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Cardiac MR of Subclinical CVD: Impact of Age

Primary Purpose

Atherosclerosis, Heart Diseases, Cardiovascular Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Atherosclerosis

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Members of the Framingham Heart Study include the cohort first examined beginning in 1948, their offspring and spouses first examined between 1971 and 1975, and a minority population, the Omni cohort.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 8, 2002
    Last Updated
    July 28, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00041418
    Brief Title
    Cardiac MR of Subclinical CVD: Impact of Age
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2001 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To use magnetic resonance imaging to identify subclinical atherosclerosis and left ventricular hypertrophy in the Framingham Heart Study cohort.
    Detailed Description
    BACKGROUND: Coronary heart disease and stroke are leading causes of mortality for men and women in the United States. Current understanding of the pathogenesis of and the risk factors for cardiovascular disease (CVD) is derived largely from prospective studies of clinically overt disease. Unfortunately, clinical risk factors for CVD defined by these methods fail to predict a large proportion of CVD events, and some subjects at high clinical risk fail to develop overt disease. Subclinical disease precedes clinical by years/decades but is difficult to quantify. For example, left ventricular hypertrophy (LVH) and aortic atherosclerosis are strong predictors of CVD events, but are difficult to accurately non-invasively quantify, especially among the elderly and overweight subjects (both growing populations in the U.S.). MRI permits accurate assessment of cardiac anatomy/function and subclinical aortic atherosclerosis. DESIGN NARRATIVE: The underlying hypothesis of this study is that subclinical cardiovascular disease (CVD) is a precursor to overt CVD, and that magnetic resonance imaging (MRI) measures of subclinical aortic and cardiac anatomic disease are superior for the characterization of risk as compared with current measures of risk factors as well as more conventional imaging (e.g., carotid ultrasound, echo). Longitudinal/time-averaged indexes of all established risk factors for CVD have been collected in the Framingham Heart Study (FHS). These time-averaged indexes are stronger predictors of clinical CVD than single measures. In a Pilot study of 312 FHS Offspring subjects, MRI measures of LV mass were successfully acquired in a larger proportion of subjects than echo, and MR evidence of LVH and subclinical aortic disease correlated more strongly (than echo and carotid ultrasound measures) with these time-averaged indexes. Application of MRI methods in the FHS offers an opportunity to identify subclinical atherosclerosis and LVH in this well-characterized cohort and to relate these data with conventional imaging measures already acquired in this cohort. Importantly, the near-concurrent acquisition of brain MRI/neuropsychologic examination in the same FHS cohort offer the unique contemporaneous opportunity to examine subclinical cerebrovascular disease with MRI indexes of subclinical atherosclerosis. The study will expand the Pilot study to perform heart and thoracic/abdominal aorta MRI studies in 2400 FHS participants to allow for identification of individual CVD risk factors for subclinical atherosclerosis. These population-based data will extend knowledge of the distribution and severity of atherosclerosis in adult men and women and their relations to existing echo, carotid ultrasound and brain MRI measures. This study provides the rare opportunity to examine associations of quantitative MRI measures of aortic atherosclerosis and LVH with both cross-sectional and time-averaged measures of individual atherosclerotic risk factors (e.g., blood pressure, cigarette smoking, and cholesterol) and with novel inflammatory markers (e.g., C-reactive protein, MCP-1). Further, because the FHS consists of hundreds of sibships for which a DNA repository has been established, the heritability of MRI indexes of atherosclerosis and LVH will be determined, laying the groundwork for future genetic studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atherosclerosis, Heart Diseases, Cardiovascular Diseases, Hypertrophy, Left Ventricular

    7. Study Design

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Members of the Framingham Heart Study include the cohort first examined beginning in 1948, their offspring and spouses first examined between 1971 and 1975, and a minority population, the Omni cohort.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Warren Manning
    Organizational Affiliation
    Beth Israel Deaconess Medical Center

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35638924
    Citation
    Neisius U, Gona PN, Oyama-Manabe N, Chuang ML, O'Donnell CJ, Manning WJ, Tsao CW. Relation of MRI Aortic Wall Area and Plaque to Incident Cardiovascular Events: The Framingham Heart Study. Radiology. 2022 Sep;304(3):542-550. doi: 10.1148/radiol.210830. Epub 2022 May 31.
    Results Reference
    derived

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    Cardiac MR of Subclinical CVD: Impact of Age

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