Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events

NCT ID: NCT05545618

Last Updated: 2022-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

CCTA and 18F-FDG-PET/CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CCTA and 18F-FDG-PET/CT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Junbo Ge, Professor

Role: STUDY_CHAIR

Fudan University

Locations

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Fuwai Hospital

Beijing, , China

Site Status RECRUITING

Shanghai Zhongshan Hospital

Shanghai, , China

Site Status RECRUITING

Shanghai Tenth People's Hospital

Shanghai, , China

Site Status RECRUITING

Universal Medical Imaging Diagnostic

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Neng Dai, MD

Role: CONTACT

+8613701997266

Facility Contacts

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Lei Wang

Role: primary

Neng Dai, MD

Role: primary

+8613701997266

Haidong Cai

Role: primary

Lu Sun

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28088338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31248544 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38377235 (View on PubMed)

Other Identifiers

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ZS-2022-9-15

Identifier Type: -

Identifier Source: org_study_id

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