Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events
NCT ID: NCT05545618
Last Updated: 2022-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2015-01-01
2022-12-30
Brief Summary
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Detailed Description
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18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including brain neural activity and hematopoiesis.
The 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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CCTA imaging with 18F-FDG-PET/CT assessment
Group of patients with 18F-FDG-PET/CT imaging and Coronary Computed Tomographic Angiography within 90 days
CCTA and 18F-FDG-PET/CT
18F-FDG-PET/CT imaging and comprehensive assessment of coronary plaque with CCTA within 90 days
Interventions
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CCTA and 18F-FDG-PET/CT
18F-FDG-PET/CT imaging and comprehensive assessment of coronary plaque with CCTA within 90 days
Eligibility Criteria
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Inclusion Criteria
* 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;
* 3\) Patients absence of acute or chronic inflammatory or autoimmune disease at the time of imaging;
* 4\) Patients with CCTA performed within 90 days of 18F-FDG PET/CT scan as part of routine clinical practice
* 5\) Patients with diameter stenosis \>30% by CCTA but without coronary revascularization
Exclusion Criteria
* 2\) Coronary lesion with heavy calcification
* 3\) Chronic renal insufficiency (Serum creatinine \>2.0mg/dL)
* 4\) Severe liver dysfunction (aspartate transaminase or alanine transferase \> 5 times of upper normal limit)
* 5\) Pregnancy or potential pregnancy
* 6\) Life expectancy less than 5 year
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Junbo Ge, Professor
Role: STUDY_CHAIR
Fudan University
Locations
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Fuwai Hospital
Beijing, , China
Shanghai Zhongshan Hospital
Shanghai, , China
Shanghai Tenth People's Hospital
Shanghai, , China
Universal Medical Imaging Diagnostic
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Lei Wang
Role: primary
Haidong Cai
Role: primary
Lu Sun
Role: primary
References
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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.
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.
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.
Other Identifiers
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ZS-2022-9-15
Identifier Type: -
Identifier Source: org_study_id
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