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Effect of Chronic Inflammation on Myocardial Perfusion and Function

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ClinicalTrials.gov Identifier: NCT04870827
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:

Background:

Heart failure (HF) is a public health burden. Studies have shown a link between inflammation, myocardial dysfunction, and HF. Researchers want to use psoriasis as a disease model of chronic inflammation to further study the link between inflammation and myocardial dysfunction.

Objective:

To learn if chronic inflammation affects the heart and if taking a biological medicine for chronic inflammation helps improve how the heart works.

Eligibility:

Adults ages 18 and older who have moderate to severe psoriasis, and healthy adult volunteers.

Design:

Participants will be screened with a medical history. They may take a pregnancy test.

Healthy volunteers will have 1 visit. Those with psoriasis will have a second visit 1 year later.

Participants may give blood samples. They may have a heart function test. They may have a heart imaging test, and may get a contrast agent. If so, it will be injected into a vein.

Participants may have positron emission tomography/computed tomography tests. They will lie on their back on a padded table with their arms straight overhead. They may get radioactive drugs through an intravenous (IV) catheter. They will get stress medicines through the IV. These drugs mimic exercise and increase blood flow through the heart.

Participants may have cardiac magnetic resonance imaging. The scanner is a large tube. Participants will lie on a table that slides in and out of the tube. They will get gadolinium contrast in a vein to improve the pictures. They may get stress medicines. Coils will be used to help make the pictures.

Participation for healthy volunteers will last 1-2 days. Participation for those with psoriasis will last 14 months.

...


Condition or disease
Psoriasis Heart Failure

Detailed Description:

Heart failure (HF) remains a significant public health burden despite expanding and improving treatment options. Clinical and pre-clinical studies have demonstrated compelling relationships between inflammation, myocardial dysfunction, HF and adverse clinical outcomes. In this study to be conducted at the NIH Clinical Center, we propose to utilize psoriasis as a disease model to study how chronic inflammation effects myocardial perfusion, measured by myocardial flow reserve (MFR) on positron emission tomography (PET) and cardiac MRI (CMR), and myocardial function and tissue composition measured by multi-modality cardiovascular imaging.

Objectives:

To test the hypothesis that chronic inflammation is a driver of perturbances in myocardial perfusion, function and tissue composition

To test the hypothesis that biologic treatment for psoriasis will be associated with longitudinal improvement in myocardial perfusion, function and tissue composition

To characterize immune cell subsets and their association with myocardial perfusion, function and tissue composition in chronic inflammation

To explore how chronic inflammation may alter myocardial energetics and metabolism

Endpoints:

Primary outcomes will be:

Myocardial perfusion, as assessed by myocardial flow reserve (MFR), in subjects with moderate to severe psoriasis compared to matched healthy controls.

Secondary outcomes will be:

Change in MFR in subjects with psoriasis on biologic therapy at 1 year follow-up compared to baseline.

Diastolic function (on echocardiogram), myocardial mechanics (on echocardiogram and CMR), myocardial edema and inflammation, and interstitial fibrosis (on CMR) in subjects with moderate to severe psoriasis compared to matched healthy controls.

Change in diastolic function, myocardial mechanics, myocardial edema and inflammation, and interstitial fibrosis in subjects with psoriasis on biologic therapy at 1 year follow- up

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Study Type : Observational
Estimated Enrollment : 168 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Chronic Inflammation on Myocardial Perfusion and Function
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : July 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
Affected Subjects
Subjects diagnosed with moderate- severe psoriasis
Healthy Controls
Females and males 18 years of age or older



Primary Outcome Measures :
  1. Miocardial perfusion in affected vs healthy individuals [ Time Frame: 1 day ]
    Primary outcome will be: Myocardial perfusion, as assessed by myocardial flow reserve (MFR), in subjects with moderate to severe psoriasis compared to matched healthy controls.


Secondary Outcome Measures :
  1. Change in MFR in subjects on biologic therapy [ Time Frame: 1 year ]
    Change in MFR in subjects with psoriasis on biologic therapy at 1 year follow-up compared to baseline. 2.Diastolic function (on echocardiogram), myocardial mechanics (on echocardiogram and CMR), myocardial edema and inflammation, and interstitial fibrosis (on CMR) in subjects with moderate to severe psoriasis compared to matched healthy controls. 3.Change in diastolic function, myocardial mechanics, myocardial edema and inflammation, and interstitial fibrosis in subjects with psoriasis on biologic therapy at 1 year follow- up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This is a primary clinical protocol. Affected subjects are defined as patients whose psoriasis is diagnosed clinically by a referring dermatologist or rheumatologist, some of which are planning to start biologic therapy for psoriasis. Healthy controls are also enrolled from the community.
Criteria
  • INCLUSION CRITERIA:

Subjects of both genders will be considered for inclusion in this study. There will be no racial, ethnic, or gender discrimination.

Affected Subjects:

  • 18 years of age or older
  • Diagnosed with moderate-severe psoriasis clinically confirmed by licensed physician, or advanced practitioner consisting of typical skin findings and/or associated findings of systemic disease of joints, nails and hair and may be scheduled to initiate biologic treatment for psoriasis

Healthy Controls:

Females and males 18 years of age or older

EXCLUSION CRITERIA:

Affected Subjects:

  • Pregnant or lactating women
  • Subjects with a contraindication to MRI scanning will not receive the CMR assessment.

These contraindications include subjects with the following devices:

i. Central nervous system aneurysm clips

ii. Implanted neural stimulator

iii. Implanted cardiac pacemaker or defibrillator

iv. Cochlear implant

v. Ocular foreign body (e.g. metal shavings)

vi. Implanted Insulin pump

vii. Metal shrapnel or bullet

viii. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 body surface area according to the Modification of Diet in Renal Disease criteria

  • History of seizures or taking anti-epileptic medications
  • Inability to provide informed consent

Healthy Controls:

  • Diagnosis of an inflammatory disease (including psoriasis, psoriatic arthritis, rheumatoid arthritis, lupus, inflammatory bowel disease)
  • Pregnant women and lactating women
  • Subjects with a contraindication to MRI scanning will not receive the CMR assessment.

These contraindications include subjects with the following devices:

ix. Central nervous system aneurysm clips

x. Implanted neural stimulator

xi. Implanted cardiac pacemaker or defibrillator

xii. Cochlear implant

xiii. Ocular foreign body (e.g. metal shavings)

xiv. Implanted Insulin pump

xv. Metal shrapnel or bullet

xvi. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 body surface area according to the Modification of Diet in Renal Disease criteria

  • History of seizures or taking anti-epileptic medications
  • Inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04870827


Contacts
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Contact: Tania R Machado (301) 661-1505 tania.machado@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Wunan Y Zhou, M.D. National Heart, Lung, and Blood Institute (NHLBI)
Additional Information:
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Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT04870827    
Other Study ID Numbers: 10000136
000136-H
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: September 1, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Psoriasis
Immune cell
Cardiovascular
13N-ammonia
11C-acetate
Natural History
Additional relevant MeSH terms:
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Psoriasis
Inflammation
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases