sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05686057

Collaborator

South Valley University (Other)

100

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Ischemia Heart Failure Coronary Intervention	Device: percutanous coronary angiography with stenting

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 The plasma level of sST2 will be withdrawn at baseline and 24-48 hours after the intervention in ischemic group.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

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
single vessel diseased patients sST2 level will be withdrawn at the baseline and after successful PCI	Device: percutanous coronary angiography with stenting Revascularization will be done by percutanous intervention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.
2 vessels diseased patients sST2 level will be withdrawn at the baseline and after successful PCI	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.
multivessels diseased patients sST2 level will be withdrawn at the baseline and after successful PCI	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.
non-ischemic control patients sST2 level will be withdrawn at the baseline

Outcome Measures

Primary Outcome Measures

sST2 biomarker level [24 hours before intervention]
baseline comparison between ischemic heart disease and non-ischemic heart disease-control groups
sST2 biomarker level [48 hours post percutanous coronary intervention]
follow up of only ischemic heart disease groups of sST2 level changes after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Valley University Hospital	Qinā		Egypt	83523
2	South Valley University	Qinā		Egypt

Sponsors and Collaborators

Assiut University
South Valley University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Areej Ahmad Abdullah Tammam Alkhateeb, Lecturer of Cardiology, Assiut University

ClinicalTrials.gov Identifier:

NCT05686057

Other Study ID Numbers:

SVU2023

First Posted:

Jan 17, 2023

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Areej Ahmad Abdullah Tammam Alkhateeb, Lecturer of Cardiology, Assiut University

sST2 biomarker

Modified Gensini Score

Revascularization

Additional relevant MeSH terms:

Myocardial Ischemia

Ischemia

Study Results

No Results Posted as of Jan 17, 2023