Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT01778569
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2013-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03-20', 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2013-01-26', 'studyFirstSubmitQcDate': '2013-01-26', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Our primary outcome of interest is vascular inflammation measured by standard uptake values from PET-CT imaging with FDG.', 'timeFrame': '4-6 years', 'description': 'vascular inflammation measured by standard uptake values from PET-CT imaging with FDG.'}], 'secondaryOutcomes': [{'measure': 'Mean Aortic Wall Thickness', 'timeFrame': '4-6 years'}, {'measure': 'Coronary Artery Calcium Score', 'timeFrame': '4-6 years'}, {'measure': 'HDL function', 'timeFrame': '4-6 years'}, {'measure': 'lipoprotein particle size and number', 'timeFrame': '4-6 years'}, {'measure': 'immune, metabolic & inflammation measure', 'timeFrame': '4-6 years'}, {'measure': 'Myocardial Flow Reserve (MFR)', 'timeFrame': '4-6 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Imaging', 'Cardiovascular Risk Factors', 'Inflammation', 'Lipoproteins', 'Metabolic Dysfunction', 'Natural History'], 'conditions': ['Metabolic Disease', 'Cardiovascular Disease', 'Inflammation', 'Psoriasis']}, 'referencesModule': {'references': [{'pmid': '37982276', 'type': 'DERIVED', 'citation': "Florida EM, Li H, Hong CG, Ongstad EL, Gaddipati R, Sitaula S, Varma V, Parel PM, O'Hagan R, Chen MY, Teague HL, Playford MP, Karathanasis SK, Collen A, Mehta NN, Remaley AT, Sorokin AV. Relationship of Soluble Lectin-Like Low-Density Lipoprotein Receptor-1 (sLOX-1) With Inflammation and Coronary Plaque Progression in Psoriasis. J Am Heart Assoc. 2023 Nov 21;12(22):e031227. doi: 10.1161/JAHA.123.031227. Epub 2023 Nov 20."}, {'pmid': '37106374', 'type': 'DERIVED', 'citation': "Sorokin AV, Patel N, Li H, Hong CG, Sampson M, O'Hagan R, Florida EM, Teague HL, Playford MP, Chen MY, Mehta NN, Remaley AT. Estimated sdLDL-C for predicting high-risk coronary plaque features in psoriasis: a prospective observational study. Lipids Health Dis. 2023 Apr 27;22(1):55. doi: 10.1186/s12944-023-01819-x."}, {'pmid': '37088280', 'type': 'DERIVED', 'citation': "Teague HL, Li H, Berg AR, Hong C, Petrole RF, O'Hagan R, Florida EM, Keel A, Rodante J, Kapoor P, Gonzalez-Cantero A, Sorokin AV, Joshi A, Patel N, Gelfand JM, Playford MP, Mehta NN. The Relationship between Circulating APOA-1 and Atherosclerosis Initiation and Progression in Psoriasis. J Invest Dermatol. 2023 Oct;143(10):1947-1954.e4. doi: 10.1016/j.jid.2023.01.044. Epub 2023 Apr 22."}, {'pmid': '33104056', 'type': 'DERIVED', 'citation': 'Sajja A, Abdelrahman KM, Reddy AS, Dey AK, Uceda DE, Lateef SS, Sorokin AV, Teague HL, Chung J, Rivers J, Joshi AA, Elnabawi YA, Goyal A, Rodante JA, Keel A, Alvarez JE, Lockshin B, Prussick R, Siegel E, Playford MP, Chen MY, Bluemke DA, Gelfand JM, Mehta NN. Chronic inflammation in psoriasis promotes visceral adiposity associated with noncalcified coronary burden over time. JCI Insight. 2020 Nov 19;5(22):e142534. doi: 10.1172/jci.insight.142534.'}, {'pmid': '26188212', 'type': 'DERIVED', 'citation': 'Salahuddin T, Natarajan B, Playford MP, Joshi AA, Teague H, Masmoudi Y, Selwaness M, Chen MY, Bluemke DA, Mehta NN. Cholesterol efflux capacity in humans with psoriasis is inversely related to non-calcified burden of coronary atherosclerosis. Eur Heart J. 2015 Oct 14;36(39):2662-5. doi: 10.1093/eurheartj/ehv339. Epub 2015 Jul 18.'}, {'pmid': '25224267', 'type': 'DERIVED', 'citation': 'Rose S, Stansky E, Dagur PK, Samsel L, Weiner E, Jahanshad A, Doveikis J, Naik HB, Playford MP, McCoy JP, Mehta NN. Characterization of immune cells in psoriatic adipose tissue. J Transl Med. 2014 Sep 16;12:258. doi: 10.1186/s12967-014-0258-2.'}, {'pmid': '25058615', 'type': 'DERIVED', 'citation': 'Mehta NN, Dagur PK, Rose SM, Naik HB, Stansky E, Doveikis J, Biancotto A, Playford MP, Philip McCoy J Jr. IL-17A production in human psoriatic blood and lesions by CD146+ T cells. J Invest Dermatol. 2015 Jan;135(1):311-314. doi: 10.1038/jid.2014.317. Epub 2014 Jul 24. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2013-H-0065.