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CompletedNCT00241787Updated Dec 2, 2015

Progression of Sub-Clinical Atherosclerosis

An observational study in Atherosclerosis, Cardiovascular Diseases and Heart Diseases, sponsored by Tufts Medical Center. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2015-12-02.

Sponsored by Tufts Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,900
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Atherosclerosis
  • Cardiovascular Diseases
  • Heart Diseases
  • Carotid Artery Diseases
03

In context

Atherosclerosis

1,596 studies on the registry are indexed under Atherosclerosis; 262 are open to participants now.

This study's enrollment of 2,900 is above the median of 230 across 581 observational studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

Tufts Medical Center is the lead sponsor of 200 studies on the registry; 29 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 16 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Community based in Framingham MA

Eligibility criteria

No eligibility criteria

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,900 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Cardiovascular Morbidity

    Longitudinal follow-up of community based cohort

    Time frame: Longitudinal follow-up

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00241787
Responsible party
Sponsor
First posted
Oct 19, 2005
Start date
Sep 2005
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Dec 2, 2015

Study contacts

Joseph F Polak, MD, MPH
principal investigator · Tufts Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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