Anglo-Scandinavian Cardiac Outcomes Trial: Post Trial Follow-Up Study
Condition: Hypertension; Diabetes; Death From Cardiovascular Disease; Myocardial Infarction; Stroke
MeSH terms: Hypertension; Cardiovascular Diseases; Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      ASCOT-10 is a follow-up study of surviving participants in the United Kingdom (UK)arm of the
      Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) which was conducted between 2000 and
      2005.ASCOT's results showed substantial cardiovascular benefit from: 1) the use of a
      cholesterol lowering drug (atorvastatin) compared to placebo, and 2) the use of a
      blood-pressure lowering strategy based on amlodipine when compared to a strategy based on
      atenolol. ASCOT-10 will test the hypothesis that the ASCOT subjects who originally received
      Atorvastatin and those who received amlodipine based treatment will continue to show a
      cardiovascular benefit relative to those who did not, even though all the subjects have had
      access to optimal treatment in the interim.
    

Detailed description: 
      Study investigators will have access to information about ASCOT patients from their study
      centre who have died since the end of the ASCOT study in 2005. Of the 8580 ASCOT patients
      from the United Kingdom, 7300 were flagged with The Information Centre for Health and Social
      Care at the end of the trial in 2005.This flagging process was re-activated in 2010 so that
      all deaths and incident cancers relating to these patients are now sent every three months to
      the ASCOT-10 co-ordinating centre. These results are identified by the ASCOT study number,
      with all personal data removed. These deceased patient numbers will be communicated to the
      participating sites so that the trial centre staff will not contact their families.

      An attempt will be made to contact all remaining patients from the participating UK ASCOT
      sites.

      Initial contact will be made via the general practitioner (GP) surgery. If the GP can provide
      up-to-date contact details and feels that it is appropriate to contact the patient, patients
      will then be sent an introductory letter, a patient information sheet, a consent form and a
      health questionnaire.

      They will be asked to complete a 'tick-box' form given the following options:

        1. Willing to complete health questionnaire.

        2. Willing for information about health to be given by GP or next of kin.

        3. Willing to give information by telephone only.

        4. Willing to attend study clinic for a single visit.

        5. Not willing to take part.

      They will be asked to complete this form, sign, date and return in a pre-paid envelope to
      their trial centre. This form will be used as the consent form for the questionnaire part of
      the study.

      They will also be asked to complete a simple health questionnaire. This will collect
      information on any health problems experienced since the end of the ASCOT trial (in
      particular about heart attacks and strokes/mini-strokes), as well as information on any
      hospital admissions during this period and current medication. In addition, information about
      current weight, exercise, alcohol consumption, smoking and general quality of life will be
      collected. Patients will be asked to return their completed questionnaire, along with their
      consent/reply form, to their local trial centre.

      If the study team have not received a response within four weeks, a further reminder letter
      will be sent. If no response has been obtained after a further four weeks, a final attempt
      will be made to contact the patient by letter or telephone call.

      10% of the study population from each trial centre, who will be chosen at random, will be
      invited to attend their trial centre for a single clinic visit. Further informed consent
      following discussion with member(s) of the study team will be obtained. During the clinic
      visit the questionnaire will be reviewed and several further measurements will be taken as
      follows:

        -  Blood pressure

        -  Weight

        -  Pulse wave analysis. (This is a simple, non-invasive test, very much like a blood
           pressure measurement, that gives us further information on the function of the heart and
           arteries)

        -  Blood for creatinine and estimated glomerular filtration rate(eGFR)(tests of kidney
           function), electrolytes (sodium and potassium), fasting lipids (cholesterol), fasting
           glucose, glycated haemoglobin (a further test for diabetes) An additional blood test
           will be taken and plasma stored for the later analysis of chemicals in the blood which
           might predict cardiovascular risk. Precise details of this further testing are not
           currently available. However, the plasma will be stored securely and no identifiable
           data will be present on the samples (i.e. they will be stored anonymously, identified
           only by the subject's study number).

      Every effort will be taken to contact patients who have moved since the ASCOT study closed
      and for whom no contact details are available. This may be done by health service tracking
      services, where available, or via Primary Care Trusts (PCTs).
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who participated in the Anglo-Scandinavian Cardiac Outcomes Trial in the UK
      
Biospecimen description: 
      Plasma to be stored for future measurement of biochemical markers of cardiovascular disease
    
Keywords: Hypertension; Mortality; Morbidity; Coronary Heart Disease; Stroke; Diabetes