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Protocol Details

The Effect of Chronic Inflammation on Myocardial Perfusion and Function

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

000136-H

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Adults who are or may become unable to consent;
Pregnant Women

Special Instructions

Currently Not Provided

Keywords

Psoriasis;
Immune cell;
Cardiovascular;
13N-ammonia;
11C-acetate

Recruitment Keyword(s)

None

Condition(s)

Psoriasis;
Heart Failure

Investigational Drug(s)

13N ammonia
11C acetate

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Wunan Y. Zhou, M.D.
National Heart, Lung and Blood Institute (NHLBI)



Tania R. Machado
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 6D03
10 Center Drive
Bethesda, Maryland 20892
(301) 661-1505
tania.machado@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT04870827

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