Acute Coronary SyndromeNCT04792047
Pericoronary Fat Attenuation Index and High-risk Plaque in Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by RenJi Hospital at 1 site in China.
Trial summary
This study aimed to investigate the relationship between CCTA-based pericoronary inflammation and plaque features as well as local immune-inflammatory biomarkers in ACS patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- HRP frequency, plaque compostion and local immune-inflammatory activation
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Jan 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between January 2019 and January 2020, a total of 130 patients with 195 lesions were included in our study for final analysis.
Who may be able to join
- non-ST-elevation ACS (non-ST-elevation myocardial infarction or unstable angina) age from 18 to 75 years which underwent CCTA were prospectively enrolled in this study.
Who cannot join
- Patients needed an immediate (<2 h) or early invasive strategy (<24 h) according to guidelines were excluded: including those presented with haemodynamic instability or cardiogenic shock, life-threatening arrhythmia or cardiac arrest, mechanical complication, acute heart failure, dynamic ST or T wave changes, GRACE score >140;
- Subjects with previous history of coronary artery bypass graft surgery or PCI, immune system disorder, tumor, acute/chronic infection, atrial fibrillation, end-stage renal failure, iodine-containing contrast allergy were also excluded.
- After CCTA performance, we also exclude patients with no significant (≥50%) stenosis on major epicardial vessels and those refused subsequent angiography.
- Participants with total obstruction on major epicardial vessel, or insufficient image quality for FAI and QangioCT analysis, as well as lack of blood sample were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increased Pericoronary Fat Attenuation Index is Associated With High-risk Plaque and Local Immune-inflammatory Activation in Patients With Non-ST Elevation Acute Coronary Syndrome
This study aimed to investigate the relationship between CCTA-based pericoronary inflammation and plaque features as well as local immune-inflammatory biomarkers in ACS patients. It is hypothesized that perivascular FAI might serve as a reliable sensor of coronary immune-inflammatory disorder, and closely related to the plaque vulnerability.
Read the detailed description
The pericoronary fat attenuation index (FAI), which capture by standard coronary computed tomography angiography (CCTA), has emerged as a novel imaging biomarker of coronary inflammation. This study aimed to assess whether increased Pericoronary FAI on CCTA are associated with high-risk plaque (HRP) feature as well as local T cell subsets and their intracellular cytokines levels in non-ST elevation acute coronary syndromes ( ACS) patients. 195 lesions in 130 non-ST elevation ACS patients were prospectively enrolled and evaluated by CCTA and coronary angiography in this study. Blood were taken from coronary artery immediately after the diagnostic angiogram. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry. CCTA and pericoronary FAI examinations were performed using a 320-detecor (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan) Systems. Coronary plaque characteristics were analyzed cross each of the main coronary arteries using commercialized software package (Qangio CT, Medis, The Netherlands).
- Conditions
- Acute Coronary Syndrome
- Being tested
- HRP frequency, plaque compostion and local immune-inflammatory activation
- Keywords
- pericoronary fat attenuation index, high-risk plaque
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRP frequency, plaque compostion and local immune-inflammatory activationDiagnostic test
HRP frequency, plaque compostion were detected by CCTA method. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry.
| Study group | Role | What they receive |
|---|---|---|
| Lesions with perivasular FAI greater than ≥-70.1 | Not described Receives: Diagnostic Test: HRP frequency, plaque compostion and local immune-inflammatory activation | |
| Lesions with perivasular FAI greater than <-70.1 | Not described Receives: Diagnostic Test: HRP frequency, plaque compostion and local immune-inflammatory activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of HRP by CCTA
HRP features were defined according to previous studies as follow: low-attenuation plaque (LAP), mean CT number <30 HU; positive remodeling(PR), remodeling index, >1.1; spotty calcification(SC), intraplaque calcification ≤3 mm; Napkin-ring sign, low intraplaque attenuation surrounded by a higher attenuation rim.
Measured: coronary CTA analysis, before angiography
Secondary outcomes (1)
Distribution of plaque composition by Qangio
HU -30 to 75, for necrotic core;HU 76-130 for fibro-fatty; HU131-350 for fibrous, and HU> 351 for dense calcium.
Measured: coronary CTA analysis, before angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Jan 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Song Ding, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792047
- Sponsor's protocol ID
- FAI and HRP study
- Status last verified
- Feb 2021
- First submitted
- 25 Feb 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun JT, Sheng XC, Feng Q, Yin Y, Li Z, Ding S, Pu J. Pericoronary Fat Attenuation Index Is Associated With Vulnerable Plaque Components and Local Immune-Inflammatory Activation in Patients With Non-ST Elevation Acute Coronary Syndrome. J Am Heart Assoc. 2022 Jan 18;11(2):e022879. doi: 10.1161/JAHA.121.022879. Epub 2022 Jan 13.
