Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events

Coronary Artery Disease Clinical Trial

— Blueprint  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545618
• Other study ID #: ZS-2022-9-15
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Neng Dai, MD
• Phone: +8613701997266
• Email: niceday1987[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 in?ammatory 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing
China	Shanghai Tenth People's Hospital	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai
China	Universal Medical Imaging Diagnostic	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum in: Lancet. 2017 Feb 25;389(10071):804. — View 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. — View Citation

Outcome

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