Acute Coronary SyndromeNCT04797819
Serum Soluble ST2 and Plaque Vulnerability 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 assess the association between serum sST2 level and plaque vulnerability in ACS patients. It is hypothesized that serum sST2 level may be related to plaque components and closely associated with plaque vulnerability. 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?
- Coronary plaque components
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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
- Adult, Older adult
Study population: Between January 2019 and December 2019, a total of 120 patients with 167 lesions were included in our study for final analysis.
Who may be able to join
- Clinical diagnosis of non-ST-elevation ACS
- Non-ST-elevation myocardial infarction
- Unstable angina
- Age from 18 to 75 years
- Underwent CCTA
Who cannot join
- Patients needed an immediate (< 2 h) or early invasive strategy (< 24 h) according to guidelines:
- Haemodynamic instability
- Cardiogenic shock
- Life-threatening arrhythmias or cardiac arrest
- Mechanical complication
- Acute heart failure
Show all 21Show fewer
- Dynamic ST or T wave changes
- GRACE score > 140
- Patients with previous history of:
- Coronary artery bypass graft surgery or percutaneous coronary intervention (PCI)
- Immune system disorder
- Tumor
- Acute/chronic infection
- Statin use within 3 months
- Atrial fibrillation
- End-stage renal failure
- Iodine-containing contrast allergy
- Patients with no significant (≥ 50%) stenosis on major epicardial vessels after CCTA performance
- Patients refused subsequent angiography after CCTA performance
- Patients with total obstruction on major epicardial vessel
- Patients with insufficient image quality for QAngioCT analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elevated Serum Soluble ST2 Level is Associated With Increased Plaque Vulnerability in Patients With Non-ST Elevation Acute Coronary Syndrome
This study aimed to assess the association between serum sST2 level and plaque vulnerability in ACS patients. It is hypothesized that serum sST2 level may be related to plaque components and closely associated with plaque vulnerability.
Read the detailed description
Serum soluble suppression of tumorigenicity-2 (sST2) has emerged as a novel biomarker of atherosclerotic disease. This study aimed to investigate whether elevated serum sST2 level is related to coronary plaque components detected on coronary computed tomography angiography (CCTA) and plaque vulnerability in non-ST elevation acute coronary syndromes (ACS) patients. 167 lesions in 120 non-ST elevation ACS patients were prospectively enrolled and evaluated by CCTA in this study. Blood were taken from antecubital vein during patient's hospitalization for angiography. Serum sST2 level was measured by commerical ELISA kits (Presage ST2 Assay Kit, Critical Diagnostics). CCTA were performed using a 320-slice CT scanner (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan). Coronary plaque components were analyzed cross each of the lesions using commercialized software package (QAngio CT, Medis, The Netherlands).
- Conditions
- Acute Coronary Syndrome
- Being tested
- Coronary plaque components
- Keywords
- soluble ST2, plaque vulnerability
- 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.
Coronary plaque componentsDiagnostic test
Coronary plaque components were detected by CCTA method
| Study group | Role | What they receive |
|---|---|---|
| Serum sST2 level < 14.5 ng/mL | Not described Receives: Diagnostic Test: Coronary plaque components | |
| 14.5 ng/mL ≤ Serum sST2 level < 20.5 ng/mL | Not described Receives: Diagnostic Test: Coronary plaque components | |
| 20.5 ng/mL ≤ Serum sST2 level < 25.9 ng/mL | Not described Receives: Diagnostic Test: Coronary plaque components | |
| Serum sST2 level ≥ 25.9 ng/mL | Not described Receives: Diagnostic Test: Coronary plaque components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of plaque components by QAngioCT
Hounsfield unit (HU) -30 to 75 for necrotic core, HU 76-130 for fibrous fatty, HU 131-350 for fibrous tissue, and HU over 351 for dense calcium.
Measured: Procedure (Coronary CTA )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- 120 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
- NCT04797819
- Sponsor's protocol ID
- sST2 and plaque vulnerability
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luo G, Qian Y, Sheng X, Sun J, Wu Z, Liao F, Feng Q, Yin Y, Ding S, Pu J. Elevated Serum Levels of Soluble ST2 Are Associated With Plaque Vulnerability in Patients With Non-ST-Elevation Acute Coronary Syndrome. Front Cardiovasc Med. 2021 Jul 22;8:688522. doi: 10.3389/fcvm.2021.688522. eCollection 2021.
