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Links Between Inflammation and Cardiometabolic Diseases

This study is currently recruiting participants.
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Verified May 31, 2017 by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT01934660
First received: August 28, 2013
Last updated: June 30, 2017
Last verified: May 31, 2017
August 28, 2013
June 30, 2017
August 23, 2013
July 15, 2029   (Final data collection date for primary outcome measure)
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 day to 1 year ]
Our primary outcome of interest is vascular inflammation measured by standard uptake valves from PET/ CT and PET/ MRI imaging with FDG. [ Time Frame: data collected at one time point ]
Complete list of historical versions of study NCT01934660 on ClinicalTrials.gov Archive Site
  • 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 1 year ]
  • 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 1 year ]
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: data collected at one time point ]
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Links Between Inflammation and Cardiometabolic Diseases
Inflammatory Characterization of Known or Possible Cardiovascular 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 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.
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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
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  • Diabetes Mellitus
  • Cardiovascular Disease
  • Healthy Volunteer
  • Inflammation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
July 15, 2029
July 15, 2029   (Final data collection date for primary outcome measure)
  • Cardiovascular Disease Eligibility Criteria

INCLUSION CRITERIA:

  • Females and males 18 years of age or older
  • Diagnosis of clinical CAD (including abnormal EKG with a prior infarction pattern, abnormal echo consistent with a wall motion abnormality or a referral note from cardiologist with diagnosis of CAD)
  • CAD that is currently stable (defined by no change in medications for blood pressure, angina or diuretic therapy or in no new CV symptoms over the past month in a patient who has had a primary cardiac event or an abnormal EKG with confirmed wall motion abnormality)
  • CAD which may be associated with chronic stable angina (defined by a clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back, or arm by a physician).

EXCLUSION CRITERIA:

  • For imaging studies, pregnant women.
  • For imaging studies, lactating women
  • For optional adipose biopsy, any subject with known bleeding disorder, current fever or on anti-coagulation.
  • For optional MRI, inability to participate due to 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 nonmelanomatous 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)
  • A BMI >40 kg/m(2) due to PET MRI restrictions
  • Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI.

Diabetes Mellitus Eligibility Criteria

INCLUSION CRITERIA:

  • Females and males 18 years of age or older
  • Diagnosis of type 2 diabetes mellitus (DM), currently stable as defined by no change in antidiabetic medications over the past month and fasting glucose <200

EXCLUSION CRITERIA:

  • For imaging studies, pregnant women
  • For imaging studies, lactating women
  • For optional adipose biopsy, any subject with known bleeding disorder, current fever or on anti-coagulation.
  • For optional MRI, inability to participate due to 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 nonmelanomatous 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)
  • A BMI >40 kg/m(2) due to PET MRI restrictions
  • Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate < 30 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI.

Healthy Volunteers:

INCLUSION CRITERIA:

-Females and males 18 years of age or older without any clinical diagnosis of a chronic health condition 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.
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
Yes
Contact: Andrew G. Keel (240) 276-6545 akeel@cc.nih.gov
Contact: Nehal N Mehta, M.D. (301) 827-0483 mehtann@mail.nih.gov
United States
 
 
NCT01934660
130194
13-H-0194
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National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: Nehal N Mehta, M.D. National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
May 31, 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP