sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization

Recruiting

• Conditions: Coronary Intervention; Myocardial Ischemia; Heart Failure

• Registration Number: NCT05686057
• Lead Sponsor: Assiut University

Brief Summary

The role of soluble circulating suppression of tumorigenicity 2 biomarker (sST2) in the ischemic heart disease patient is a debatable point. Therefore the aims of this study are to assess the plasma level of sST2 in ischemic heart disease patients versus non-ischemic ones, the acute changes in its level after percutaneous coronary intervention (PCI) and its relation to the severity of ischemia.

Detailed Description

A comparison of ischemic patients and non-ischemic controls will be done. The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group. Then a study ischemic group will be divided into three subgroups; subgroup-1: single vessel disease, subgroup-2: two vessels disease and subgroup-3: multivessels disease. On admission, there will be a significant difference between the group of acute/chronic coronary syndrome cases and controls as regard sST2 plasma level or not. Moreover, the differences between the three ischemic subgroups at the baseline ST2 level will be assessed. The plasma sST2 level after PCI and the correlation between the acute change in pot-PCI sST2 level and the severity of ischemia by Modified Gensini Score (MGS) will be evaluated. The final question that will be answered by this study does the rapid impact of PCI on sST2 level will be mainly related to the severity of ischemia rather than left ventricular function or not.

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-06
• Last Update Submitted: 2023-01-06
• Study First Posted: 2023-01-17
• Last Update Posted: 2023-01-17
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Any patients aged 40 years or more and have the risk factors of ischemic heart disease (IHD) with coronary artery disease symptoms will be included.
• For control subjects should be aged ≥ 40 years old with IHD risk factors including DM and HTN and without any symptoms or signs of cardiac ischemia.

Exclusion Criteria

• Any patient with heart failure (EF <50%), any patients with rhythm abnormalities including atrial fibrillation, obese patients, structural heart diseases, uncontrolled chronic diseases such as hypertension or diabetes mellitus, any pulmonary artery or parenchymal diseases up to respiratory failure, acute systemic infection or inflammation, and chronic/acute renal diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sST2 biomarker level	48 hours post percutanous coronary intervention	follow up of only ischemic heart disease groups of sST2 level changes after intervention

Trial Locations

Locations (2)

South Valley University Hospital; 🇪🇬 Qinā, Egypt

South Valley University; 🇪🇬 Qinā, Egypt