Coronary DiseaseNCT00402922
Evaluating the Association Between Pericardial Fat and Coronary Heart Disease - Ancillary to MESA
An observational study of Coronary Disease, run by Wake Forest University.
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. Read more about this study
- Who is it for?
- Ages 45 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Disease
- How many people
- 6,814 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participant in the MESA study
Who may be able to join
- Participant in the MESA study
- Had a baseline and 6-year follow-up CT scan as part of the MESA study
Who cannot join
- Participant did not have a baseline or 6 year follow-up CT in the MESA study
About this study
Official title: Pericardial Fat and Subclinical and Clinical Measures of Coronary Heart Disease - Ancillary to MESA
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.
Read the 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.
- Conditions
- Coronary Disease
- Keywords
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary heart disease events
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionFeb 2008
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jingzhong Ding, PhD, Wake Forest University Health Sciences
- Investigators
- Jingzhong Ding, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402922
- Sponsor's protocol ID
- 1358
- Other IDs
- R01HL085323-01
- Status last verified
- Jan 2017
- First submitted
- 22 Nov 2006
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericardial Fat and Subclinical and Clinical Measures of Coronary Heart Disease - Ancillary to MESA
- ClinicalTrials.gov ID
- NCT00402922
- Acronym / sponsor ID
- 1358
- Conditions
- Coronary Disease
- Keywords
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,814 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participant in the MESA study
Key inclusion criteria (2 listed)
- Participant in the MESA study
- Had a baseline and 6-year follow-up CT scan as part of the MESA study
Key exclusion criteria (1 listed)
- Participant did not have a baseline or 6 year follow-up CT in the MESA study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary heart disease events
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingzhong Ding, MD, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Wake Forest University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary heart disease events (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.