Using Quantitative Measures to Determine the Effectiveness of Standard of Care Preventative Treatments for Cardiovascular Disease in the Homeless
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-005192
Sponsor Protocol Number: 18-005192
About this study
The purpose of this study is to determine the effectiveness of intensive, guideline-directed, preventative therapies on cardiovascular disease in the homeless population to help develop an appropriate care model for preventing and treating CVD in the homeless.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- ≥ 18 years of age;
- Must meet definition of homeless as defined in the Health Act of 2009.
- Have 1 or more of the following:
- Documented CVD;
- A CVD 10-year risk at least 7.5% using the American College of Cardiology ASCVD Risk Estimator Plus;
- 2 or more CVD risk factors;
- CVD risk factors include advanced age, smoking history, family history of premature CVD in a first degree relative, hypertension, hyperlipidemia, diabetes.
Exclusion Criteria:
- Severe psychiatric illness defined by a licensed psychiatrist.
- Severe liver or muscle disease that precludes use of statins.
- Documented cirrhosis, or Hep B or Hep C infections, will serve as contraindication.
- Heavy alcohol abuse defined as drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days (SAMHSA 2015).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Brian Shapiro, M.D., M.A. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available