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\n\\- Cardiometabolic diseases are medical disorders that can occur together and affect the heart. They increase the risk of developing heart disease and diabetes. One disorder, psoriasis, is an inflammation that mostly affects the skin but can affect the entire body. Another disorder, atherosclerosis, is a process in which cholesterol is gradually deposited on the wall of arteries. This causes arteries to harden and become less flexible. Many cells that cause psoriasis also cause atherosclerosis. Researchers want to look at the relationship between cardiometabolic diseases and psoriasis.\n\nObjectives:\n\n\\- To study the relationship between psoriasis and cardiometabolic diseases.\n\nEligibility:\n\n\\- Individuals at least 18 years of age who have psoriasis.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history.\n* Participants will have up to seven outpatient visits over the 4 years. The first visit will be a screening visit. Visits 2 will be12 months after visit 1. Visits 3, 4, and 5, will be scheduled yearly for the next 3 years. If participants have a psoriasis flare with more severe symptoms, they may have an extra visit. Those who leave the study early will have a final visit with the full series of tests.\n* At visits 1, 2,and 5, and any flare visits, participants will have a physical exam and medical history. They will provide blood and urine samples, as well as optional tissue biopsies. They will also have heart function tests. Imaging studies, as well as optional photographs of affected areas, will be performed. These tests will also be performed at the final visit.\n* At visits 3 and 4, participants will have a physical exam and medical history. They will also provide blood and urine samples, and have heart function tests.', 'detailedDescription': 'Over the past two decades, inflammation has been identified as an important pathogenic process in cardiometabolic diseases (CMD) such atherosclerotic cardiovascular disease (CVD), dyslipidemia, insulin resistance, diabetes and obesity. However, mechanistic links between inflammation and these disease states in humans remain poorly understood. In this study, we propose to utilize psoriasis, a common, chronic inflammatory T-cell skin disease associated with increased CVD and CMD as a model to understand the effect of chronic inflammation on these diseases states. We will conduct a prospective cohort study to understand the effect of chronic inflammation on vascular and metabolic disease at the NIH Clinical Center. Furthermore, we will initiate a large scale collection of blood and skin from extramural sites to facilitate discovery of pathways involved in inflammatory modulation of CVD and CMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient with a diagnosis of chronic plaque psoriasis, psoriatic arthritis, or pustular psoriasis will be considered for this protocol.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA\n* 18 years of age or older\n* Diagnosed with psoriasis clinically confirmed by provider, consisting of typical skin findings and associated findings of systemic disease of joints, nails and hair)\n\nEXCLUSION CRITERIA\n\n* For skin and adipose biopsy, any subject with known bleeding disorder, current fever or on anticoagulation.\n* Pregnant women and lactating women, may not undergo any study procedures until they are no longer pregnant or breast feeding.\n* Subjects with a contraindication to MRI scanning will not receive the optional PET/MRI. These contraindications include subjects with the following devices:\n\n * Central nervous system aneurysm clips\n * Implanted neural stimulator\n * Implanted cardiac pacemaker or defibrillator\n * Cochlear implant\n * Ocular foreign body (e.g. metal shavings)\n * Implanted Insulin pump\n * Metal shrapnel or bullet\n* Subjects with a BMI \\>45 will also not receive the PET MRI.\n* Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate \\< 30 mL/min/1.73m\\^2 body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI.'}, 'identificationModule': {'nctId': 'NCT01778569', 'briefTitle': 'The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Human Translational Studies of Inflammation and Cardiometabolic Diseases: The Psoriasis, Atherosclerosis and Cardiometabolic Disease (PACI) Initiative', 'orgStudyIdInfo': {'id': '130065'}, 'secondaryIdInfos': [{'id': '13-H-0065'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patient with a diagnosis of chronic plaque psoriasis, psoriatic arthritis, or pustular psoriasis'}]}, '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}