Links Between Inflammation and Cardiometabolic Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by National Institutes of Health Clinical Center (CC)
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: July 9, 2016
Last verified: July 2016
  Purpose

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.

Condition
Diabetes Mellitus
Cardiovascular Disease
Healthy Volunteer
Inflammation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Inflammatory Characterization of Known or Possible Cardiovascular Diseases

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: August 2013
Estimated Study Completion Date: July 2029
Estimated Primary Completion Date: July 2022 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01934660

Contacts
Contact: Dorothy J Tripodi, R.N. (301) 496-3431 tripodid@nhlbi.nih.gov
Contact: Nehal N Mehta, M.D. (301) 827-0483 mehtann@mail.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Nehal N Mehta, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01934660     History of Changes
Other Study ID Numbers: 130194  13-H-0194 
Study First Received: August 28, 2013
Last Updated: July 9, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cardiovascular Disease
Diabetes Mellitus
Inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Inflammation
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 21, 2016