Coronary Artery DiseaseBlueprintNCT05545618
Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 4 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CCTA and 18F-FDG-PET/CT
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2015to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Fuwai Hospital
Beijing, 200000
Lei Wang
- Recruiting
Shanghai Zhongshan Hospital
Shanghai, 200032
Neng Dai, MD, +8613701997266, niceday1987@hotmail.com
- Recruiting
Shanghai Tenth People's Hospital
Shanghai
Haidong Cai
- Recruiting
Universal Medical Imaging Diagnostic
Shanghai
Lu Sun
About this study
Official title: Biological Interconnection of Brain Neurobiological Activity With Atherosclerotic Plaque Vulnerability and the Prognostic Value
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- CCTA and 18F-FDG-PET/CT
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCTA and 18F-FDG-PET/CTDiagnostic test
18F-FDG-PET/CT imaging and comprehensive assessment of coronary plaque with CCTA within 90 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: CCTA and 18F-FDG-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: at the index imaging
Major adverse cardiac events
Death from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina.
Measured: 5 years after index imaging
Secondary outcomes (1)
Cardiovascular death, or nonfatal myocardial infarction
Cardiovascular death, or nonfatal myocardial infarction
Measured: 5 years after index imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Jan 2015
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Professor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545618
- Sponsor's protocol ID
- ZS-2022-9-15
- Acronym
- Blueprint
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28088338Tawakol 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.
PubMed 31248544Dai 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.
PubMed 38377235
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Interconnection of Brain Neurobiological Activity With Atherosclerotic Plaque Vulnerability and the Prognostic Value
- ClinicalTrials.gov ID
- NCT05545618
- Acronym / sponsor ID
- Blueprint / ZS-2022-9-15
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCTA imaging with 18F-FDG-PET/CT assessment | – | Diagnostic Test: CCTA and 18F-FDG-PET/CTGroup of patients with 18F-FDG-PET/CT imaging and Coronary Computed Tomographic Angiography within 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCTA and 18F-FDG-PET/CT18F-FDG-PET/CT imaging and comprehensive assessment of coronary plaque with CCTA within 90 days | Diagnostic test | CCTA imaging with 18F-FDG-PET/CT assessment |
Primary outcome
Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity)
Time frame: 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
Time frame: 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
Time frame: at the index imaging
Coronary inflammation will be assessed by FAI. Correlation Between amygdalar activity and FAI will be assessed
Major adverse cardiac events
Time frame: 5 years after index imaging
Death from coronary heart disease, nonfatal myocardial infarction or hospitalization for unstable angina.
1 secondary outcome
Cardiovascular death, or nonfatal myocardial infarction
Time frame: 5 years after index imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Background: PubMed 28088338Tawakol 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.
- Background: PubMed 31248544Tawakol 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.
- Derived from this study: PubMed 38377235Dai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, Professor study chair
Fudan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neng Dai, MD (+8613701997266, niceday1987@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between amygdalar activity (neurobiological activity) and bone marrow hematopoiesis (hematopoietic activity) (time frame: at the index imaging). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05545618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.