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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vishal Dahya, Florida State University
ClinicalTrials.gov Identifier:
NCT02191306
First received: July 14, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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.


Condition
Our Study Aims to Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis Using Coronary Artery CT Angiography.

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Week

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • Calcium Score Measured from CT Angiography [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    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.

  • Increased Inflammatory Markers in Bloodwork [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Increased Inflammatory Markers on Lab Panel [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    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


Enrollment: 78
Study Start Date: October 2013
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
HIV Positive Patients (Study Group)
Non HIV Positive Patients (Control)

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02191306

Locations
United States, Florida
Associates in Infectious Disease
Fort Pierce, Florida, United States, 34950
Florida Heart Center
Fort Pierce, Florida, United States, 34950
Sponsors and Collaborators
Florida State University
  More Information

Additional Information:
Publications:
Responsible Party: Vishal Dahya, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier: NCT02191306     History of Changes
Other Study ID Numbers: IRB00000446
Study First Received: July 14, 2014
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Atherosclerosis
Arteriosclerosis
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014