Biomarkers and Risk Scores for Risk Stratification of Unstable Angina

NCT03628586 | Unknown

• 1 other identifier: AintreeNHS1
• Study Type: observational
• Target: 489
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of the study is to improve management and expedite safe discharge of patients presenting with chest pain with troponin ≤14ng/l using fifth generation, 'highly sensitive' troponin T. Our aim would be to specifically test in a prospective study whether biomarkers for left ventricular wall stress (NT pro brain natriuretic peptide), ischaemia (Heart-type fatty acid protein) and a novel marker of stress, raised in a number of pathological states growth differentiation factor -15, add significantly to the prognostic value of clinical information and resting ECG presenting with ischaemic sounding chest pain. The 5th generation troponin assay will be used and the range of values from 1-14ng/l will also be compared to the biomarkers studied in terms of hard cardiac endpoints. Recent studies have indicated that very low levels of detected troponin in patients with stable coronary artery disease do adversely impact on cardiac death and the development of heart failure.

Conditions

Chest Pain

Keywords

acute coronary syndrome; biomarkers, HS troponins

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Event: death, myocardial infarction, revascularisation

  All cause death, myocardial infarction and revascularisation within 3 years of index presentation

  3 years

Eligibility Criteria

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

Study Population

1. Admission with chest pain which could be due to underlying ischaemic heart disease 2. HSTroponin T \< 15ng/L in patients with possible ischaemic sounding chest pain admitted to hospital at least 6 hours since onset of chest pain or in those with pain \<3hours since admission with no STEMI, a baseline HStroponin T \<15ng/l (time 0 on admission) and HSTroponin T \<15ng/l at 3 hours and \<20% increase compared to baseline (time 0) 3. Ability to give informed consent for extraction of blood for biochemical screening

You may qualify if:

• Patients presenting within 12 hours of chest pain thought to be cardiac in origin but with no ST segment elevation on ECG
• th generation troponin T \<15ng/l

You may not qualify if:

• Troponin positive patients, Tn T\>=15ng/lµg/l
• Diagnosis of non-cardiac chest pain made at outset
• Known History of chronic heart failure or cardiomyopathy

Sponsors & Collaborators

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

Related Publications (1)

• Jones J, Hughes E, Dobson R, Ashrafi R, Heseltine T, Campbell M, Collinson P, Khand A. Risk Stratification of Acute Chest Pain in Patients With High-Sensitivity Troponin T Below the 99th Percentile: A Long-Term Cohort Study Assessing the Incremental Value of Necrosis and Non-necrosis Biomarkers to Clinical Risk Scores. J Am Heart Assoc. 2025 Oct 21;14(20):e040590. doi: 10.1161/JAHA.124.040590. Epub 2025 Oct 14.

  PMID: 41085181 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples to allow extraction for a range of biologically plausible biomarkers associated with elevated risk in suspected acute coronary syndromes

MeSH Terms

Conditions

Chest Pain; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant interventional cardiologist

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: January 10, 2011
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08