Heart Health Screening and PreventionBFWNCT02588690
Beauty from Within Community Screening Project
An observational study of Heart Health Screening and Prevention, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Health Screening and Prevention
- What is being tested?
- Fingerstick cholesterol test, Atherosclerosis Cardiovascular Disease Risk assessment and Blood pressure measurement
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community screening project targets women of color and/or low income women in economically and ethnically diverse greater Los Angeles community
Who may be able to join
- women over the age of 21
Who cannot join
- Children under the age of 21 years
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Women's Heart Center
Los Angeles, California, 90048
About this study
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:
Read more
- Provide women with CVD risk stratification in places where they locally convene on a daily basis.
- To evaluate the efficacy of a lay professional to adequately assess CVD risk.
- 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:
- Demonstrate feasibility and acceptability of strategies utilizing ASCVD risk assessment.
- Improve ASCVD risk scores one year follow-up.
- Increase heart disease awareness through marketing materials in women in Los Angeles.
- Develop preliminary feasibility and efficacy data for a large clinical outcome trial.
Read the detailed description
ACTIVITIES PLANNED FOR OCTOBER 2015 THROUGH DECEMBER 2015
- October 2015: The Barbra Streisand Women's Heart Center (BSWHC) research team will work closely with the Preventive Cardiovascular Nurses Association (PCNA), Los Angeles (LA) Chapter as well as the community partners will develop a detailed, comprehensive screening, education, referral and ASCVD tool kit. The tool kit will include a basic demographic screening questionnaire, smart-phone ASCVD risk calculator software, cholestech finger stick supplies, blood pressure equipment, Heart Truth program materials, and Red dress pins. Educational materials developed by all partners for each community highlighting Heart Truth branding will be included. A list and specific contacts for proximate California Affordable Care Act (ACA) Community Medical Homes will be included.
- October 2015: 2 women heart disease patient volunteers from Central and/or East Los Angeles will travel to the Mayo Clinic through the WomenHeart Program for public speaking and peer group leadership training.
- November 2015: The 88th Street Temple Church in central Los Angeles will help develop a detailed screening tool kit with training, educational materials and collaboration with Cedars-Sinai Medical Center (CSMC) staff to perform 100 ASCVD risk assessments after church services.
- DECEMBER 2015: The Hadassah Zionist Women's Group, Los Angeles Chapter will host a mall walking event targeting Orthodox Jewish women for screening. They will help develop a detailed screening tool kit with training, educational materials and collaboration by CSMC staff to perform 100 ASCVD risk assessments.
ACTIVITIES PLANNED FOR JANUARY 2016 THROUGH MAY 2016
- February 2016: The CSMC Heart Truth, Wear Red Day Event: Our 2015 Heart Truth/Wear Red Day event had over 600 attendees and screened 200 women CSMC employees. If funded, the 2016 program will be open to the public.
- February 2016: Beauty Shop Screenings. 3 local nursing organization chapters (Hispanic Nurses Society Los Angeles Chapter, Black Nurses Society LA Chapter, and Philippine Nurses Association of Southern California) will individually host a screening day in a community hair salon for at least 100 women at each site. This project is modeled after the National Heart, Lung, and Blood Institute (NHLBI)-sponsored Cedars-Sinai (CS) Barber-1 project which demonstrated blood pressure reduction in African American men using their barber as health educator. Each organization will receive a screening tool kit with training, educational materials and collaboration with CSMC staff.
- May 2016: CSMC Telemundo Community Outreach Program. Nearly 1,500 Latino women were screened last year at the CSMC Telemundo event. The investigators will utilize the screening tool kit with intensive training, educational materials and close collaboration with CSMC staff. The theme of the 2016 event will be The Heart Truth: for women by women.
- May 2016: Mother's Day Dinner and Health Fair at Jordan Downs Housing Development. CSMC Coach for Kids will host an annual Mother's Day Dinner for approximately 200 women at the Jordan Downs (public) Housing Development in Central Los Angeles. The community is low-income with approximately 50% African American and 50% Latino ethnicity. A health lecture (presented in both English and Spanish) and a health fair will utilize the detailed screening tool kit with Heart Truth materials.
- Conditions
- Heart Health Screening and Prevention
- Being tested
- Fingerstick cholesterol test, Atherosclerosis Cardiovascular Disease Risk assessment, Blood pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingerstick cholesterol testProcedure or surgery
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.
Atherosclerosis Cardiovascular Disease Risk assessmentOther
Also called ASCVD Risk Score
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.
