Clinical trial NCT05545618: Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events
Official title: Biological Interconnection of Brain Neurobiological Activity With Atherosclerotic Plaque Vulnerability and the Prognostic Value
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent clinically indicated 18F-FDG PET/CT and with CCTA performed within 90 days of 18F-FDG PET/CT scan will be included.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity)
timeFrame: at the index imaging
measure: Correlation Between amygdalar activity (neurobiological activity) and high-risk plaque
timeFrame: at the index imaging
measure: Correlation Between amygdalar activity (neurobiological activity) and coronary inflammation
timeFrame: at the index imaging
measure: Major adverse cardiac events
timeFrame: 5 years after index imaging
Secondary outcomes:
measure: Cardiovascular death, or nonfatal myocardial infarction
timeFrame: 5 years after index imaging
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: Universal Medical Imaging Diagnostic
Study officials:
affiliation: Fudan University
name: Junbo Ge, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.