Inflammatory Characterization of Known or Possible Cardiovascular Diseases

  • STATUS
    Recruiting
Updated on 23 November 2020
diabetes
heart disease
fats

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.

Please visit our Patient Recruitment Page for more information.

 

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).

 

Please visit our Patient Recruitment Page for more information.

Details
Condition Cardiovascular Disease
Clinical Study IdentifierTX218175
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Cardiovascular Disease?
Females and males 18 years of age or older without any clinical diagnosis of a chronic health condition that is knownto accelerate vascular disease beyond traditional risk factors including lung disease or active infection

Exclusion Criteria

For imaging studies, pregnant women
For imaging studies, lactating women
For optional MRI, inability to participate due to in optional MRI metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan
Any solid organ or liquid tumor within the past five years, with the exception of non melanomatous skin cancer
Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP)
Clinical diagnosis of diabetes or cardiovascular disease
Fasting glucose >125
LDL>200
LFT s 3 times normal limit
eGFR<60
Subjects with severe renal excretory dysfunction will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI
A BMI >40 kg/m(2) due to PET MRI restrictions
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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