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Trial record 36 of 217 for:    heart disease AND stroke AND California

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

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ClinicalTrials.gov Identifier: NCT02508454
Recruitment Status : Recruiting
First Posted : July 27, 2015
Last Update Posted : January 31, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Cardiovascular Disease

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

Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : August 2014
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023
Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA

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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508454


Contacts
Contact: Khurram Nasir, MD, MPH 7866624937 khurramn@baptisthealth.net
Contact: Lara Arias, MPH 7866624937 laraar@baptisthealth.net

Locations
United States, Florida
West Kendall Baptist Hospital Medical Arts Building, Suite 103 Recruiting
Miami, Florida, United States, 33196
Contact: Lara Arias, MPH    786-662-4937    laraar@baptisthealth.net   
Contact: Janisse Post, RN, MSPH    7866624937    janissep@baptisthealth.net   
Principal Investigator: Khurram Nasir, MD,MPH         
Sponsors and Collaborators
Baptist Health South Florida
Quest Diagnostics
University of California, Los Angeles
Investigators
Principal Investigator: Khurram Nasir, MD, MPH Baptist Health South Florida
More Information

Additional Information:
Responsible Party: Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT02508454     History of Changes
Other Study ID Numbers: 14-042
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Baptist Health South Florida:
Prevention
Screening
Biobanking

Additional relevant MeSH terms:
Cardiovascular Diseases