The Miami Heart Study at Baptist Health South Florida
MiHEART
1 other identifier
observational
4,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 9, 2015
CompletedFirst Posted
Study publicly available on registry
July 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
May 2, 2025
April 1, 2025
12.3 years
June 9, 2015
April 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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.
Participants will be followed yearly for 5 years following completion of thier baseline visit.
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baptist Health South Floridalead
- Quest Diagnostics-Nichols Insitutecollaborator
- University of California, Los Angelescollaborator
Study Sites (1)
Raul Herrera
Miami, Florida, 33176, United States
Related Publications (1)
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.
PMID: 40920149DERIVED
Related Links
Biospecimen
Approximately 115 mls of blood will be drawn by a Registered Nurse. Blood samples will be tested for markers of the diseases and health conditions under investigation. These will include standard markers (cholesterol, blood sugar, etc) and novel markers which are not commonly evaluated by a physician. Additionally, any remaining blood samples will be stored and kept for future risk factor evaluation, biomarker testing and genetic studies. Whole blood and serum will be retained.
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Khurram Nasir, MD, MPH
Baptist Health South Florida
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2015
First Posted
July 27, 2015
Study Start
May 1, 2015
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2028
Last Updated
May 2, 2025
Record last verified: 2025-04