Beauty from Within Community Screening Project

NCT02588690 | Active Not Recruiting

• 1 other identifier: Pro00041183
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 1.Provide women with CVD risk stratification in places where they locally convene on a daily basis.
2. 2.To evaluate the efficacy of a lay professional to adequately assess CVD risk.
3. 3.To evaluate if assessment of CVD risk reduces the amount of future CVD (unsure if this can be measured in this project).
4. 4.Demonstrate feasibility and acceptability of strategies utilizing ASCVD risk assessment.
5. 5.Improve ASCVD risk scores one year follow-up.
6. 6.Increase heart disease awareness through marketing materials in women in Los Angeles.
7. 7.Develop preliminary feasibility and efficacy data for a large clinical outcome trial.

Conditions

Heart Health Screening and Prevention

Outcome Measures

Primary Outcomes (1)

• ASCVD Risk Score

  Comparing ASCVD Risk Score calculated during initial visit and a score calculated in one year.

  One year

Study Arms (1)

Women participating in screening

Community screening project targets women of color and/or low income women over 21 years of age in economically and ethnically diverse greater Los Angeles community. Women will be risk stratified based on ASCVD risk calculation and if labeled high risk will be referred to physician services. In 1 year, women will have their ASCVD re-risk stratify to see if seeing a physician/ health care provider reduced overall ASCVD risk scores.

Procedure: Fingerstick cholesterol test; Other: Atherosclerosis Cardiovascular Disease Risk assessment; Procedure: Blood pressure measurement

Interventions

Fingerstick cholesterol test PROCEDURE

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.

Women participating in screening

Atherosclerosis Cardiovascular Disease Risk assessment OTHER

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.

Also known as: ASCVD Risk Score

Women participating in screening

Blood pressure measurement PROCEDURE

Blood pressure measurement

Women participating in screening

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community screening project targets women of color and/or low income women in economically and ethnically diverse greater Los Angeles community

You may qualify if:

• women over the age of 21

You may not qualify if:

• Children under the age of 21 years
• Pregnant women

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Women's Heart Center

Los Angeles, California, 90048, United States

Location

Study Officials

• C.Noel Bairey Merz, MD, FACC

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 28, 2015
• Study Start: November 1, 2015
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)