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NCT01934660 · ClinicalTrials.gov registry record
Links Between Inflammation and Cardiometabolic Diseases
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 150
- Enrollment target
NCT01934660: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01934660 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01934660 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study 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.
Primary Outcome
vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
Interventions
- DRUG 13N-amonia
- DRUG Fludeoxyglucose F18
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-12-02 |
What the finished NCT01934660 record still lists
NCT01934660 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which 13N-amonia is the first listed.
NCT01934660 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01934660 about?
NCT01934660 is a clinical study titled "Links Between Inflammation and Cardiometabolic Diseases". 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 af...
What is the current status of trial NCT01934660?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2013-12-02.
What interventions are being tested in trial NCT01934660?
The interventions under investigation include: 13N-amonia (DRUG), Fludeoxyglucose F18 (DRUG).
Who is sponsoring clinical trial NCT01934660?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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