Evaluating the Association Between Pericardial Fat and Coronary Heart Disease - Ancillary to MESA

Coronary Disease Clinical Trial

Official title:

Pericardial Fat and Subclinical and Clinical Measures of Coronary Heart Disease - Ancillary to MESA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402922
• Other study ID #: 1358
• Secondary ID: R01HL085323-01
• Status: Completed
• Phase: N/A
• First received: November 22, 2006
• Last updated: January 24, 2017
• Start date: August 2006
• Est. completion date: May 2012

Study information

• Verified date: January 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Coronary heart disease (CHD) is the leading cause of death in the United States. One common risk factor for CHD is obesity. The presence of certain types of fat over others is more commonly associated with the development of CHD. This study will use data from a previous study to examine the association between pericardial fat, a type of fat that surrounds the heart, and CHD.

Description:

CHD is caused by a narrowing of the small blood vessels that supply blood and oxygen to the heart. It usually results from atherosclerosis, a condition in which deposits of fat, cholesterol, and other substances build up along the inner walls of arteries. Risk factors for CHD include tobacco use, high blood pressure, diabetes, and obesity. Visceral fat, the type of fat found in the abdomen and surrounding vital organs, is considered a greater risk factor for CHD than subcutaneous fat, the type of fat found directly below the skin. Pericardial fat, the fat surrounding the heart, is similar to visceral fat, and may be particularly damaging because of its lipotoxicity effects and its ability to trigger inflammation in the coronary arteries. Increased amounts of pericardial fat may therefore accelerate the development of atherosclerosis and CHD. The purpose of this study is to evaluate the relationship between pericardial fat and the development of CHD.

This study will use previously collected data from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) study, a study that examined characteristics of the subclinical, or the early stages of, cardiovascular disease in individuals. There will be no study visits specifically for this study. Participants' study data and computed tomography (CT) scans will be analyzed to determine the following: 1) the presence of pericardial fat and subclinical CHD at study entry; 2) changes in pericardial fat levels and plaque formation; and 3) the presence of pericardial fat and CHD at a 6-year follow-up visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6814
• Est. completion date: May 2012
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 84 Years

Eligibility

Inclusion Criteria:

• Participant in the MESA study

• Had a baseline and 6-year follow-up CT scan as part of the MESA study

Exclusion Criteria:

• Participant did not have a baseline or 6 year follow-up CT in the MESA study

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	National Heart, Lung, and Blood Institute (NHLBI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary heart disease events		6 years