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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00402922
Recruitment Status : Completed
First Posted : November 23, 2006
Last Update Posted : January 25, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jingzhong Ding, PhD, Wake Forest University Health Sciences

Tracking Information
First Submitted Date November 22, 2006
First Posted Date November 23, 2006
Last Update Posted Date January 25, 2017
Study Start Date August 2006
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2013)
Coronary heart disease events [ Time Frame: 6 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating the Association Between Pericardial Fat and Coronary Heart Disease - Ancillary to MESA
Official Title Pericardial Fat and Subclinical and Clinical Measures of Coronary Heart Disease - Ancillary to MESA
Brief 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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participant in the MESA study
Condition Coronary Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 22, 2006)
6814
Original Enrollment Same as current
Actual Study Completion Date May 2012
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00402922
Other Study ID Numbers 1358
R01HL085323-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jingzhong Ding, PhD, Wake Forest University Health Sciences
Study Sponsor Wake Forest University
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jingzhong Ding, MD, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date January 2017