Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT04870827
Status:
TERMINATED
Last Update Posted:
2023-04-06
First Post:
2021-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Chronic Inflammation on Myocardial Perfusion and Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-28', 'size': 309490, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-07T17:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': "PI left NIH, study won't meet it's study aims, so closing study.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2021-05-01', 'studyFirstSubmitQcDate': '2021-05-01', 'lastUpdatePostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Miocardial perfusion in affected vs healthy individuals', 'timeFrame': '1 day', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in MFR in subjects on biologic therapy', 'timeFrame': '1 year', 'description': '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'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'Immune cell', 'Cardiovascular', '13N-ammonia', '11C-acetate', 'Natural History'], 'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_000136-H.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nHeart 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.\n\nObjective:\n\nTo learn if chronic inflammation affects the heart and if taking a biological medicine for chronic inflammation helps improve how the heart works.\n\nEligibility:\n\nAdults ages 18 and older who have moderate to severe psoriasis, and healthy adult volunteers.\n\nDesign:\n\nParticipants will be screened with a medical history. They may take a pregnancy test.\n\nHealthy volunteers will have 1 visit. Those with psoriasis will have a second visit 1 year later.\n\nParticipants 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.\n\nParticipants 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.\n\nParticipants 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.\n\nParticipation for healthy volunteers will last 1-2 days. Participation for those with psoriasis will last 14 months.\n\n...', 'detailedDescription': 'Study Description:\n\nHeart 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.\n\nObjectives:\n\n1. To test the hypothesis that chronic inflammation is a driver of perturbances in myocardial perfusion, function, and tissue composition\n2. To test the hypothesis that biologic treatment for psoriasis will be associated with longitudinal improvement in myocardial perfusion, function, and tissue composition\n3. To characterize immune cell subsets and their association with myocardial perfusion, function, and tissue composition in chronic inflammation\n4. To explore how chronic inflammation may alter myocardial energetics and metabolism\n\nEndpoints:\n\nPrimary outcomes will be:\n\nMyocardial perfusion, as assessed by myocardial flow reserve (MFR), in subjects with moderate to severe psoriasis compared to matched healthy controls.\n\nSecondary outcomes will be:\n\nChange in MFR in subjects with psoriasis on biologic therapy at 1 year follow-up compared to baseline.\n\nDiastolic 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.\n\nChange in diastolic function, myocardial mechanics, myocardial edema and inflammation, and interstitial fibrosis in subjects with psoriasis on biologic therapy at 1 year follow- up\n\nExploratory outcomes will be:\n\nImmune cell subsets by flow cytometry in subjects with 7 moderate to severe psoriasis compared to matched healthy controls\n\nRest and stress left ventricular oxygen consumption (MVO2) in subjects with moderate to severe psoriasis compared to matched healthy controls'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nSubjects of both genders will be considered for inclusion in this study. There will be no racial, ethnic, or gender discrimination.\n\nAffected Subjects:\n\n* 18 years of age or older\n* 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\n\ntreatment for psoriasis\n\nHealthy Controls:\n\nFemales and males 18 years of age or older\n\nEXCLUSION CRITERIA:\n\nAffected Subjects:\n\n* Pregnant or lactating women\n* Subjects with a contraindication to MRI scanning will not receive the CMR assessment.\n\nThese contraindications include subjects with the following devices:\n\ni. Central nervous system aneurysm clips\n\nii. Implanted neural stimulator\n\niii. Implanted cardiac pacemaker or defibrillator\n\niv. Cochlear implant\n\nv. Ocular foreign body (e.g. metal shavings)\n\nvi. Implanted Insulin pump\n\nvii. Metal shrapnel or bullet\n\nviii. Estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73m\\^2 body surface area according to the Modification of Diet in Renal Disease criteria\n\n* History of seizures or taking anti-epileptic medications\n* Inability to provide informed consent\n\nHealthy Controls:\n\n* Diagnosis of inflammatory disease (including psoriasis, psoriatic arthritis, rheumatoid arthritis, lupus, inflammatory bowel disease)\n* Pregnant women and lactating women\n* Subjects with a contraindication to MRI scanning will not receive the CMR assessment.\n\nThese contraindications include subjects with the following devices:\n\nix. Central nervous system aneurysm clips\n\nx. Implanted neural stimulator\n\nxi. Implanted cardiac pacemaker or defibrillator\n\nxii. Cochlear implant\n\nxiii. Ocular foreign body (e.g. metal shavings)\n\nxiv. Implanted Insulin pump\n\nxv. Metal shrapnel or bullet\n\nxvi. Estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73m\\^2 body surface area according to the Modification of Diet in Renal Disease criteria\n\n* History of seizures or taking anti-epileptic medications\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04870827', 'briefTitle': 'Effect of Chronic Inflammation on Myocardial Perfusion and Function', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'The Effect of Chronic Inflammation on Myocardial Perfusion and Function', 'orgStudyIdInfo': {'id': '10000136'}, 'secondaryIdInfos': [{'id': '000136-H'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Affected Subjects', 'description': 'Subjects diagnosed with moderate- severe psoriasis', 'interventionNames': ['Drug: 13N Amonia']}, {'label': 'Healthy Controls', 'description': 'Females and males 18 years of age or older'}], 'interventions': [{'name': '13N Amonia', 'type': 'DRUG', 'description': 'Administered during PET/CT scans', 'armGroupLabels': ['Affected Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Michael N Sack, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '.This is a new requirement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}