Cardiovascular DiseaseMiHEARTNCT02508454
The Miami Heart Study at Baptist Health South Florida
An observational study of Cardiovascular Disease, run by Baptist Health South Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Sep 2028
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Keywords
- Prevention, Screening, Biobanking
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in presence of subclinical cardiovascular disease burden among cohort as measured through yearly followup questionnaire.
To assess and characterize the presence of subclinical cardiovascular disease burden among middle-aged asymptomatic individuals.
Measured: 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.
To assess and characterize the severity of subclinical cardiovascular disease burden among middle-aged asymptomatic individuals.
Measured: Participants will be followed yearly for 5 years following completion of thier baseline visit.
Secondary outcomes (1)
Associated cost savings of early discovery of disease.
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.
Measured: Participants will be followed yearly for 5 years following completion of thier baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Quest Diagnostics-Nichols Insitute, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Khurram Nasir, MD, MPH, Principal investigator, Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508454
- Sponsor's protocol ID
- 14-042
- Acronym
- MiHEART
- Status last verified
- May 2026
- First submitted
- 9 Jun 2015
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ichikawa K, Ronen S, Bishay R, Krishnan S, Benzing T, Kianoush S, Aldana-Bitar J, Cainzos-Achirica M, Feldman T, Fialkow J, Budoff MJ, Nasir K. Coronary Plaque Volume in an Asymptomatic Population: Miami Heart Study at Baptist Health South Florida. JACC Cardiovasc Imaging. 2026 Jan;19(1):49-60. doi: 10.1016/j.jcmg.2025.08.001. Epub 2025 Sep 8.
PubMed 40920149
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02508454
- Acronym / sponsor ID
- MiHEART / 14-042
- Conditions
- Cardiovascular Disease
- Keywords
- Prevention, Screening, Biobanking
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Quest Diagnostics-Nichols Insitute, University of California, Los Angeles
- Study start
- May 2015 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 Jul 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Associated cost savings of early discovery of disease.
Time frame: Participants will be followed yearly for 5 years following completion of thier baseline visit.
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 27 May 2026.
- Derived from this study: PubMed 40920149Ichikawa K, Ronen S, Bishay R, Krishnan S, Benzing T, Kianoush S, Aldana-Bitar J, Cainzos-Achirica M, Feldman T, Fialkow J, Budoff MJ, Nasir K. Coronary Plaque Volume in an Asymptomatic Population: Miami Heart Study at Baptist Health South Florida. JACC Cardiovasc Imaging. 2026 Jan;19(1):49-60. doi: 10.1016/j.jcmg.2025.08.001. Epub 2025 Sep 8.
- Miami Heart Study Website - EnglishLink provided by the sponsor.
- Miami Heart Study Website -EspañolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Khurram Nasir, MD, MPH principal investigator
Baptist Health South Florida
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 Cardiovascular Disease, run by Baptist Health South Florida 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 4 inclusion and 10 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 27 May 2026. 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?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02508454, which also lists 1 linked publication.
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 27 May 2026.