Links Between Inflammation and Cardiometabolic Diseases
- Cardiometabolic diseases are a combination of medical disorders that, when they occur together, increase the risk of heart disease and diabetes. Researchers want to learn if there is a relationship between these diseases and inflammation (redness, swelling, and pain). Inflammation affects the entire body. Researchers will study this relationship in people with heart disease and diabetes, and compare it to healthy people.
- To learn if there are links between inflammation and cardiometabolic diseases.
- Adults 18 years of age or older with heart disease or diabetes.
- Healthy volunteers 18 years of age or older.
- Participants will have one study visit. At this visit they will have:
- Blood taken with a needle in their arm.
- An electrocardiogram. Small patches are stuck to the chest and limbs. A machine measures electrical signals of the heart.
- Some participants will also have a CT scan of their heart. A substance will be injected through a tube in their arm. They will lie on a table in a large, donut-shaped machine. An X-ray tube will move around their body, taking many pictures. This procedure can last up to 2 hours.
- Some participants will have other body scans (PET and MRI). The procedures are similar to the CT scan. These other scans will last about 30 minutes total.
- Some participants will have small samples of skin and fat tissue taken.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Inflammatory Characterization of Known or Possible Cardiovascular Diseases|
- Our primary outcome of interest is vascular inflammation measured by standard uptake valves from PET/ CT and PET/ MRI imaging with FDG. [ Time Frame: 1-3 days ] [ Designated as safety issue: No ]
- Our secondary outcomes are mean aortic wall thickness at the most diseased segment on FDG PET/ CT and vessel wall area on MRI at the most diseased segment, and we will perform analyses using a model including the same variables as above. [ Time Frame: 1-3 days ] [ Designated as safety issue: No ]
- As a tertiary analysis, we will add novel biomarkers to the above models including HDL efflux, HOMA-IR and inflammatory mediators to understand the association of each biomarker on vascular disease markers. [ Time Frame: 1-3 days ] [ Designated as safety issue: No ]
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||July 2025|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Over the past two decades, the number of subjects with cardiometabolic diseases (CMD) such as atherosclerotic cardiovascular disease (CVD), dyslipidemia, insulin resistance and diabetes have been rising. Characterizing these disease states reveals that inflammation is a common feature of CMD; however, mechanistic links between inflammation and these disease states in humans remain poorly understood. In this protocol, we aim to characterize inflammation within the blood vessels, blood, fat and skin in diabetes and coronary artery disease compared to those without disease. We hypothesize that diabetes and coronary disease will be systemic inflammatory states and will provide an important frame of reference for parameters found on novel imaging techniques in another ongoing protocol trying to understand how skin inflammation affects risk for CMD and CVD (13-H-0065).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01934660
|Contact: Dorothy J Tripodi, R.N.||(301) firstname.lastname@example.org|
|Contact: Nehal N Mehta, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Nehal N Mehta, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|