Links Between Inflammation and Cardiometabolic Diseases
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|ClinicalTrials.gov Identifier: NCT01934660|
Recruitment Status : Recruiting
First Posted : September 4, 2013
Last Update Posted : November 19, 2021
- 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 up to six study visits. There will be first visit, then an optional visit 12 months after the first visit.
At the study visits 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.
- Completed a number of questionnaires.
- A body scan called an FDG PET/CT. A substance will be injected through a tube in their arm. They will lie on a special bed that will move in and out of the PET/CT scanner. The PET/CT scanner will take pictures of the body. The scan will last up to 30 minutes.
- Some participants will have other body scans ( FDG PET/MRI). The procedures are similar to the FDG PET/CT scan. These other scans will last about 30 minutes total.
- 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 tests that measures blood pressure and how the blood moves through the body.
- Some participants will have small samples of skin and fat tissue taken.
|Condition or disease|
|Diabetes Mellitus Cardiovascular Disease Healthy Volunteer Inflammation|
|Study Type :||Observational|
|Estimated Enrollment :||480 participants|
|Official Title:||Inflammatory Characterization of Known or Possible Cardiovascular Diseases|
|Actual Study Start Date :||December 2, 2013|
|Estimated Primary Completion Date :||July 15, 2029|
|Estimated Study Completion Date :||July 15, 2029|
Subjects diagnosed with diabetes
Subjects diagnosed cardiovascular disease
- Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG [ Time Frame: 1 day to 4 years ]vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
- 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 day to 4 years ]Mean Aortic Wall Thickness at the most diseased segment (measured by MRI at FDG PET MRI) --Vessel Wall Area at the most diseased segment (measured by MRI at FDG PET MRI)
- 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 day to 4 years ]to understand the association of each biomarker on vascular disease markers
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01934660
|Contact: Tania R Machado||(301) email@example.com|
|Contact: Nehal N Mehta, M.D.||(301) firstname.lastname@example.org|
|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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Nehal N Mehta, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|