sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization

Heart Failure Clinical Trial

— ST2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686057
• Other study ID #: SVU2023
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: March 2023

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Alkhateeb
• Phone: +201023858689
• Email: areejalkhateeb[@]med.svu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• percutanous coronary angiography with stenting
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.

Locations

Country	Name	City	State
Egypt	South Valley University	Qina
Egypt	South Valley University Hospital	Qina

Sponsors (2)

Lead Sponsor	Collaborator
Assiut University	South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sST2 biomarker level	baseline comparison between ischemic heart disease and non-ischemic heart disease-control groups	24 hours before intervention
Primary	sST2 biomarker level	follow up of only ischemic heart disease groups of sST2 level changes after intervention	48 hours post percutanous coronary intervention