Progression of Sub-Clinical Atherosclerosis

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241787
• Other study ID #: 1314
• Secondary ID: R01HL081352
• Status: Completed
• Phase: N/A
• First received: October 17, 2005
• Last updated: November 30, 2015
• Start date: September 2005
• Est. completion date: August 2011

Study information

• Verified date: November 2015
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2900
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years
• Eligibility: No eligibility criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular Morbidity	Longitudinal follow-up of community based cohort	Longitudinal follow-up	No