Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy

April 19, 2022 updated by: Florida State University

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Pierce, Florida, United States, 34950
        • Associates in Infectious Disease
      • Fort Pierce, Florida, United States, 34950
        • Florida Heart Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years

Exclusion Criteria:

  • Patients with prior documented coronary artery disease, heart attack, stent placement, or heart surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
HIV Positive Patients (Study Group)
Non HIV Positive Patients (Control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium Score Measured from CT Angiography
Time Frame: 1 Day
Each CT Scan was analyzed and a calcium score was associate with each plaque lesion in the coronary arteries. This score correlates with the presence of coronary artery disease in the patient.
1 Day
Increased Inflammatory Markers in Bloodwork
Time Frame: 1 Day
The blood work taken from each HIV positive patient was run with a cardiovascular inflammatory marker panel which gave the researchers another measure of coronary artery disease
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased Inflammatory Markers on Lab Panel
Time Frame: 1 Day
The blood work taken from each HIV positive patient was run with a cardiovascular inflammatory marker panel which gave the researchers another measure of coronary artery disease
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00000446

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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