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临床试验/NCT04025125
NCT04025125已完成不适用

Pathways to Cardiovascular Disease Prevention and Impact of Specialty Referral in Underrepresented Racial/Ethnic Minorities With HIV (Coordinating Center)

Duke University2 个研究点 分布在 1 个国家目标入组 2,039 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,039
试验地点
2
主要终点
Number of Participants With Visit to a Cardiology Specialist From Cohort

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Number of Participants With Visit to a Cardiology Specialist From Cohort

时间窗: 5 years

A binary variable, with 'yes' defined if there is documented evidence that a ambulatory visit was made with a cardiologist after becoming eligible by CVD risk score, and 'no' otherwise. Patients were followed from the date when they met eligibility criteria to the date of first encounter with a cardiology specialist or through a maximum of 5 years from their eligibility date. Follow-up was censored early at the end of data collection (December 31, 2020), or 6 months after the patient's last ambulatory visit, if earlier.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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