Pragmatic Randomised Trial of the ESC 0/1 Versus 0/3 Hour Troponin Pathway

NCT05322395 | Recruiting DMC

• 1 other identifier: SPO635
• Study Type: interventional
• Target: 3,536
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the feasibility and impact of implementing the ESC 0-1 hour high sensitive troponin pathway in clinical practice and with specific reference to the 0-3 hour pathway currently in use. The principal outcome measure will be the safety of the 0-1 hour protocol (which is less established and has limited data on safety when implemented in clinical practice)

Conditions

Acute Coronary Syndrome; Troponin; Chest Pain; Point-of-care Systems

Keywords

acs; POC troponin; high sensitivity troponin

Outcome Measures

Primary Outcomes (2)

• percentage safe discharge by 4 hours. safety defined as type 1 MI and CV deah

  We will compare safe discharge by each strategy (ie the ESC 0-1 hour pathway versus 0-3 pathway) and the proportion actually discharged by each pathway at 4 hours. The exact definition of safety will be percentage (of cohort randomised to each pathway) safely discharged by 4 hours of presentation to accident and emergency (Safety will be judged by type 1 myocardial infarction, cardiovascular death by 4 weeks with sensitivity \>98% - the study will be powered on safety to establish whether 0-1-hour performance is equivalent to 0-3-hour sampling by means of a non-inferiority analysis- see statistics). (Type 1 myocardial infarction is due to acute coronary atherothrombotic myocardial injury with either plaque rupture or erosion and, often, associated thrombosis. A separate analysis will also be undertaken with inclusion of type 2 MI as well as type 1 MI as an endpoint

  4 hours

• point of care troponin performance compared to laboratory performance

  largely rule-out of Quidel triage true and siemens VTLI

  4 hours

Secondary Outcomes (9)

• Type 1 myocardial infarction

  30 days

• All cause death, type 1 myocardial infarction and urgent or emergency revascularisation. This analysis will be repeated incorporating both type 1 and 2 MI definition. (prespecified secondary analysis)

  30 days

• Proportion with rule-out or rule-in MI in the 0-1 hour and 0-3 hour

  30 days

• Prediction of MI with myocardial ischemic injury index (MI3) algorithm

  30 days

• HEART ≤3 and a modified HEART score for rule-out MI at 30 days

  30 days

Study Arms (2)

ESC 0/1 pathway

EXPERIMENTAL

A two-arm parallel group, two-centre pragmatic randomised controlled trial of 0-1-hour high sensitivity troponin T (hs cTnT) compared to a 0-3-hour pathway as rules for rapid discharge of suspected ACS. (both incorporating single presentation sample limit of detection (LOD) high sensitive troponin as a rule for discharge, or cut-off selected by manufacturer). The power of the study is on safety rather than percent discharge achieved by 4 hours as this is the primary focus for clinicians and health care institutions. (By virtue of the earlier sampling the 0-1 hour troponin sampling is likely to allow greater discharges by 4 hours and the sample size for safety easily accommodates this aspect).

Diagnostic Test: ESC 0/1 hour troponin pathway

ESC 0/3 hour pathway

ACTIVE COMPARATOR

A two-arm parallel group, two-centre pragmatic randomised controlled trial of 0-1-hour high sensitivity troponin T (hs cTnT) compared to a 0-3-hour pathway as rules for rapid discharge of suspected ACS. (both incorporating single presentation sample limit of detection (LOD) high sensitive troponin as a rule for discharge, or cut-off selected by manufacturer). The power of the study is on safety rather than percent discharge achieved by 4 hours as this is the primary focus for clinicians and health care institutions. (By virtue of the earlier sampling the 0-1 hour troponin sampling is likely to allow greater discharges by 4 hours and the sample size for safety easily accommodates this aspect).

Diagnostic Test: ESC 0/1 hour troponin pathway

Interventions

ESC 0/1 hour troponin pathway DIAGNOSTIC_TEST

randomisation to 0/1 versus 0/3 hour pathway

Also known as: esc 0/3 hour troponin pathway

ESC 0/1 pathway; ESC 0/3 hour pathway

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chest pain with moderate or high suspicion chest pain (see chest pain evaluation chart at end) or any patient the clinician deems suspicious for myocardial ischaemia thus requesting a troponin sample (between daytime hours 0800hrs to 1800hrs)
• Presentation \<12 hours since onset of chest pain (or unknown duration)
• Age \>18 years of age

You may not qualify if:

• ST elevation myocardial infarction (STEMI) infarct on the presenting electrocardiogram (ECG)
• Symptoms considered definitely non-cardiac
• Trauma
• Pregnancy
• Comorbid conditions requiring hospital admission
• Coronary artery bypass graft surgery (CABG) \<1 month
• coexistent clinical conditions likely to preclude follow-up.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• northwest coast academic science network: collaborator
• Quidel Corporation: collaborator
• Siemens Corporation, Corporate Technology: collaborator
• Abbott Diagnostics Division: collaborator

Study Sites (1)

liverpool university Hospital nhs foundation trust

Liverpool, GB, L186JR, United Kingdom

RECRUITING

Related Publications (1)

• Khand A, Hatherley J, Dakshi A, Miller G, Bailey L, Fisher M, Goulden C, Noori Z, Rawat A, Hornby R, Fearon H, Meah N, Davies S, Sekulska K, Hassan A, Lambert A, Phillips S, Raj R, Wiles T, Collinson P. Safety and feasibility of triage and rapid discharge of patients with chest pain from emergency room: A pragmatic, randomized noninferiority control trial of the European Society of Cardiology (ESC) 0 to 1 hour pathway vs conventional 0 to 3 hour accelerated diagnostic protocol. Am Heart J. 2024 Dec;278:235-247. doi: 10.1016/j.ahj.2024.08.005. Epub 2024 Aug 14.

  PMID: 39151715 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Heather Rodgers

  Liverpool University Hospitals NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Aleem Khand

CONTACT

+441515292720; aleem.khand@liverpoolft.nhs.uk

Ahmed Dakshi

CONTACT

+441515294738; ahmed.dakshi@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A two-arm parallel group, two-centre randomised controlled trial of 0-1-hour high sensitivity troponin T (hs cTnT) compared to a 0-3-hour pathway as rules for rapid discharge of suspected ACS. (both incorporating single presentation sample limit of detection (LOD) high sensitive troponin as a rule for discharge, or cut-off selected by manufacturer). The power of the study is on safety rather than percent discharge achieved by 4 hours as this is the primary focus for clinicians and health care institutions. (By virtue of the earlier sampling the 0-1 hour troponin sampling is likely to allow greater discharges by 4 hours and the sample size for safety easily accommodates this aspect).

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: April 11, 2022
• Study Start: December 10, 2021
• Primary Completion: June 1, 2024
• Study Completion: November 10, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

GB (1)