Effect of Chronic Inflammation on Myocardial Perfusion and Function

NCT04870827 | Terminated FDA Drug

• 2 other identifiers: 10000136000136-H
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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. ...

Conditions

Psoriasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Miocardial perfusion in affected vs healthy individuals

  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.

  1 day

Secondary Outcomes (1)

• Change in MFR in subjects on biologic therapy

  1 year

Study Arms (2)

Affected Subjects

Subjects diagnosed with moderate- severe psoriasis

Drug: 13N Amonia

Healthy Controls

Females and males 18 years of age or older

Interventions

13N Amonia DRUG

Administered during PET/CT scans

Affected Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Affected Subjects:
• years of age or older
• Diagnosed with moderate-severe psoriasis clinically confirmed by a 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael N Sack, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 4, 2021
• Study Start: June 7, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 18, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-03

Locations

US (1)