Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events

NCT05545618 | Unknown

• 1 other identifier: ZS-2022-9-15
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Major adverse cardiac events

  Death from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina.

  5 years after index imaging

Secondary Outcomes (1)

• Cardiovascular death, or nonfatal myocardial infarction

  5 years after index imaging

Study Arms (1)

CCTA imaging with 18F-FDG-PET/CT assessment

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

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

Interventions

CCTA and 18F-FDG-PET/CT DIAGNOSTIC_TEST

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

CCTA imaging with 18F-FDG-PET/CT assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \) Age: greater than 20
• \) Patients either absence of prior cancer or remission from cancer for at least 1 year prior to imaging and throughout the follow-up period;
• \) Patients absence of acute or chronic inflammatory or autoimmune disease at the time of imaging;
• \) Patients with CCTA performed within 90 days of 18F-FDG PET/CT scan as part of routine clinical practice
• \) Patients with diameter stenosis \>30% by CCTA but without coronary revascularization

You may not qualify if:

• \) Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
• \) Coronary lesion with heavy calcification
• \) Chronic renal insufficiency (Serum creatinine \>2.0mg/dL)
• \) Severe liver dysfunction (aspartate transaminase or alanine transferase \> 5 times of upper normal limit)
• \) Pregnancy or potential pregnancy
• \) Life expectancy less than 5 year

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (4)

Fuwai Hospital

Beijing, 200000, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, 200032, China

RECRUITING

Shanghai Tenth People's Hospital

Shanghai, China

RECRUITING

Universal Medical Imaging Diagnostic

Shanghai, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 28088338 BACKGROUND

• 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.

  PMID: 31248544 BACKGROUND

• Dai N, Tang X, Weng X, Cai H, Zhuang J, Yang G, Zhou F, Wu P, Liu B, Duan S, Yu Y, Guo W, Ju Z, Zhang L, Wang Z, Wang Y, Lu B, Shi H, Qian J, Ge J. Sex Differences in Coronary Inflammation and Atherosclerosis Phenotypes in Response to Imaging Marker of Stress-Related Neural Activity. Circ Cardiovasc Imaging. 2024 Feb;17(2):e016057. doi: 10.1161/CIRCIMAGING.123.016057. Epub 2024 Feb 20.

  PMID: 38377235 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Junbo Ge, Professor

  Fudan University

  STUDY CHAIR

Central Study Contacts

Neng Dai, MD

CONTACT

+8613701997266; niceday1987@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: January 1, 2015
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Locations

CN (4)