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

Acute Coronary Syndrome Clinical Trial

Official title:

Elevated Serum Soluble ST2 Level is Associated With Increased Plaque Vulnerability in Patients With Non-ST Elevation Acute Coronary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797819
• Other study ID #: sST2 and plaque vulnerability
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2021
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Coronary plaque components
Coronary plaque components were detected by CCTA method

Locations

Country	Name	City	State
China	Cardiology, Ren Ji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Procedure (Coronary CTA )