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CompletedNCT04797819Updated Mar 24, 2021

Serum Soluble ST2 and Plaque Vulnerability in Patients With Acute Coronary Syndrome

An observational study in Acute Coronary Syndrome, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 75 Years
Sex
All
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Study 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 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).

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Conditions studied

  • Acute Coronary Syndrome

Keywords

  • soluble ST2
  • plaque vulnerability
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In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 120 is below the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Between January 2019 and December 2019, a total of 120 patients with 167 lesions were included in our study for final analysis.

Inclusion criteria

  1. Clinical diagnosis of non-ST-elevation ACS

    1. Non-ST-elevation myocardial infarction
    2. Unstable angina
  2. Age from 18 to 75 years
  3. Underwent CCTA

Exclusion criteria

Exclusion Criteria:

  1. Patients needed an immediate (\< 2 h) or early invasive strategy (\< 24 h) according to guidelines:

    1. Haemodynamic instability
    2. Cardiogenic shock
    3. Life-threatening arrhythmias or cardiac arrest
    4. Mechanical complication
    5. Acute heart failure
    6. Dynamic ST or T wave changes
    7. GRACE score > 140
  2. Patients with previous history of:

    1. Coronary artery bypass graft surgery or percutaneous coronary intervention (PCI)
    2. Immune system disorder
    3. Tumor
    4. Acute/chronic infection
    5. Statin use within 3 months
    6. Atrial fibrillation
    7. End-stage renal failure
    8. Iodine-containing contrast allergy
  3. Patients with no significant (≥ 50%) stenosis on major epicardial vessels after CCTA performance
  4. Patients refused subsequent angiography after CCTA performance
  5. Patients with total obstruction on major epicardial vessel
  6. Patients with insufficient image quality for QAngioCT analysis
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • Diagnostic testCoronary plaque components

    Coronary plaque components were detected by CCTA method

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Procedure (Coronary CTA )

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Study locations

1 site
  • Cardiology, Ren Ji Hospital
    Shanghai, China
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04797819
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Mar 15, 2021
Start date
Jan 1, 2019
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Mar 24, 2021

Study contacts

Song Ding
principal investigator · RenJi Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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