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AtherosclerosisNCT00041418

Cardiac MR of Subclinical CVD: Impact of Age

An observational study of Atherosclerosis and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To use magnetic resonance imaging to identify subclinical atherosclerosis and left ventricular hypertrophy in the Framingham Heart Study cohort. Read more about this study

Who is it for?
Ages Up to 100 years
How many people
Not given
Where
No sites listed yet
Study dates
Sep 2001to Aug 2006
Phase
Observational
Are there results?
None posted in the registry

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 Up to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

About this study

To use magnetic resonance imaging to identify subclinical atherosclerosis and left ventricular hypertrophy in the Framingham Heart Study cohort.

Read the 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.

Medical subject headings
Atherosclerosis, Heart Diseases, Cardiovascular Diseases, Hypertrophy, Left Ventricular

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2002 (estimated)
  2. Study startSep 2001
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00041418
Sponsor's protocol ID
1180
Other IDs
R01HL070279
Status last verified
Jan 2008
First submitted
8 Jul 2002
Last updated
29 Jul 2016
Results posted
No

Publications

  • 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.

    PubMed 35638924

Questions about this trial

What is this clinical trial studying?

An observational study of Atherosclerosis and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00041418, 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 29 Jul 2016.

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