Pathways to Cardiovascular Disease Prevention (DCRI Central and Statistical Coordinating Center)

Duke University

Status: Completed

Conditions: Cardiovascular Diseases; HIV/AIDS

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04025125

Pro00101104

1R01MD013493-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 application are to demonstrate the effect of cardiology referral on CVD outcomes in a racially/ethnically diverse cohort of PLWH, and to generate qualitative data with which to develop of a future intervention. Our central hypothesis is that cardiology referral reduces incident CVD events in underrepresented racial/ethnic minority (URM) populations with HIV compared to nonreferral. Our hypothesis has been formulated based on our own work identifying that race and provider specialty impact cardiovascular risk management. The rationale for our research is that, once it is known how URM populations with HIV access cardiology referrals, and the impact on CVD outcomes, an intervention can be appropriately designed resulting in new and innovative approaches to the management of URM PLWH at elevated CVD risk.

Full description

To identify factors associated with cardiology referral in under-represented racial and ethnic minority (URM) populations with HIV and elevated cardiovascular risk

Enrollment: 2,039 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

1. 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;
2. Documented evidence of HIV positive status (HIV positive diagnosis (ICD10 codes B20-B24, or ICD9 codes 042, V08) and prescription of antiretroviral therapy (ART));
3. 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
4. Presence of a modifiable risk factor: hypertension, diabetes, elevated total cholesterol, elevated LDL cholesterol and/or tobacco use.

Exclusion criteria:

1. Age <18 years of age or >99 years of age at index event;
2. 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;
3. Encounter with cardiology specialist within 1 year prior to index
4. 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.

Trial design