Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: CCTA and 18F-FDG-PET/CT

• Registration Number: NCT05545618
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2015-01-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-15
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-19
• Primary Completion: 2022-10-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CCTA imaging with 18F-FDG-PET/CT assessment	CCTA and 18F-FDG-PET/CT	Group of patients with 18F-FDG-PET/CT imaging and Coronary Computed Tomographic Angiography within 90 days

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	5 years after index imaging	Death from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina.
Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity)	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
Correlation Between amygdalar activity (neurobiological activity) and high-risk plaque	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.
Correlation Between amygdalar activity (neurobiological activity) and coronary inflammation	at the index imaging	Coronary inflammation will be assessed by FAI. Correlation Between amygdalar activity and FAI will be assessed

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death, or nonfatal myocardial infarction	5 years after index imaging	Cardiovascular death, or nonfatal myocardial infarction

Trial Locations

Locations (4)

Universal Medical Imaging Diagnostic; 🇨🇳 Shanghai, China

Fuwai Hospital; 🇨🇳 Beijing, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, China