Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-31 @ 11:00 PM
Study NCT ID:
NCT01934660
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2013-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Links Between Inflammation and Cardiometabolic Diseases
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
Inflammatory Characterization of Known or Possible Cardiovascular Diseases
Status:
COMPLETED
Status Verified Date:
2025-09-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
\- 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.
Objectives:
\- To learn if there are links between inflammation and cardiometabolic diseases.
Eligibility:
* Adults 18 years of age or older with heart disease or diabetes.
* Healthy volunteers 18 years of age or older.
Design:
* 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.
\- 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.
Objectives:
\- To learn if there are links between inflammation and cardiometabolic diseases.
Eligibility:
* Adults 18 years of age or older with heart disease or diabetes.
* Healthy volunteers 18 years of age or older.
Design:
* 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.
Detailed Description:
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 13-H-0194 | None | None | View |