Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy
Condition: Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational [Patient Registry]

Summary: 
      Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on
      Long-Term Antiretroviral Therapy

      Intro:

      It is well known that HIV treated with antiretroviral drugs increases the risk for coronary
      artery disease. Studies have documented this with various methods including analyzing the
      effects of retroviral therapy on cardiac risk factors such as diabetes, lipids and
      hypertension. Still other studies have looked at carotid and brachial artery intimal
      thickness. Our study, then, aims to evaluate the relationship between HIV medications and
      coronary atherosclerosis using a novel method. Coronary artery CT angiography is a relatively
      new diagnostic procedure to evaluate heart disease in cardiac patients. We will apply this
      test to HIV patients on longstanding antiretroviral therapy to directly examine their
      coronary arteries to assess heart disease.

      Hypothesis:

      We hypothesize that HIV patients on antiretroviral therapy will have increased coronary
      artery disease compared to the general population.

      Methods:

      This project will be conducted in collaboration between Florida Heart Center and Associates
      in infectious Disease - two communities based infectious disease and cardiology practices. We
      will identify all the HIV positive patients seen within a 1 month timeframe at the infectious
      disease office. These patients will then be filtered by our exclusion/inclusion criteria.
      After obtaining informed consent, we will draw blood from each patient to gather lab values
      such as A1C, cholesterol, inflammatory markers, and other markers associated with coronary
      artery disease. Each enrolled patient will then schedule and receive a 64 slide coronary CTA
      at Florida Heart Center. The results of the CTA scans will be categorized in mild, moderate,
      and severe coronary artery disease. The data, then, will consist of the parameters measured
      on blood work, and the results of the coronary CTA.

      Inclusion Criteria:

      1. Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years.

      Exclusion Criteria:

      1. Patients with prior documented coronary artery disease, heart attack, stent placement, or
      heart surgery.

      Statistical Analysis:

      We will conduct a multivariate analysis on the cardiac risk factors taken from patient
      history and the bloodwork (diabetes, lipids etc) to correlate them with the results of the
      CTA. We will also conduct basic analysis to support our hypothesis that long term
      antiretroviral therapy increases coronary artery disease.

      Funding:

      The bloodwork and CTA tests ordered in this study will be payed for by insurance companies
      where available. In cases where insurance companies will not pay, Florida Heart Center will
      pay for the CTA tests and Associates in infectious Disease will fund the bloodwork.

      Humans Subjects Protection:

      This will be a projective chart review study that will require access to protected health
      information. Thus, we will seek full IRB approval from the FSU IRB committee with informed
      consent. An informed consent document will be given to each patient explaining all the risks
      and benefits of the study in addition to the methods. Recruitment will be done by an office
      staff or medical assistant not on the research team. After patient recruitment, their medical
      records will be flagged for study and they will undergo the required testing. At completion
      of testing, their results will be recorded in the final data sheet, and their medical record
      will no longer be flagged for study. No identifying data will be recorded in the final data
      sheet, and the data will be stored in an encrypted excel sheet on a secure password protected
      personal laptop running antivirus and firewall. Third parties (such as family members) will
      not have access to any research data regardless of authorizations received from the study
      subjects. All the test results and labwork performed for the study will go into the patient's
      individual medical record at their respective offices. Thus, if an authorized third party
      wishes to view any test results, they can do so via the normal methods at the doctor's
      office.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 35 to 50 with HIV and on antiretroviral therapy for at least 5 years. These
        patients also cannot have any documented history of coronary artery disease or cardiac
        interventions.