Beauty from Within Community Screening Project

NCT02588690 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-09-19

No results posted yet for this study

Summary

Cardiovascular disease (CVD) is the leading cause of death world-wide in women. Despite current medical advances, heart disease is rising in relatively young women. Women access primary care differently than men, most utilizing their Obstetrics-gynecology clinic for primary care services. The recent implementation of the Affordable Care Act (ACA) aims to provide increased access to primary care services, however, women are still not appropriately risk stratified for CVD disease risk. Many women still are not aware that they are at risk for CVD. This is particularly true for the 15-44 year old female age group. Lack of proper risk stratification may be related to women not being properly identified or appropriately referred to preventive cardiovascular services for treatment of traditional risk factors such as diabetes, obesity, hypertension, and dyslipidemia. These traditional risk markers serve as examples of chronic diseases, which are not always recognized in the early stages and therefore not optimally managed. Furthermore, if women are not feeling ill, they are less likely to access their current primary care resources for preventive strategies. Investigators propose to risk stratify women in places where they usually congregate. In addition to convenience, current risk stratification is improved with the recent implementation of the ASCVD risk calculator. Investigators hypothesize that if women were properly risk stratified and referred to appropriate preventive cardiovascular risk clinics, more preventive strategies could be implemented, therefore reducing the amount of unnecessary premature disease in women. To achieve this ambitious goal, investigators propose a three step, demonstration project.

The specific aims of this proposal is to:

1. Provide women with CVD risk stratification in places where they locally convene on a daily basis.
2. To evaluate the efficacy of a lay professional to adequately assess CVD risk.
3. To evaluate if assessment of CVD risk reduces the amount of future CVD (unsure if this can be measured in this project).

The specific aims:

1. Demonstrate feasibility and acceptability of strategies utilizing ASCVD risk assessment.
2. Improve ASCVD risk scores one year follow-up.
3. Increase heart disease awareness through marketing materials in women in Los Angeles.
4. Develop preliminary feasibility and efficacy data for a large clinical outcome trial.

Conditions

  • Heart Health Screening and Prevention

Interventions

PROCEDURE

Fingerstick cholesterol test

A finger stick draws approximately four drops of blood. The total cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C), Triglycerides, Low Density Cholesterol (LDL-C), and Glucose tests are done.

OTHER

Atherosclerosis Cardiovascular Disease Risk assessment

This Risk Estimator enables estimation of 10-year and lifetime risks for atherosclerotic cardiovascular disease (ASCVD), defined as coronary death or nonfatal myocardial infarction, or fatal or nonfatal stroke, based on the Pooled Cohort Equations and lifetime risk prediction tools. The Risk Estimator is intended for use in those without ASCVD with a LDL-cholesterol \<190 mg/dL. The information required to estimate ASCVD risk includes age, sex, race, total cholesterol, HDL cholesterol, systolic blood pressure, blood pressure lowering medication use, diabetes status, and smoking status.

PROCEDURE

Blood pressure measurement

Blood pressure measurement

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • C.Noel Bairey Merz, MD, FACC · Cedars-Sinai Medical Center

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2030-11-30
Completion
2030-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02588690 on ClinicalTrials.gov