sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization

Study Overview
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Brief Summary
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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
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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 The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group.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.

Official Title
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The Effect of Cardiac Ischemia and Percutaneous Coronary Intervention on the Changes of sST2 Level

Conditions
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Myocardial Ischemia, Heart Failure, Coronary Intervention

Intervention / Treatment
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* Device: percutanous coronary angiography with stenting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single vessel diseased patients<br>sST2 level will be withdrawn at the baseline and after successful PCI | Device: percutanous coronary angiography with stenting<br>* Revascularization will be done by percutanous intervention after assessment of coronary stenosis by diagnostic coronary angiography under local anaesthesia with fluoroscopic guidance in acute/chronic coronary syndrome cases. The severity of stenosis will be done by modified gensini score from angiogram. An sST2 ELIZA test will be done after withdrawal of the cases' samples.<br>|
| 2 vessels diseased patients<br>sST2 level will be withdrawn at the baseline and after successful PCI | Device: percutanous coronary angiography with stenting<br>* Revascularization will be done by percutanous intervention after assessment of coronary stenosis by diagnostic coronary angiography under local anaesthesia with fluoroscopic guidance in acute/chronic coronary syndrome cases. The severity of stenosis will be done by modified gensini score from angiogram. An sST2 ELIZA test will be done after withdrawal of the cases' samples.<br>|
| multivessels diseased patients<br>sST2 level will be withdrawn at the baseline and after successful PCI | Device: percutanous coronary angiography with stenting<br>* Revascularization will be done by percutanous intervention after assessment of coronary stenosis by diagnostic coronary angiography under local anaesthesia with fluoroscopic guidance in acute/chronic coronary syndrome cases. The severity of stenosis will be done by modified gensini score from angiogram. An sST2 ELIZA test will be done after withdrawal of the cases' samples.<br>|
| non-ischemic control patients<br>sST2 level will be withdrawn at the baseline | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sST2 biomarker level | baseline comparison between ischemic heart disease and non-ischemic heart disease-control groups | 24 hours before intervention | 
| sST2 biomarker level | follow up of only ischemic heart disease groups of sST2 level changes after intervention | 48 hours post percutanous coronary intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sST2 biomarker, Modified Gensini Score, Revascularization