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sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization

A

Assiut University

Status

Enrolling

Conditions

Myocardial Ischemia
Coronary Intervention
Heart Failure

Treatments

Device: percutanous coronary angiography with stenting

Study type

Observational

Funder types

Other

Identifiers

NCT05686057
SVU2023

Details and patient eligibility

About

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.

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 The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group.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

Enrollment

100 estimated patients

Sex

All

Ages

40+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

100 participants in 4 patient groups

single vessel diseased patients
Description:
sST2 level will be withdrawn at the baseline and after successful PCI
Treatment:
Device: percutanous coronary angiography with stenting
2 vessels diseased patients
Description:
sST2 level will be withdrawn at the baseline and after successful PCI
Treatment:
Device: percutanous coronary angiography with stenting
multivessels diseased patients
Description:
sST2 level will be withdrawn at the baseline and after successful PCI
Treatment:
Device: percutanous coronary angiography with stenting
non-ischemic control patients
Description:
sST2 level will be withdrawn at the baseline

Trial contacts and locations

2

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Central trial contact

Alkhateeb

Data sourced from clinicaltrials.gov

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