Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT05545618
Status:
UNKNOWN
Last Update Posted:
2022-09-19
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity)', 'timeFrame': 'at the index imaging', 'description': 'Amygdalar target-to-background ratio (TBR) = Amygdalar standardized uptake value (SUV) / Temporal lobe SUV Bone marrow TBR = Bone marrow SUV / Jugular vein SUV Correlation between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity) will be assessed'}, {'measure': 'Correlation Between amygdalar activity (neurobiological activity) and high-risk plaque', 'timeFrame': 'at the index imaging', 'description': 'High-risk plaque features will be assessed by CCTA including positive remodeling (PR, defined as lesion diameter/reference diameter ≥1.1), low attenuation plaque (LAP, defined as a focal central area of plaque with an attenuation density of \\<30 Hounsfield Units), spotty calcification (SC, defined as focal calcification within the coronary artery wall \\<3mm in maximum diameter), and the "napkin ring" sign (defined as a central area of low attenuation plaque that had a peripheral rim of high attenuation).\n\nCorrelation Between amygdalar activity and number of high-risk plaque features will be assessed.'}, {'measure': 'Correlation Between amygdalar activity (neurobiological activity) and coronary inflammation', 'timeFrame': 'at the index imaging', 'description': 'Coronary inflammation will be assessed by FAI. Correlation Between amygdalar activity and FAI will be assessed'}, {'measure': 'Major adverse cardiac events', 'timeFrame': '5 years after index imaging', 'description': 'Death from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular death, or nonfatal myocardial infarction', 'timeFrame': '5 years after index imaging', 'description': 'Cardiovascular death, or nonfatal myocardial infarction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '28088338', 'type': 'BACKGROUND', 'citation': 'Tawakol A, Ishai A, Takx RA, Figueroa AL, Ali A, Kaiser Y, Truong QA, Solomon CJ, Calcagno C, Mani V, Tang CY, Mulder WJ, Murrough JW, Hoffmann U, Nahrendorf M, Shin LM, Fayad ZA, Pitman RK. Relation between resting amygdalar activity and cardiovascular events: a longitudinal and cohort study. Lancet. 2017 Feb 25;389(10071):834-845. doi: 10.1016/S0140-6736(16)31714-7. Epub 2017 Jan 12.'}, {'pmid': '31248544', 'type': 'BACKGROUND', 'citation': 'Tawakol A, Osborne MT, Wang Y, Hammed B, Tung B, Patrich T, Oberfeld B, Ishai A, Shin LM, Nahrendorf M, Warner ET, Wasfy J, Fayad ZA, Koenen K, Ridker PM, Pitman RK, Armstrong KA. Stress-Associated Neurobiological Pathway Linking Socioeconomic Disparities to Cardiovascular Disease. J Am Coll Cardiol. 2019 Jul 2;73(25):3243-3255. doi: 10.1016/j.jacc.2019.04.042.'}, {'pmid': '38377235', 'type': 'DERIVED', 'citation': 'Dai N, Tang X, Weng X, Cai H, Zhuang J, Yang G, Zhou F, Wu P, Liu B, Duan S, Yu Y, Guo W, Ju Z, Zhang L, Wang Z, Wang Y, Lu B, Shi H, Qian J, Ge J. Sex Differences in Coronary Inflammation and Atherosclerosis Phenotypes in Response to Imaging Marker of Stress-Related Neural Activity. Circ Cardiovasc Imaging. 2024 Feb;17(2):e016057. doi: 10.1161/CIRCIMAGING.123.016057. Epub 2024 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The effect of brain-heart interaction remains unclear. The study aims to investigate the biological interconnection between brain neural activity and coronary plaque morphological and inflammatory features, as well as their connection with clinical outcomes.', 'detailedDescription': 'Brain neural activity assessed by resting amygdalar activity (AmygA) can predict cardiovascular events. However, its biological interconnection with plaque vulnerability i is not fully understood. Coronary computed tomographic angiography (CCTA) is a non-invasive technique that enables comprehensive assessment of morphological characteristics of coronary atheroma and estimates the level of plaque instability. Recently, perivascular fat attenuation index (FAI) enables assessment of coronary inflammation by analyzing changes of perivascular adipose tissue attenuation in CCTA.\n\n18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including brain neural activity and hematopoiesis.\n\nThe present study aims to use ¹⁸F-FDG PET/CT to assess the AmygA, and to investigate its association with CCTA assessed plaque morphological and inflammatory features as well as their ability in predicting future cardiovascular disease events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent clinically indicated 18F-FDG PET/CT and with CCTA performed within 90 days of 18F-FDG PET/CT scan will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Age: greater than 20\n* 2\\) Patients either absence of prior cancer or remission from cancer for at least 1 year prior to imaging and throughout the follow-up period;\n* 3\\) Patients absence of acute or chronic inflammatory or autoimmune disease at the time of imaging;\n* 4\\) Patients with CCTA performed within 90 days of 18F-FDG PET/CT scan as part of routine clinical practice\n* 5\\) Patients with diameter stenosis \\>30% by CCTA but without coronary revascularization\n\nExclusion Criteria:\n\n* 1\\) Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)\n* 2\\) Coronary lesion with heavy calcification\n* 3\\) Chronic renal insufficiency (Serum creatinine \\>2.0mg/dL)\n* 4\\) Severe liver dysfunction (aspartate transaminase or alanine transferase \\> 5 times of upper normal limit)\n* 5\\) Pregnancy or potential pregnancy\n* 6\\) Life expectancy less than 5 year'}, 'identificationModule': {'nctId': 'NCT05545618', 'acronym': 'Blueprint', 'briefTitle': 'Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Biological Interconnection of Brain Neurobiological Activity With Atherosclerotic Plaque Vulnerability and the Prognostic Value', 'orgStudyIdInfo': {'id': 'ZS-2022-9-15'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CCTA imaging with 18F-FDG-PET/CT assessment', 'description': 'Group of patients with 18F-FDG-PET/CT imaging and Coronary Computed Tomographic Angiography within 90 days', 'interventionNames': ['Diagnostic Test: CCTA and 18F-FDG-PET/CT']}], 'interventions': [{'name': 'CCTA and 18F-FDG-PET/CT', 'type': 'DIAGNOSTIC_TEST', 'description': '18F-FDG-PET/CT imaging and comprehensive assessment of coronary plaque with CCTA within 90 days', 'armGroupLabels': ['CCTA imaging with 18F-FDG-PET/CT assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lei Wang', 'role': 'CONTACT'}], 'facility': 'Fuwai Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Neng Dai, MD', 'role': 'CONTACT', 'email': 'niceday1987@hotmail.com', 'phone': '+8613701997266'}], 'facility': 'Shanghai Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haidong Cai', 'role': 'CONTACT'}], 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Sun', 'role': 'CONTACT'}], 'facility': 'Universal Medical Imaging Diagnostic', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Neng Dai, MD', 'role': 'CONTACT', 'email': 'niceday1987@hotmail.com', 'phone': '+8613701997266'}], 'overallOfficials': [{'name': 'Junbo Ge, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}