Progression of Sub-Clinical Atherosclerosis

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Atherosclerosis; 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
• Enrollment (Actual): 2900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community based in Framingham MA

Description

No eligibility criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Morbidity	Longitudinal follow-up of community based cohort	Longitudinal follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: October 17, 2005
• First Submitted That Met QC Criteria: October 17, 2005
• First Posted (Estimate): October 19, 2005

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: 1314; R01HL081352 (U.S. NIH Grant/Contract)