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A randomised controlled trial of point-of-care cardiac markers in the emergency department

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37823923
Enrollment
3130
Registered
2007-02-01
Start date
2007-04-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Chest pain due to suspected but not proven AMI Circulatory System Acute Myocardial Infarction

Interventions

This is a pragmatic randomised controlled trial and economic evaluation of a point-of-care cardiac marker panel in the management of patients with suspected, but not proven, Acute Myocardial Infarctio

Sponsors

University of Sheffield (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: People presenting to the Emergency Department with chest pain due to suspected but not proven Acute Myocardial Infarction (AMI) in whom a negative point-of-care marker test could potentially rule out AMI and allow discharge home.

Exclusion criteria

Exclusion criteria: 1. Patients with diagnostic Electrocardiogram (ECG) changes for AMI or high-risk acute coronary syndrome (more than 1 mm ST deviation or more than 3 mm inverted T waves). These patients are at high risk of adverse outcome and require inpatient care even if marker tests are negative 2. Patients with known coronary heart disease presenting with prolonged (more than one hour) or recurrent episodes of typical cardiac-type pain. These patients have unstable angina and require inpatient care for symptom control even if marker tests are negative 3. Patients with proven or suspected serious non-coronary pathology (e.g. pulmonary embolus) that requires inpatient care even if AMI is ruled out 4. Patients with co-morbidity or social problems that require hospital admission even if AMI can be ruled out 5. Patients with an obvious non-cardiac cause (e.g. pneumothorax or muscular pain), in whom AMI can be excluded as a possible cause without resorting to further diagnostic testing 6. Patients presenting more than 12 hours after their most significant episode of pain, for whom a single troponin measurement would clearly be more appropriate than point-of-care panel testing 7. Previous participants in the RATPAC trial 8. Patients who are unable to understand the trial information due to cognitive impairment 9. Non-English speaking patients for whom translation facilities are not available

Design outcomes

Primary

MeasureTime frame
Proportion of patients successfully discharged home after Emergency Department assessment, defined as discharge with no adverse event (defined in next section) during the following three months.

Secondary

MeasureTime frame
1. Health utility measured using the Euro Quality of life (EQ-5D) self-complete questionnaire at one and three months after attendance 2. Satisfaction with care measured at one month after attendance using a modified Group Health Association of America questionnaire that has been used successfully in previous studies of diagnostic strategies for acute chest pain 3. The proportion of patients managed on the coronary care unit, receiving cardiac medications (such as heparin, clopidogrel or glycoprotein IIb/IIIa inhibitors) or receiving cardiac interventions (such as angiography, percutaneous intervention or bypass grafting) 4. Re-attendance at and/or re-admission to hospital over the following three months 5. Adverse events (death, non-fatal AMI, emergency revascularisation or hospitalisation for myocardial ischaemia) 6. The proportion of admitted patients ultimately diagnosed as having AMI by European Society of Cardiology (ESC)/American College of Cardiology (ACC) criteria

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026