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Heart Attack-Clinical trial details-NHS Choices
NHS Choices - 2011 - Interventions: This is an observational cohort study where participants will undergo standard diagnostic tests but no pharmacological, surgical or lifestyle interventions will be made. Study 1: What is the spectrum of cardiac target organ damage seen in those with an ...
Interventions: This is an observational cohort study where participants will undergo standard diagnostic tests but no pharmacological, surgical or lifestyle interventions will be made. Study 1: What is the spectrum of cardiac target organ damage seen in those with an elevated BNP level? The Participants will all undergo a full clinical assessment including 24 hour BP monitoring. In addition, blood samples will be taken for the following: 1. Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides (fasting) 2. BNP, N-terminal BNP and N-terminal Atrial Natriuretic Peptide (ANP). BNP will be measured by a near patient BNP test (Biosite®) and by a standard radioimmunoassay (RIA) on a sample stored at -70 C° using the Peninsula® kit. N-terminal ANP and N-terminal BNP will also be measured by commercially available RIA kits. 3. Kidney function will be measured in three ways 4. Microalbuminuria. We will also be able to assess the value of measuring both BNP and microalbuminuria to identify cardiac target organ damage (TOD). 5. Electocardiogram (ECG) and 24 hour ECG tape to identify paroxysmal arrhythmias, especially atrial fibrillation (AF) 6. Echocardiography for target organ damage. All measurements will be made according to the American Society of Echocardiography (ASE) recommendation. 7. Silent coronary disease. A non-invasive technique is obviously necessary. We have opted for a dual approach, i.e. dobutamine stress echocardiography (DE) with nuclear stress perfusion imaging (SPI) as a back-up. The recent ACC/AHA 2002 guidelines for chronic stable angina were our guide in choosing techniques. 8. Cardiac MRI. This will be done in suitable patients identified at this stage, i.e. 76 individuals without any target organ damage. This is mainly so that we have baseline data to be used later for Study 2. Study 2: Does an elevated BNP in the absence of current ischaemia, LVH or LAD identify those who will later develop LVH or LAD? Effectively, a similar study to Study 1 will be repeated in some of the same individuals four years later. The main analysis will be whether LVMI and LAD progress more over 4 years in those with high tercile BN Ps than in those with low tercile BN Ps when both groups are matched for their baseline LVMI and LAD. It is best when studying intraindividual changes in LVMI (or LAD) to use the more sensitive technique of MRI. The prime aim of Study 2 is to see if a high BNP could identify those whose LV mass and/or whose LA volume will increase more in the next 4 years as detected by MRI. We shall also for completeness see if BNP also identifies those who will develop new (silent) coronary disease and stress echo will be undertaken. In addition, for completeness a delayed gadolinium enhancement on MRI will be added to the standard LV quantitative MRI assessment as a validated way of detecting old myocardial infarctions (M Is). These will be done in both the initial MR and the follow up MR but only in those patients taking part in Study 2. Please use the following contact details to request a patient information sheet: Dr Adnan Nadir MBBS, MRCP British Heart Foundation Research Fellow Division of Medicine & Therapeutics Ninewells Hospital & Medical School University of Dundee, Dundee DD19SY, UK Tel: +44 (0)1382 632 180 Fax: +44 (0)1382 644 972 Key inclusion and exclusion criteria:Primary outcomes: Study 1: The spectrum of cardiac target organ damage seen in those with an elevated BNP level Study 2: Proportion of participants with elevated BNP in the absence of ischaemia, LVH or LAD who develop LVH or LAD at four years Secondary outcomes: No secondary outcome measures Target sample size: 300 Study type: Observational Study design: Observational, cohort study. Contacts:
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Heart Attack-Clinical trial details-NHS Choices |
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