Clinical trial NCT02508454: The Miami Heart Study at Baptist Health South Florida
Official title: The Miami Heart Study at Baptist Health South Florida: A Prospective Study of Sub-Clinical Cardiovascular Disease and Emerging Cardiovascular Risk Factors in Asymptomatic Young & Middle-Aged Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiovascular Disease
Keywords: Prevention
Screening
Biobanking
Lead sponsor: Baptist Health South Florida
Sponsor class: OTHER
Collaborators: name: Quest Diagnostics-Nichols Insitute
name: University of California, Los Angeles
First posted: 2015-07-27
Enrollment: 4000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Since the MiHEART Study is primarily concerned with the determinants and natural history of subclinical cardiovascular disease, participants with known clinical disease will not be recruited. Most exclusion criteria relate to the long-term nature of the study or to incompatibility with certain study procedures. Eligibility (or ineligibility) status will be determined from self-reported information.

Brief summary: The Miami Heart Study at Baptist Health will be an observational, longitudinal and prospective cohort study in a target population of 4000 healthy subjects (40-65 years old) consisting of members from the Greater Miami Area (including eligible BHSF(Baptist Health South Florida) employees). Baseline examination will consist of (1) assessment for cardiovascular risk factors (including lifestyle and psychosocial factors); (2) screening for subclinical atherosclerosis using Coronary CT angiogram, Coronary Artery Calcium (CAC) testing, vascular 2D/3D ultrasound, endothelial function, arterial stiffness and (3) blood sampling for determination of traditional risk factors, advanced "omics" and biobanking. Participants will be followed yearly via telephone, email, or mail for change in health status with a focus on cardiovascular disease events, including acute myocardial infarction and other forms of coronary heart disease (CHD), stroke, and congestive heart failure; mortality; and for cardiovascular disease interventions.

The Miami Heart Study at Baptist Health is expected to identify new imaging and biological factors associated with the presence and feature of earliest markers of subclinical atherosclerotic disease and provide opportunities for discovery/validation of novel biomarkers to identify these high-risk features. This is expected to lead to advances in understanding of evolution and progression of atherosclerotic cardiovascular disease starts with an ultimate goal of establishing more personalized, evidence-based approach to medical care.

Detailed description: What is this study about? The Miami Heart Study is a long term observational research study which is designed to identify new and novel relationships between risk factors, genetics, lifestyle behaviors and cardiovascular disease in the greater Miami area. Miami is uniquely situated to capture a diverse, multi-ethnic population. As an employee of Baptist Health and a very important stakeholder in Baptist Health's mission, you are being asked to take part in this research study. The investigators expect approximately 4,000 members of the South Florida community and/or employees of Baptist Health to participate in this study over the next 5 years.

The research study aims to better understand heart disease and what causes it. Heart disease often starts many years before a person has a heart attack or develops symptoms of heart disease. This is called subclinical disease - and it refers to heart disease and the body processes causing heart disease, at a stage before any symptoms are experienced. Although doctors and researchers have a good understanding of heart disease in some areas, subclinical disease is not very well understood.

Better understanding subclinical disease can allow doctors and healthcare staff to intervene and prevent the process from developing further and causing symptomatic (with symptoms) heart disease. Progression refers to the process by which subclinical (without symptoms) heart disease develops into clinical (with symptoms) disease.

Therefore, the purpose of this research study is to:

* To examine the presence and severity of subclinical disease in the South Florida community.
* To examine what unique factors contribute to development of subclinical disease and appearance of clinical symptoms.

In the future, the investigators hope this information will allow us to better predict and prevent the development heart disease in diverse populations. Participants will be asked to come to the Miami Heart Study clinic for an examination that may take 4 to 6 hours to complete. During the examination, information about the participant's health will be collected and standard procedures routinely done a physician's office such as height, weight, and blood pressure will be performed.

Eligibility criteria: Inclusion Criteria:

* Current full time/part-time employees of BHSF (occupational cohort) or resident of Greater Miami Area for at least six months (community cohort)
* Age 40 to 65 years
* Asymptomatic individuals free of any known cardiovascular event
* Able to comprehend and sign an informed consent form

Exclusion Criteria:

* Prior history of major cardiovascular events (angina, myocardial infarction, prior coronary revascularization)
* History of cerebrovascular disease including stroke and transient ischemic attack (TIA)
* History of peripheral arterial disease (PAD)
* History of either diagnosis or surgery for Abdominal Aortic Aneurysm (AAA)
* Heart failure
* Weight greater than 350 lbs
* Any contraindication to CT scans or iodinated contrast
* Active treatment for cancer
* Currently pregnant, breastfeeding, or suspect they may be pregnant.
* Patients who do not agree to an informed consent

Primary outcomes:
measure: Change from baseline in presence of subclinical cardiovascular disease burden among cohort as measured through yearly followup questionnaire.
timeFrame: Participants will be followed yearly for 5 years following completion of thier baseline visit.
measure: Change from baseline in severity of subclinical cardiovascular disease burden among cohort as measured through yearly followup questionnaire.
timeFrame: Participants will be followed yearly for 5 years following completion of thier baseline visit.
Secondary outcomes:
measure: Associated cost savings of early discovery of disease.
timeFrame: Participants will be followed yearly for 5 years following completion of thier baseline visit.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Raul Herrera
state: Florida
Study officials:
affiliation: Baptist Health South Florida
name: Khurram Nasir, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: