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Progression of Sub-Clinical Atherosclerosis

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ClinicalTrials.gov Identifier: NCT00241787
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
To determine the rate of progression of sub-clinical cardiovascular disease as measured in carotid intimal medial thickness over a period of 8 to 10 years.

Condition or disease
Atherosclerosis Cardiovascular Diseases Heart Diseases Carotid Artery Diseases

Detailed Description:

BACKGROUND:

Strong associations exist between cardiovascular events and increased carotid artery wall intima-media thickness (IMT) as measured non-invasively by carotid ultrasound. Carotid IMT is accepted as a surrogate marker of sub-clinical cardiovascular disease.The study will determine the rate of progression of sub-clinical cardiovascular disease (change in IMT) over a period of 8 to 10 years.

DESIGN NARRATIVE:

The study will determine the rate of progression of sub-clinical cardiovascular disease (change in intimal medial thickness {IMT}) over a period of 8 to 10 years. Imaging and IMT measurements of approximately 2800 to 3000 members of the Framingham Offspring cohort having had baseline IMT measurements at their 1995-98 clinic visit will be repeated in 2005-2007. The principal aims of the project are to study the primary hypotheses that: 1. Interim exposure to traditional cardiovascular risk factors measured over 50 years is positively associated with the progression rate of carotid IMT. 2. Baseline carotid IMT and cumulative exposure to cardiovascular risk factors 20 years before the baseline visit are a better predictor of progression of sub-clinical disease after 8 to 10 years than the interim exposure to risk factors. 3. Novel risk factors such as C-reactive protein and homocysteine affect progression of carotid atherosclerosis more than traditional risk factors. This study will add a phenotypic marker of site-specific change in sub-clinical cardiovascular disease to the Framingham Study database. This complements ongoing research on the progression of sub-clinical cardiovascular disease and its associations with family history of premature cardiovascular events and genomic markers


Study Type : Observational
Actual Enrollment : 2900 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources




Primary Outcome Measures :
  1. Cardiovascular Morbidity [ Time Frame: Longitudinal follow-up ]
    Longitudinal follow-up of community based cohort



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community based in Framingham MA
Criteria
No eligibility criteria

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): NCT00241787


Sponsors and Collaborators
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Joseph F Polak, MD, MPH Tufts Medical Center

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00241787     History of Changes
Other Study ID Numbers: 1314
R01HL081352 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases