sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization

NCT ID: NCT05686057

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-03-31

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 The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group.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

Conditions

Myocardial Ischemia; Heart Failure; Coronary Intervention

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

single vessel diseased patients

sST2 level will be withdrawn at the baseline and after successful PCI

percutanous coronary angiography with stenting

Intervention Type: DEVICE

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.

2 vessels diseased patients

sST2 level will be withdrawn at the baseline and after successful PCI

percutanous coronary angiography with stenting

Intervention Type: DEVICE

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.

multivessels diseased patients

sST2 level will be withdrawn at the baseline and after successful PCI

percutanous coronary angiography with stenting

Intervention Type: DEVICE

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.

non-ischemic control patients

sST2 level will be withdrawn at the baseline

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

South Valley University

OTHER

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Areej Ahmad Abdullah Tammam Alkhateeb

Lecturer of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South Valley University Hospital

Qina, , Egypt

Site Status: RECRUITING

South Valley University

Qina, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Alkhateeb

Role: CONTACT

areejalkhateeb@med.svu.edu.eg

+201023858689

Facility Contacts

Areej AA Alkhateeb, Msc

Role: primary

areejalkhateeb@med.svu.edu.eg

+201023858689

Alkhateeb

Role: primary

areejalkhateeb@med.svu.edu.eg

+201023858689

Other Identifiers

SVU2023

Identifier Type: -

Identifier Source: org_study_id