Clinical trial NCT05686057: sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization
Official title: The Effect of Cardiac Ischemia and Percutaneous Coronary Intervention on the Changes of sST2 Level
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Ischemia
Heart Failure
Coronary Intervention
Keywords: sST2 biomarker
Modified Gensini Score
Revascularization
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: South Valley University
First posted: 2023-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All middle-old aged patients with IHD risk factors and acute or chronic coronary syndrome manifestations will undergo all routine investigations at baseline and after 24-48 hours of PCI and the levels of sST2 will be assessed for relations to acute changes in left ventricular EF by using 2-dimensional transthoracic echocardiography (2D-TTE) and the degree of ischemia by using Modified Gensini score. At the same time, the level of sST2 in control group with normal all routine diagnostic investigations will be assessed.

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 The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group.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

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.

Primary outcomes:
measure: sST2 biomarker level
timeFrame: 24 hours before intervention
measure: sST2 biomarker level
timeFrame: 48 hours post percutanous coronary intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University Hospital
city: Qinā
country: Egypt
facility: South Valley University
Study officials:
References: