Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Steve Goodacre
ORCID ID
Contact details
Medical Care Research Unit
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 0750
s.goodacre@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 06/302/19
Study information
Scientific title
Acronym
RATPAC (Randomised Assessment of Treatment using Panel Assay of Cardiac markers)
Study hypothesis
To evaluate the clinical effectiveness and cost-effectiveness of the most promising point-of-care cardiac marker panel currently used in the Emergency Department.
Please note that, as of 11/05/2009, the anticipated end date of this trial has been updated from 31/03/2009 to 30/09/2009.
Ethics approval
Ethics approval received from the Leeds East Research Ethics Committee on the 27th March 2007 (ref: 07/Q1206/22).
Study design
A pragmatic randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information sheet can be found at: http://www.shef.ac.uk/content/1/c6/06/76/17/Patient%20information%20sheet.pdf
Condition
Chest pain due to suspected but not proven AMI
Intervention
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 Infarction (AMI) in six Emergency Departments in the United Kingdom. Emergency Department staff will identify eligible patients, provide trial information and obtain written consent.
Participants will be randomised to receive either:
1. Diagnostic assessment using the point-of-care biochemical marker panel, or
2. Conventional diagnostic assessment without the panel.
The only difference between the two arms of the trial will be that patients in the intervention arm will receive testing with the point-of-care panel. The use of all other tests and treatments, and decision-making in the Emergency Department, will be at the discretion of the attending clinician.
The point-of-care cardiac marker panel will comprise Creatine Kinase - Myocardial Bands (CK-MB) (mass), myoglobin and troponin I, measured at presentation and 90 minutes later, using the Biosite Triage cardiac marker panel. This combination has been widely evaluated in practice. An independent evaluation by the Centre for Evidence-based Purchasing found that the Biosite system was reliable and easy to use, and that the ability of the point-of-care method to detect a positive troponin was similar to that of laboratory methods.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
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
Overall trial start date
01/04/2007
Overall trial end date
30/09/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
3130
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medical Care Research Unit
Sheffield
S1 4DA
United Kingdom
Sponsor information
Organisation
University of Sheffield (UK)
Sponsor details
Research Services Department
New Spring House
231 Glossop Road
Sheffield
S10 2GW
United Kingdom
+44 (0)114 222 1448
R.J.Hudson@sheffield.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/20884788
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21616014
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23597479
Publication citations
-
Results
Goodacre SW, Bradburn M, Cross E, Collinson P, Gray A, Hall AS, , The Randomised Assessment of Treatment using Panel Assay of Cardiac Markers (RATPAC) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department., Heart, 2011, 97, 3, 190-196, doi: 10.1136/hrt.2010.203166.
-
Results
Goodacre S, Bradburn M, Fitzgerald P, Cross E, Collinson P, Gray A, Hall AS, The RATPAC (Randomised Assessment of Treatment using Panel Assay of Cardiac markers) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department., Health Technol Assess, 2011, 15, 23, iii-xi, 1-102, doi: 10.3310/hta15230.
-
Results
Collinson PO, Gaze DC, Thokala P, Goodacre S, Randomised Assessment of Treatment using Panel Assay of Cardiac markers--Contemporary Biomarker Evaluation (RATPAC CBE)., Health Technol Assess, 2013, 17, 15, v-vi, 1-122, doi: 10.3310/hta17150.