Status:
COMPLETED
Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
HIV/AIDS
Cardiovascular Diseases
Eligibility:
All Genders
40+ years
Brief Summary
The goal of this research is to generate evidence-based recommendations for the management of cardiovascular disease (CVD) risk in People Living with HIV (PLWH). The overall objectives of this applica...
Detailed Description
To identify factors associated with cardiology referral in under-represented racial and ethnic minority (URM) populations with HIV and elevated cardiovascular risk
Eligibility Criteria
Inclusion
- Project is not recruiting as retrospective review of electronic health records.
- Inclusion Criteria:
- Patient health records may be accessed from subjects who meet the following criteria:
- Race equals Black/African-American, American Indian/Alaska Native, Asian, Native Hawaiian/Pacific Islander, or More than one race, and/or Ethnicity equals Hispanic or Latino;
- Documented evidence of HIV positive status (HIV positive diagnosis (ICD10 codes B20-B24, or ICD9 codes 042, V08) and prescription of antiretroviral therapy (ART));
- Documented evidence of elevated AtheroSclerotic CardioVascular Disease risk (ACC/AHA ASCVD 10 year risk ≥5%24, or Framingham Cardiovascular Disease 10 year risk ≥5%25) after HIV diagnosis. The date when the patient first meets either of these CVD risk thresholds and with 1 prior encounter not having CVD risk score defines the index time-point for Aim 1 of this study. These risk calculations depend on sex, age, body mass index, diabetes, current smoking, total cholesterol, HDL cholesterol, systolic blood pressure, and treatment for hypertension (defined from diagnosis codes). If cholesterol measures are not available, then body mass index may be used in place of lipids in the Framingham risk calculation; NOTE: must have a prior encounter within 365 days within health system prior to index
- Presence of a modifiable risk factor: hypertension, diabetes, elevated total cholesterol, elevated LDL cholesterol and/or tobacco use.
- Exclusion criteria:
- Age \<18 years of age or \>99 years of age at index event;
- Pre-existing ASCVD prior to index event, including a previous diagnosis of any acute myocardial infarction, heart failure, acute coronary syndromes, stable or unstable angina, arterial revascularization (includes coronary arterial or peripheral), stroke, transient ischemic attack or peripheral arterial disease presumed to be of atherosclerotic origin determined by ICD codes;
- Encounter with cardiology specialist within 1 year prior to index
- Evidence of ART for pre-exposure prophylaxis (i.e., Truvada \[emtricitabine/tenofovir disoproxil fumarate\] or post-exposure prophylaxis (e.g., Truvada plus raltegravir) without HIV diagnosis.
Exclusion
Key Trial Info
Start Date :
January 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
2039 Patients enrolled
Trial Details
Trial ID
NCT04025125
Start Date
January 1 2014
End Date
December 31 2020
Last Update
August 1 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University
Durham, North Carolina, United States, 27707