Blood pressure measurementProcedure or surgery
Blood pressure measurement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Fingerstick cholesterol test; Other: Atherosclerosis Cardiovascular Disease Risk assessment; Procedure: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASCVD Risk Score
Comparing ASCVD Risk Score calculated during initial visit and a score calculated in one year.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Health Screening and PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Bairey Merz, Cedars-Sinai Medical Center
- Investigators
- C.Noel Bairey Merz, MD, FACC, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588690
- Sponsor's protocol ID
- Pro00041183
- Acronym
- BFW
- Status last verified
- Sep 2024
- First submitted
- 19 Oct 2015
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beauty from Within Community Screening Project
- ClinicalTrials.gov ID
- NCT02588690
- Acronym / sponsor ID
- BFW / Pro00041183
- Conditions
- Heart Health Screening and Prevention
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Provide women with CVD risk stratification in places where they locally convene on a daily basis.
- To evaluate the efficacy of a lay professional to adequately assess CVD risk.
- 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:
- Demonstrate feasibility and acceptability of strategies utilizing ASCVD risk assessment.
- Improve ASCVD risk scores one year follow-up.
- Increase heart disease awareness through marketing materials in women in Los Angeles.
- Develop preliminary feasibility and efficacy data for a large clinical outcome trial.
Detailed description
ACTIVITIES PLANNED FOR OCTOBER 2015 THROUGH DECEMBER 2015
- October 2015: The Barbra Streisand Women's Heart Center (BSWHC) research team will work closely with the Preventive Cardiovascular Nurses Association (PCNA), Los Angeles (LA) Chapter as well as the community partners will develop a detailed, comprehensive screening, education, referral and ASCVD tool kit. The tool kit will include a basic demographic screening questionnaire, smart-phone ASCVD risk calculator software, cholestech finger stick supplies, blood pressure equipment, Heart Truth program materials, and Red dress pins. Educational materials developed by all partners for each community highlighting Heart Truth branding will be included. A list and specific contacts for proximate California Affordable Care Act (ACA) Community Medical Homes will be included.
- October 2015: 2 women heart disease patient volunteers from Central and/or East Los Angeles will travel to the Mayo Clinic through the WomenHeart Program for public speaking and peer group leadership training.
- November 2015: The 88th Street Temple Church in central Los Angeles will help develop a detailed screening tool kit with training, educational materials and collaboration with Cedars-Sinai Medical Center (CSMC) staff to perform 100 ASCVD risk assessments after church services.
- DECEMBER 2015: The Hadassah Zionist Women's Group, Los Angeles Chapter will host a mall walking event targeting Orthodox Jewish women for screening. They will help develop a detailed screening tool kit with training, educational materials and collaboration by CSMC staff to perform 100 ASCVD risk assessments.
ACTIVITIES PLANNED FOR JANUARY 2016 THROUGH MAY 2016
- February 2016: The CSMC Heart Truth, Wear Red Day Event: Our 2015 Heart Truth/Wear Red Day event had over 600 attendees and screened 200 women CSMC employees. If funded, the 2016 program will be open to the public.
- February 2016: Beauty Shop Screenings. 3 local nursing organization chapters (Hispanic Nurses Society Los Angeles Chapter, Black Nurses Society LA Chapter, and Philippine Nurses Association of Southern California) will individually host a screening day in a community hair salon for at least 100 women at each site. This project is modeled after the National Heart, Lung, and Blood Institute (NHLBI)-sponsored Cedars-Sinai (CS) Barber-1 project which demonstrated blood pressure reduction in African American men using their barber as health educator. Each organization will receive a screening tool kit with training, educational materials and collaboration with CSMC staff.
- May 2016: CSMC Telemundo Community Outreach Program. Nearly 1,500 Latino women were screened last year at the CSMC Telemundo event. The investigators will utilize the screening tool kit with intensive training, educational materials and close collaboration with CSMC staff. The theme of the 2016 event will be The Heart Truth: for women by women.
- May 2016: Mother's Day Dinner and Health Fair at Jordan Downs Housing Development. CSMC Coach for Kids will host an annual Mother's Day Dinner for approximately 200 women at the Jordan Downs (public) Housing Development in Central Los Angeles. The community is low-income with approximately 50% African American and 50% Latino ethnicity. A health lecture (presented in both English and Spanish) and a health fair will utilize the detailed screening tool kit with Heart Truth materials.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women participating in screening | – | Procedure: Fingerstick cholesterol test, Other: Atherosclerosis Cardiovascular Disease Risk assessment, Procedure: Blood pressure measurementCommunity 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community screening project targets women of color and/or low income women in economically and ethnically diverse greater Los Angeles community
Key inclusion criteria (1 listed)
- women over the age of 21
Key exclusion criteria (2 listed)
- Children under the age of 21 years
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fingerstick cholesterol testA 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. | Procedure or surgery | Women participating in screening |
| Atherosclerosis Cardiovascular Disease Risk assessmentAlso: ASCVD Risk ScoreThis 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. | Other | Women participating in screening |
| Blood pressure measurementBlood pressure measurement | Procedure or surgery | Women participating in screening |
Primary outcome
ASCVD Risk Score
Time frame: One year
Comparing ASCVD Risk Score calculated during initial visit and a score calculated in one year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.Noel Bairey Merz, MD, FACC principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Health Screening and Prevention, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ASCVD Risk Score (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.