Multiscale Modelling of Atherosclerosis (Version 1)

• Research type

  Research Study

• Full title

  Observational study of 20 patients on pharmaceutical therapy for hyperlipidemia and hypertension and its effects on the progression of plaque growth in atherosclerosis

• IRAS ID

  127524

• Contact name

  Vanessa Diaz

• Contact email

  v.diaz@ucl.ac.uk

• Sponsor organisation

  University College London

• Clinicaltrials.gov Identifier

  Z6364106/2013/10/02, UCL Data Protection Registration Number

• Research summary

  The purpose of this study is to observe the effect on the development of atherosclerotic plaque and to prove that cholesterol-lowering (atorvastatin) and blood pressure lowering (amlodipine) drugs halt the progress of plague growth in atherosclerosis. To do that, patient-specific longitudinal datasets are collected for the validation of a computational model of atherosclerosis.

  The study is split into four control groups depending on the drug given to the patient (Amlodipine only, Statin only, Amlodipine and Statin, no drugs such as Amlodipine or statin).

  The study for each control group is divided into four main sections, the screening period, baseline period, treatment phase and a final follow-up. he points below need to be noted:
  • Routine tests used to determine eligibility as defined in Inclusion/Exclusion criteria
  • Baseline visit will occur within 28 days of Screening visit
  • Follow-Up visits during the treatment phase should be every 3 months

  Inclusion Criteria:
  Patients both genders are eligible for entry into the study if they
  • Show signs of atherosclerotic plaque in the carotid artery
  • Are 50 years or older
  • Have a body mass index (BMI) over 25
  • Have either high blood pressure (systolic =130mmHg, diastolic =90mmHg) or/and hyperlipidemia with LDL cholesterol level = 130mg/dL

  Exclusion Criteria:
  Patients are not eligible for entry into the study if they
  • Are children
  • Are pregnant or breast-feeding
  • Have type II diabetes mellitus
  • Have liver disease or have a history of high alcohol intake
  • Have known allergies to any type of statin or calcium channel blocker
  

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  14/LO/1072

• Date of REC Opinion

  23 Sep 2014

• REC opinion

  Further Information Favourable Opinion