Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events (Blueprint)

Fudan University

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Diagnostic Test: CCTA and 18F-FDG-PET/CT

Study type

Observational

Funder types

Other

Identifiers

NCT05545618

ZS-2022-9-15

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Age: greater than 20
1. Patients either absence of prior cancer or remission from cancer for at least 1 year prior to imaging and throughout the follow-up period;
1. Patients absence of acute or chronic inﬂammatory or autoimmune disease at the time of imaging;
1. Patients with CCTA performed within 90 days of 18F-FDG PET/CT scan as part of routine clinical practice
1. 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)
1. Coronary lesion with heavy calcification
1. Chronic renal insufficiency (Serum creatinine >2.0mg/dL)
1. Severe liver dysfunction (aspartate transaminase or alanine transferase > 5 times of upper normal limit)
1. Pregnancy or potential pregnancy
1. Life expectancy less than 5 year