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.

Study Overview

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers and participants diagnosed with diabetes or cardiovascular disease will be recruited for this protocol.@@@

Description

  • 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).
  • CAD that is found on CCTA which may be subclinical

EXCLUSION CRITERIA:

  • Pregnant women or 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:

  • Pregnant women and or 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.
  • Subjects with second -or third-degree AV block or sinus node dysfunction will not receive the 13N-ammonia PET/CT imaging unless these patients have a functioning artificial pacemaker.
  • Subjects with any signs or symptoms of acute coronary syndrome, including vasoreactive hypertension with blood pressure exceeding 180/100, any concerning ST segment changes on ECG, or acute chest pain, will not receive the 13N-ammonia PET/CT imaging.

Healthy Volunteers:

INCLUSION CRITERIA:

-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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group 1
Healthy volunteers
Group 2
Subjects diagnosed with diabetes
Group 3
Subjects diagnosed cardiovascular disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
Time Frame: 1 day to 10 years
vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
1 day to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 10 years
Mean Aortic Wall Thickness at the most diseased segment (measured by MRI at FDG PET MRI) --Vessel Wall Area at the most diseased segment (measured by MRI at FDG PET MRI)
1 day to 10 years
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 10 years
to understand the association of each biomarker on vascular disease markers
1 day to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael N Sack, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2013

Primary Completion (Actual)

August 3, 2022

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (Estimated)

September 4, 2013

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

December 8, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

3
Subscribe