- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01934660
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
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Group 1
Healthy volunteers
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Group 2
Subjects diagnosed with diabetes
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Group 3
Subjects diagnosed cardiovascular disease
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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
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vascular inflammation measured by standard uptake values from PET/CT and PET/MRI imaging with FDG
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1 day to 10 years
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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
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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)
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1 day to 10 years
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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
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1 day to 10 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael N Sack, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 130194
- 13-H-0194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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