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Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events

Biological Interconnection of Brain Neurobiological Activity With Atherosclerotic Plaque Vulnerability and the Prognostic Value

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05545618
Acronym
Blueprint
Enrollment
300
Registered
2022-09-19
Start date
2015-01-01
Completion date
2022-12-30
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTCCTA and 18F-FDG-PET/CT

18F-FDG-PET/CT imaging and comprehensive assessment of coronary plaque with CCTA within 90 days

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity)at the index imagingAmygdalar 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
Correlation Between amygdalar activity (neurobiological activity) and high-risk plaqueat the index imagingHigh-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.
Correlation Between amygdalar activity (neurobiological activity) and coronary inflammationat the index imagingCoronary inflammation will be assessed by FAI. Correlation Between amygdalar activity and FAI will be assessed
Major adverse cardiac events5 years after index imagingDeath from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina.

Secondary

MeasureTime frameDescription
Cardiovascular death, or nonfatal myocardial infarction5 years after index imagingCardiovascular death, or nonfatal myocardial infarction

Countries

China

Contacts

Primary ContactNeng Dai, MD
niceday1987@hotmail.com+8613701997266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026