The Miami Heart Study at Baptist Health South Florida (MiHEART)

May 22, 2026 updated by: Baptist Health South Florida

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Raul Herrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Greater Miami Area Community
Members of the Miami area who qualify for the study, are not an employee of BHSF, and enroll.
Baptist Health South Florida Employees
Employees of BHSF who qualify for the study and enroll.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in presence of subclinical cardiovascular disease burden among cohort as measured through yearly followup questionnaire.
Time Frame: Participants will be followed yearly for 5 years following completion of thier baseline visit.
To assess and characterize the presence of subclinical cardiovascular disease burden among middle-aged asymptomatic individuals.
Participants will be followed yearly for 5 years following completion of thier baseline visit.
Change from baseline in severity of subclinical cardiovascular disease burden among cohort as measured through yearly followup questionnaire.
Time Frame: Participants will be followed yearly for 5 years following completion of thier baseline visit.
To assess and characterize the severity of subclinical cardiovascular disease burden among middle-aged asymptomatic individuals.
Participants will be followed yearly for 5 years following completion of thier baseline visit.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associated cost savings of early discovery of disease.
Time Frame: Participants will be followed yearly for 5 years following completion of thier baseline visit.
To develop population-based methods for characterizing cardiovascular risk among middle-aged asymptomatic persons as well cost effectiveness for such paradigms in appropriately resource allocation for early cardiovascular disease management.
Participants will be followed yearly for 5 years following completion of thier baseline visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baptist Health South Florida

Collaborators

University of California, Los Angeles
Quest Diagnostics-Nichols Insitute

Investigators

  • Principal Investigator: Khurram Nasir, MD, MPH, Baptist Health South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimated)

July 27, 2015

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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