PubMed 34368249
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Serum Soluble ST2 Level is Associated With Increased Plaque Vulnerability in Patients With Non-ST Elevation Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04797819
- Acronym / sponsor ID
- sST2 and plaque vulnerability
- Conditions
- Acute Coronary Syndrome
- Keywords
- soluble ST2, plaque vulnerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 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 assess the association between serum sST2 level and plaque vulnerability in ACS patients. It is hypothesized that serum sST2 level may be related to plaque components and closely associated with plaque vulnerability.
Detailed description
Serum soluble suppression of tumorigenicity-2 (sST2) has emerged as a novel biomarker of atherosclerotic disease. This study aimed to investigate whether elevated serum sST2 level is related to coronary plaque components detected on coronary computed tomography angiography (CCTA) and plaque vulnerability in non-ST elevation acute coronary syndromes (ACS) patients. 167 lesions in 120 non-ST elevation ACS patients were prospectively enrolled and evaluated by CCTA in this study. Blood were taken from antecubital vein during patient's hospitalization for angiography. Serum sST2 level was measured by commerical ELISA kits (Presage ST2 Assay Kit, Critical Diagnostics). CCTA were performed using a 320-slice CT scanner (Aquilion ONE, Toshiba Medical Systems, Otawara, Japan). Coronary plaque components were analyzed cross each of the lesions using commercialized software package (QAngio CT, Medis, The Netherlands).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Serum sST2 level < 14.5 ng/mL | – | Diagnostic Test: Coronary plaque components |
| 14.5 ng/mL ≤ Serum sST2 level < 20.5 ng/mL | – | Diagnostic Test: Coronary plaque components |
| 20.5 ng/mL ≤ Serum sST2 level < 25.9 ng/mL | – | Diagnostic Test: Coronary plaque components |
| Serum sST2 level ≥ 25.9 ng/mL | – | Diagnostic Test: Coronary plaque components |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Between January 2019 and December 2019, a total of 120 patients with 167 lesions were included in our study for final analysis.
Key inclusion criteria (5 listed)
- Clinical diagnosis of non-ST-elevation ACS
- Age from 18 to 75 years
- Underwent CCTA
Key exclusion criteria (21 listed)
- Patients needed an immediate (< 2 h) or early invasive strategy (< 24 h) according to guidelines:
- Patients with previous history of:
- Patients with no significant (≥ 50%) stenosis on major epicardial vessels after CCTA performance
- Patients refused subsequent angiography after CCTA performance
- Patients with total obstruction on major epicardial vessel
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 |
|---|---|---|
| Coronary plaque componentsCoronary plaque components were detected by CCTA method | Diagnostic test | 14.5 ng/mL ≤ Serum sST2 level < 20.5 ng/mL, 20.5 ng/mL ≤ Serum sST2 level < 25.9 ng/mL, Serum sST2 level < 14.5 ng/mL, Serum sST2 level ≥ 25.9 ng/mL |
Primary outcome
Distribution of plaque components by QAngioCT
Time frame: Procedure (Coronary CTA )
Hounsfield unit (HU) -30 to 75 for necrotic core, HU 76-130 for fibrous fatty, HU 131-350 for fibrous tissue, and HU over 351 for dense calcium.
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 24 Mar 2021.
- Derived from this study: PubMed 34368249Luo G, Qian Y, Sheng X, Sun J, Wu Z, Liao F, Feng Q, Yin Y, Ding S, Pu J. Elevated Serum Levels of Soluble ST2 Are Associated With Plaque Vulnerability in Patients With Non-ST-Elevation Acute Coronary Syndrome. Front Cardiovasc Med. 2021 Jul 22;8:688522. doi: 10.3389/fcvm.2021.688522. eCollection 2021.
- 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 5 inclusion and 21 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 24 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?
Distribution of plaque components by QAngioCT (time frame: Procedure (Coronary CTA )). 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 NCT04797819, 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 24 Mar 2021.