The information provided below is intended as a brief summary of the PUMA study. More technical and complete information is provided for the use of scientists and professionals here.

Information is provided below on the following topics:

Background

Aims of the PUMA study

The PUMA study design

Patient confidentiality

Approaching the partners of patients entered into PUMA.

Remember, if you do have any further queries you can contact us or provide feedback on the web-site.

In western countries, coronary heart disease (CHD) remains the leading cause of death and morbidity. Currently 2.65 million people in the UK suffer from this condition and every year over 20,000 people develop angina for the first time. In 2001, 275,000 people suffered a heart attack and CHD was responsible for over 120,000 deaths. Total CHD expenditure by the NHS in 1999 was £1,750 million.

Angiography is the “gold-standard” for diagnosing coronary heart disease. This involves injecting an x-ray dye into the coronary arteries (vessels which supply the heart with blood) to show any atherosclerosis (narrowings or blockages) within the coronary arteries. The procedure utilises a considerable amount of staff resources as each patient must be admitted to hospital for a day and is cared for by a wide range of medical professionals, both on the ward and in the catheterisation lab. Of all coronary angiograms performed to help diagnose coronary heart disease, approximately one quarter to one third show that the coronary arteries are normal. If a rapid, accurate test were available to screen patients with suspected heart disease, those found to have normal coronary arteries would be spared the worry and risk of undergoing angiography.

Such a test is currently under development and it involves a new laboratory technique known as “multiplex assays”. Multiplex assays involve the measurement of many different molecules within the blood or urine at the same time (up to thousands at a time). Results from early studies indicate that such tests are very accurate at diagnosing heart disease. We now need to assess the effectiveness of multiplex assays in normal clinical practice and to see whether these tests can predict which individuals are likely to develop problems with their coronary arteries in the future.

1. To assess the ability of new laboratory techniques (known as ‘multiplex assays’) to identify people who might be suffering from coronary atherosclerosis.

2 To perform a vast range of other laboratory tests with the aim of identifying specific molecules which could act as ‘markers’ (indicators) of coronary heart disease. We will also be assessing ‘risk factors’ which could predispose individuals to develop the disease.

We aim to enrol a total of 1,000 patients from hospitals throughout the UK. Hospitals where recruitment is underway, or due to start shortly, include Norfolk & Norwich, Peterborough, Hairmyres (Lanarkshire) and St. George’s (London).

Patients will be invited to take part in the study if they are attending one of the cardiology outpatient clinics for the first time and if they may be referred for a coronary angiogram or an angiography pre-assessment clinic. It is important for us to compare our research results with the results obtained from this procedure, therefore we are only approaching people who may be referred for an angiogram.

Each patient is consented into the study and then taken through a questionnaire to obtain some background information about their life (e.g. about your family background and whether you smoke etc.). The patient is asked to provide a small blood sample. At a later date your medical records will be accessed to obtain a detailed medical history and the results of your angiogram. Each patient’s details will be ‘flagged’ with the National Health Service Central Register (part of the General Register Office) and HES (Hospital Episode Statistics), allowing us to be informed of any major health incident affecting you in the future.

Data stored on computer, including all of the personal information about the patient (from both the questionnaire and the medical records), are anonymised. Neither the patient's name, address or hospital numbers are stored on this database, and the records are therefore identified solely by study number.

A master list of patient’s name vs. study number is kept by the clinical research assistant at each of the hospitals, and is not available to the scientists involved in the study.
In addition, all databases are password protected, and when not in use, all computers holding PUMA data are locked when not in use.

Where collaborations may be entered into between the PUMA study group and other scientists around the world, only the anonymous data may be distributed. In addition, prior to any data being passed on, the collaborating scientists must sign to state that they will not use any of the information in the database to attempt to identify any of the PUMA study participants.

Continued participation in the PUMA study may be withdrawn at any time. If at any time you feel that you no longer wish to be associated with the study, then please contact your local research nurse, at the hospital where you were recruited. Your blood samples, and all records (whether anonymised or not) will be destroyed.

In order to obtain a control population of people with which to compare the PUMA study patients, we will be writing to a random selection of the partners of PUMA study patients to ask them if they would also like to take part in PUMA. Please remember that this selection process is random, and therefore it is of no consequence if a patient’s partner is selected or not. In addition, it does not matter if they are healthy or not – our aim is to obtain a group of people who are representative of the patients themselves, but who are not currently being referred for a coronary angiogram.

Further information is available here.