Details of HTA project
Last updated: 31 August 2010 - Next update due: 7 September 2010
Research type: |
Primary Research (e.g. trial) |
Project title: |
The RATPAC Trial: Randomised Assessment of Treatment using Panel Assay of Cardiac markers |
Project ref: |
06/302/19 |
Cost: |
£791,642 |
Chief Investigator : |
Professor Steven Goodacre, Professor and Consultant in Emergency Medicine, School of Health and Related Research, University of Sheffield |
Start Date: |
April 2007 |
Estimated date of publication in HTA journal series: |
February 2011. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed. |
Plain English Summary |
Acute chest pain is one of the most common reasons for people to have to go to hospital as an emergency. When this is happens it is important that a heart attack is reliably ruled out before the patient is sent home. However, in many cases the currently available tests cannot reliably rule out a heart attack so the patient has to be admitted to hospital. If the chest pain turns out to be due to a non-serious cause, such as indigestion or pain from the muscles of the chest wall, then hospital admission will have been an unnecessary inconvenience for the patient and a waste of health service resources. New blood tests offer a possible solution to this problem. Previous research has shown that measuring three different tests at two times, 90 minutes apart, using a machine that can be used by a doctor or nurse at the patient's bedside (a "point of care" test) can rapidly and reliably rule out a heart attack in selected low-risk patients. This test therefore has the potential to provide a rapid diagnosis, allowing early treatment for people with a heart attack and avoidance of unnecessary hospital admission for those without. We plan to evaluate this test in six NHS hospitals by comparing a group of patients who are tested with the new, point of care blood test to a group of patients who receive standard, currently available tests. We will compare the rate of admission to hospital in each group to find out whether the new test reduces the need for hospital admission. We will also send questionnaires to all participants in the research to ask about their quality of life and satisfaction with care received, and review patient case notes and computer records to identify any serious events, such as subsequent heart attacks. All patients asked to take part in the research will be provided with written information about the research and asked to sign a consent form before they take part. The research team includes experts in emergency care, heart disease, and blood testing, along with statisticians and health economists from the University of Sheffield. We have previously successfully undertaken similar projects that have led to changes in the care of patients with acute chest pain. |
Project Abstract: |
We will evaluate the effectiveness of a point-of-care cardiac marker panel, comprising of CK-MB, myoglobin and troponin I. We will randomly allocate patients to receive either: a) Diagnostic assessment using the point-of-care biochemical marker panel, or b) Conventional diagnostic assessment without the 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 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. We will also store blood samples to test new and alternative markers to explore whether these might be more effective or cost-effective than the CK-MB, myoglobin, troponin I panel. Cost and outcome data will be collected using routine data sources and self-complete questionnaires mailed to participants at one and three months. The primary outcome will be the proportion of patients successfully discharged home after emergency department assessment, defined as discharge with no adverse event (as defined below) during the following three months. Secondary outcomes will include: 1) Health utility measured at one and three months after attendance; 2) Satisfaction with care; 3) The proportion of patients managed on the coronary care unit and receiving cardiac treatments, such as heparin, clopidogrel or glycoprotein inhibitors; 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). Health service costs will be measured for three months from initial attendance, including diagnostic tests, emergency department attendances and hospital admissions, outpatient reviews, and cardiac procedures. Cost analysis will compare bootstrap estimates of the mean cost per patient of the two groups. Cost-effectiveness analysis will estimate the incremental cost per quality-adjusted life year of using point-of-care cardiac marker testing compared to management without point-of-care testing. |
NRR* number, if applicable: |
N0484190632 (*National Research Register). The National Research Register was a public database of ongoing and recently completed research projects funded by, or of interest to, the United Kingdom's National Health Service (NHS). It is now an archive of projects from early 2000 to September 2007. Search the NRR archive. |
ISRCTN* number: | ISRCTN 37823923 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN37823923 |
Project Protocol: |
Project protocol (pdf format, 120 kbytes) |
URL of this page: |
http://www.hta.ac.uk/1602 |
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