PsoriasisNCT04870827
Effect of Chronic Inflammation on Myocardial Perfusion and Function
An observational study of Psoriasis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- 13N Amonia
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 18 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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 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
Who cannot join
- 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:
- Central nervous system aneurysm clips
- Implanted neural stimulator
Show all 29Show fewer
- Implanted cardiac pacemaker or defibrillator
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Implanted Insulin pump
- Metal shrapnel or bullet
- 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 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:
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Implanted Insulin pump
- Metal shrapnel or bullet
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: The Effect of Chronic Inflammation on Myocardial Perfusion and Function
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.
Read more
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.
...
Read the detailed description
Study 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
Exploratory outcomes will be:
Immune cell subsets by flow cytometry in subjects with 7 moderate to severe psoriasis compared to matched healthy controls
Rest and stress left ventricular oxygen consumption (MVO2) in subjects with moderate to severe psoriasis compared to matched healthy controls
- Conditions
- Psoriasis
- Being tested
- 13N Amonia
- Keywords
- Psoriasis, Immune cell, Cardiovascular, 13N-ammonia, 11C-acetate, Natural History
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13N AmoniaDrug
Administered during PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| Affected Subjects | Subjects diagnosed with moderate- severe psoriasis Receives: Drug: 13N Amonia | |
| Healthy Controls | Females and males 18 years of age or older |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Change in MFR in subjects on biologic therapy
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start7 Jun 2021
- Primary completion6 May 2022
- Study completion18 May 2022
Why it stopped: PI left NIH, study won't meet it's study aims, so closing study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael N Sack, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870827
- Sponsor's protocol ID
- 10000136
- Other IDs
- 000136-H
- Status last verified
- Mar 2023
- First submitted
- 1 May 2021
- Last updated
- 6 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: .This is a new requirement.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chronic Inflammation on Myocardial Perfusion and Function
- ClinicalTrials.gov ID
- NCT04870827
- Acronym / sponsor ID
- 10000136
- Conditions
- Psoriasis
- Keywords
- Psoriasis, Immune cell, Cardiovascular, 13N-ammonia, 11C-acetate, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left NIH, study won't meet it's study aims, so closing study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
Detailed description
Study 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
Exploratory outcomes will be:
Immune cell subsets by flow cytometry in subjects with 7 moderate to severe psoriasis compared to matched healthy controls
Rest and stress left ventricular oxygen consumption (MVO2) in subjects with moderate to severe psoriasis compared to matched healthy controls
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Affected Subjects | – | Drug: 13N AmoniaSubjects diagnosed with moderate- severe psoriasis |
| Healthy Controls | – | –Females and males 18 years of age or older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Subjects of both genders will be considered for inclusion in this study. There will be no racial, ethnic, or gender discrimination.
- 18 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
- Females and males 18 years of age or older
Key exclusion criteria (29 listed)
- Pregnant or lactating women
- Subjects with a contraindication to MRI scanning will not receive the CMR assessment.
- Central nervous system aneurysm clips
- Implanted neural stimulator
- Implanted cardiac pacemaker or defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13N AmoniaAdministered during PET/CT scans | Drug | Affected Subjects |
Primary outcome
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.
1 secondary outcome
Change in MFR in subjects on biologic therapy
Time frame: 1 year
Results and safety
The study was stopped early (reason given: PI left NIH, study won't meet it's study aims, so closing study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. .This is a new requirement.
Related trials for Psoriasis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
RecruitingObservational study
Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis
Osteoporosis, Inflammatory Rheumatism
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
Active, not recruitingObservational study
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Psoriasis, Moderate to Severe Psoriasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael N Sack, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left NIH, study won't meet it's study aims, so closing study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miocardial perfusion in affected vs healthy individuals (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.