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Modified HEART as Rule Out for Suspected ACS

Does Modified Heart Score Incorporating Undetectable and 99th Percentile High Sensitivity Troponin T Limits Improve Early, Safe Discharge for Suspected Acute Coronary Syndromes

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03619733
Enrollment
1100
Registered
2018-08-08
Start date
2018-06-01
Completion date
2018-12-01
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain

Keywords

HEART score, troponins

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

Detailed description

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). the investigators 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. The second centre (Royal Liverpool University Hospital) was external to where the initial cohort of 1642 patients were assessed that defined modified HEART as the optimal score. The modified HEART score is as follows: HEART score can be re-calibrated (modified HEART) to undetectable hstnT and 99th percentile limits (\<5= 0, ≥5-14=1, \>14=2). Troponin (HSTnT) Roche (elecsys) \>14ng/l 2 5-14ng/l 1 \<5ng/l 0 This 2 centre study will enrol consecutive patients with suspected acute coronary syndrome (defined as physician suspicion of ischaemic chest pain resulting in sampling of High sensitive troponin and undertaking an electrocardiogram at presentation). For all troponin positive patients (HSTnT\>14ng/l) the diagnosis will be adjudicated centrally with at least 2 'blinded' clinicians. The outcome will be MACE at 6 weeks. MACE will be defined by acute myocardial infarction, urgent or emergency coronary revascularisation and all cause death. Power calculations (provided by clinical trials, university of Liverpool): Assuming: Prevalence of MACE events in the population with suspected ACS is 12.5% (as in MACROS) The anticipated sensitivity is 0.98 The acceptable value for the 95% confidence interval for sensitivity is 0.95 The power of the study is 80% Then the number of events needed would be approximately 150. Thus 150/0.125 = 1200 suspected ACS admission would need to be enrolled The study has been assessed by research boards at both hospitals and has been registered as an audit, with the primary aim of quality control of a novel accelerated chest pain pathway that has been recently implemented at both hospitals. The study does not require individualised patient consent and is supported by the Caldicott Guardian. Secondary aims of the study are to compare the performance of modified HEART score with modified TIMI \< or equal to 1 or 0 and modified GRACE score \< or equal to 75 in terms of rule out for MACE at 6 weeks The investigators compare the 'performance' of modified HEART with the use of undetectable HSTnT \<5ng/l (combined with a nonischaemic ECG). The latter is part of the recently adopted chest pain pathway at both recruiting hospitals with clear guidance of discharge at presentation for patients with chest pain who have an undetectable HSTnT and nonischaemic ECG. Therefore it will allow the research team to compare modified HEART virtual discharge with actual (rather than virtual) discharge for an approach based on undetectable HSTnT.

Interventions

OTHERno intervention

this is an observational study. no intervention is planned

Sponsors

Royal Liverpool University Hospital
CollaboratorOTHER_GOV
University of Liverpool
CollaboratorOTHER
Liverpool University Hospitals NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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 \-

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of Major adverse cardiac event for patients with HEART score<=36 weeksadjudicated myocardial infarction, urgent or emergency coronary revascularisation, all-cause Death

Secondary

MeasureTime frameDescription
incidence of acute myocardial infarction for patients with HEART <=36 weeksadjudicated centrally by 2 physicans blinded to heart scores and to colleagues score

Countries

United Kingdom

Contacts

Primary Contactaleem khand
akhand31@aol.com00441516002720

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026