Modified HEART as Rule Out for Suspected ACS

NCT03619733 | Unknown

• 1 other identifier: AintreeNHS
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 2

Brief Summary

Validation of modified HEART score as a rule-out criterion for MACE at 6 weeks: a 2 centre prospective observational cohort with a direct comparison to TIMI, GRACE and high sensitive troponin T at limits of detection Detailed description: The HEART score, as defined previously by Backus et al1, is a risk score specifically developed for acute chest pain/ suspected acute coronary syndrome. The conventional scoring system for the troponin component of HEART is as follows: Troponin \<99th percentile =0 (in the case of Hstn T \[Roche} 14ng/l, 99th percentile up to X3 URL (99th percentile)= 1 (HSTN T =14-42ng/L, \>x3 URN =2 (HSTN T \>42ng/l). We have previously defined that the optimal rule-out strategy for suspected acute coronary syndromes may well be a modified HEART score in a single centre study. This study is to prospectively validate the use of this score in a prospective unselected cohort of patients with possible acute coronary syndrome at 2 large secondary care centres

Conditions

Chest Pain

Keywords

HEART score, troponins

Outcome Measures

Primary Outcomes (1)

• incidence of Major adverse cardiac event for patients with HEART score<=3

  adjudicated myocardial infarction, urgent or emergency coronary revascularisation, all-cause Death

  6 weeks

Secondary Outcomes (1)

• incidence of acute myocardial infarction for patients with HEART <=3

  6 weeks

Interventions

no intervention OTHER

this is an observational study. no intervention is planned

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive presentations to A\&E at 2 major urban hospital swith chest pain that the clinicans feel warrants a biomarker check for myocyte necrosis (high sensitive troponin) and presentation ECG

You may not qualify if:

• primary presentation not chest pain
• clear noncardiac cause of chest pain such as trauma life expectancy \<1 year due to noncardiac pathology

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• Royal Liverpool University Hospital: collaborator
• University of Liverpool: collaborator

Study Sites (2)

University Hospital Aintree

Liverpool, L97AL, United Kingdom

RECRUITING

Royal Liverpool university hospital

Liverpool, United Kingdom

RECRUITING

Related Publications (1)

• Khand AU, Backus B, Campbell M, Frost F, Mullen L, Fisher M, Theodoropoulos KC, Obeidat M, Batouskaya K, Carlton EW, Van Meerten K, Neoh K, Dakshi A, Mumma BE. HEART Score Recalibration Using Higher Sensitivity Troponin T. Ann Emerg Med. 2023 Oct;82(4):449-462. doi: 10.1016/j.annemergmed.2023.04.024. Epub 2023 Jun 10.

  PMID: 37306637 DERIVED

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

aleem khand

CONTACT

00441516002720; akhand31@aol.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 123 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: cosultant interventional cardiologist

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: August 8, 2018
• Study Start: June 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)