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NCT02191306 · ClinicalTrials.gov registry record
Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy
A clinical trial of Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis, sponsored by Florida State University.
- Completed
- Registry status
- 78
- Enrollment target
- 2
- Study locations
NCT02191306: Completed study of Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis, sponsored by Florida State University.
NCT02191306 is a study of Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis that has completed, run by Florida State University. The registered enrollment target is 78 participants. The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02191306, a study of Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis, has completed, sponsored by Florida State University.
- COMPLETED
- Registry status
- 78 participants
- Enrollment target
- 2
- Study locations
Study 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 o
Primary Outcome
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.
Study Locations (2)
Florida
- Associates in Infectious Disease - Ft. Pierce
- Florida Heart Center - Ft. Pierce
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-03 |
What the finished NCT02191306 record still lists
NCT02191306 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 78 participants, a relatively small participant target.
The record links to 1 condition, with Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis appearing as the primary indexed condition, and to 0 interventions.
NCT02191306 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02191306 about?
NCT02191306 is a clinical study titled "Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy". 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 includ...
What is the current status of trial NCT02191306?
This trial is currently completed. The enrollment target is 78 participants. The study started on 2013-10. Estimated completion is 2014-03.
What conditions does trial NCT02191306 study?
This clinical trial studies the following conditions: Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis.
Who is sponsoring clinical trial NCT02191306?
This trial is sponsored by Florida State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02191306 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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