PubMed 35023363
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Pericoronary Fat Attenuation Index is Associated With High-risk Plaque and Local Immune-inflammatory Activation in Patients With Non-ST Elevation Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04792047
- Acronym / sponsor ID
- FAI and HRP study
- Conditions
- Acute Coronary Syndrome
- Keywords
- pericoronary fat attenuation index, high-risk plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 10 Mar 2021 (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.
This study aimed to investigate the relationship between CCTA-based pericoronary inflammation and plaque features as well as local immune-inflammatory biomarkers in ACS patients. It is hypothesized that perivascular FAI might serve as a reliable sensor of coronary immune-inflammatory disorder, and closely related to the plaque vulnerability.
Detailed description
The pericoronary fat attenuation index (FAI), which capture by standard coronary computed tomography angiography (CCTA), has emerged as a novel imaging biomarker of coronary inflammation. This study aimed to assess whether increased Pericoronary FAI on CCTA are associated with high-risk plaque (HRP) feature as well as local T cell subsets and their intracellular cytokines levels in non-ST elevation acute coronary syndromes ( ACS) patients. 195 lesions in 130 non-ST elevation ACS patients were prospectively enrolled and evaluated by CCTA and coronary angiography in this study. Blood were taken from coronary artery immediately after the diagnostic angiogram. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry. CCTA and pericoronary FAI examinations were performed using a 320-detecor (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan) Systems. Coronary plaque characteristics were analyzed cross each of the main coronary arteries using commercialized software package (Qangio CT, Medis, The Netherlands).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lesions with perivasular FAI greater than ≥-70.1 | – | Diagnostic Test: HRP frequency, plaque compostion and local immune-inflammatory activation |
| Lesions with perivasular FAI greater than <-70.1 | – | Diagnostic Test: HRP frequency, plaque compostion and local immune-inflammatory activation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between January 2019 and January 2020, a total of 130 patients with 195 lesions were included in our study for final analysis.
Key inclusion criteria (1 listed)
- non-ST-elevation ACS (non-ST-elevation myocardial infarction or unstable angina) age from 18 to 75 years which underwent CCTA were prospectively enrolled in this study.
Key exclusion criteria (4 listed)
- Patients needed an immediate (<2 h) or early invasive strategy (<24 h) according to guidelines were excluded: including those presented with haemodynamic instability or cardiogenic shock, life-threatening arrhythmia or cardiac arrest, mechanical complication, acute heart failure, dynamic ST or T wave changes, GRACE score >140;
- Subjects with previous history of coronary artery bypass graft surgery or PCI, immune system disorder, tumor, acute/chronic infection, atrial fibrillation, end-stage renal failure, iodine-containing contrast allergy were also excluded.
- After CCTA performance, we also exclude patients with no significant (≥50%) stenosis on major epicardial vessels and those refused subsequent angiography.
- Participants with total obstruction on major epicardial vessel, or insufficient image quality for FAI and QangioCT analysis, as well as lack of blood sample were excluded.
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 |
|---|---|---|
| HRP frequency, plaque compostion and local immune-inflammatory activationHRP frequency, plaque compostion were detected by CCTA method. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry. | Diagnostic test | Lesions with perivasular FAI greater than <-70.1, Lesions with perivasular FAI greater than ≥-70.1 |
Primary outcome
Frequency of HRP by CCTA
Time frame: coronary CTA analysis, before angiography
HRP features were defined according to previous studies as follow: low-attenuation plaque (LAP), mean CT number <30 HU; positive remodeling(PR), remodeling index, >1.1; spotty calcification(SC), intraplaque calcification ≤3 mm; Napkin-ring sign, low intraplaque attenuation surrounded by a higher attenuation rim.
1 secondary outcome
Distribution of plaque composition by Qangio
Time frame: coronary CTA analysis, before angiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 35023363Sun JT, Sheng XC, Feng Q, Yin Y, Li Z, Ding S, Pu J. Pericoronary Fat Attenuation Index Is Associated With Vulnerable Plaque Components and Local Immune-Inflammatory Activation in Patients With Non-ST Elevation Acute Coronary Syndrome. J Am Heart Assoc. 2022 Jan 18;11(2):e022879. doi: 10.1161/JAHA.121.022879. Epub 2022 Jan 13.
- Individual participant dataSharing planned: No
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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.
Song Ding principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by RenJi Hospital at 1 site 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of HRP by CCTA (time frame: coronary CTA analysis, before angiography). 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 NCT04792047, which also lists 1 linked publication.
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 10 Mar 2021.