Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events (Blueprint)
Biological Interconnection of Brain Neurobiological Activity With Atherosclerotic Plaque Vulnerability and the Prognostic Value
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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Beijing, China, 200000
- Recruiting
- Fuwai Hospital
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Contact:
- LEI WANG
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Shanghai, China, 200032
- Recruiting
- Shanghai Zhongshan Hospital
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Shanghai, China
- Recruiting
- Shanghai Tenth People's Hospital
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Contact:
- Haidong Cai
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Shanghai, China
- Recruiting
- Universal Medical Imaging Diagnostic
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Contact:
- Lu Sun
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1) Age: greater than 20
- 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:
- 1) Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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18F-FDG-PET/CT imaging and comprehensive assessment of coronary plaque with CCTA within 90 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity)
Time Frame: at the index imaging
|
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
|
at the index imaging
|
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Correlation Between amygdalar activity (neurobiological activity) and high-risk plaque
Time Frame: at the index imaging
|
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). Correlation Between amygdalar activity and number of high-risk plaque features will be assessed. |
at the index imaging
|
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Correlation Between amygdalar activity (neurobiological activity) and coronary inflammation
Time Frame: at the index imaging
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Coronary inflammation will be assessed by FAI.
Correlation Between amygdalar activity and FAI will be assessed
|
at the index imaging
|
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Major adverse cardiac events
Time Frame: 5 years after index imaging
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Death from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina.
|
5 years after index imaging
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiovascular death, or nonfatal myocardial infarction
Time Frame: 5 years after index imaging
|
Cardiovascular death, or nonfatal myocardial infarction
|
5 years after index imaging
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. Erratum In: Lancet. 2017 Feb 25;389(10071):804. Lancet. 2017 Feb 25;389(10071):804.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZS-2022-9-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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