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

NCT ID: NCT04797819

Last Updated: 2021-03-24

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

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Serum sST2 level < 14.5 ng/mL

Coronary plaque components

Intervention Type DIAGNOSTIC_TEST

Coronary plaque components were detected by CCTA method

14.5 ng/mL ≤ Serum sST2 level < 20.5 ng/mL

Coronary plaque components

Intervention Type DIAGNOSTIC_TEST

Coronary plaque components were detected by CCTA method

20.5 ng/mL ≤ Serum sST2 level < 25.9 ng/mL

Coronary plaque components

Intervention Type DIAGNOSTIC_TEST

Coronary plaque components were detected by CCTA method

Serum sST2 level ≥ 25.9 ng/mL

Coronary plaque components

Intervention Type DIAGNOSTIC_TEST

Coronary plaque components were detected by CCTA method

Interventions

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Coronary plaque components

Coronary plaque components were detected by CCTA method

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Song Ding

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

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Cardiology, Ren Ji Hospital

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 34368249 (View on PubMed)

Other Identifiers

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sST2 and plaque vulnerability

Identifier Type: -

Identifier Source: org_study_id

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