will be set up to compare high sensitivity troponin I (hsTnI) versus high sensitivity troponin T (hsTnT) for all patients who present to the emergency department and require a blood draw. The outcomes of these patients will be tracked over the study period. The purpose of conducting this study evaluation is:

1. 1.To shorten the chest pain protocol for suitable patients to \< 3 hours compared to the current 6 hours protocol with the latest high sensitivity Troponin I assays.
2. 2.To determine the validity of Abbott ARCHITECT i2000 and Beckman Coulter ACCESS AccuTnI+3 with an accelerated algorithm in comparison to the standard of care acute coronary syndrome (ACS) algorithm and high sensitivity troponin T (hsTnT) assay, to rule-out or rule-in for an ACS within 3 hours of presentation to the emergency room (ER) with isolated suspected ACS.
3. 3.To establish the local reference norms for hsTnI assays.

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

• First cardiovascular event

  1 year

Study Arms (1)

Chest pain patients in DEM

Recruitment done at SGH DEM. Blood taking will be done at 0, 1 and 2 hr.

Other: blood taking

Interventions

blood taking OTHER

Blood taking will be done for chest pain patients presenting with chest pain at 0, 1 and 2 hour

Chest pain patients in DEM

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with chest pain to SGH DEM

You may qualify if:

• Aged 21 years and above
• Ability to provide written, informed consent
• Presentation to ER with chief complaint of chest pain OR has symptoms suggestive of angina equivalent without chest pain
• ER physician determines patient has symptoms suggestive of ACS
• ER physician orders troponin test for clinical purposes

You may not qualify if:

• Diagnosed with STEMI
• Poor pre-morbid Eg. Bedridden
• Advanced malignancy/ terminal disease

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• Singapore General Hospital: collaborator
• Beckman Coulter GmbH: collaborator
• Abbott: collaborator

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Tan Wei Chieh Jack, MBBS

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 3, 2016
• Study Start: October 5, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 19, 2021

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)