sST2 Biomarker Level in Acute/Chronic Coronary Syndrome After Revascularization

NCT05686057 | Unknown

• 1 other identifier: SVU2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Myocardial Ischemia; Heart Failure; Coronary Intervention

Keywords

sST2 biomarker; Modified Gensini Score; Revascularization

Outcome Measures

Primary Outcomes (2)

• sST2 biomarker level

  baseline comparison between ischemic heart disease and non-ischemic heart disease-control groups

  24 hours before intervention

• sST2 biomarker level

  follow up of only ischemic heart disease groups of sST2 level changes after intervention

  48 hours post percutanous coronary intervention

Study Arms (4)

single vessel diseased patients

sST2 level will be withdrawn at the baseline and after successful PCI

Device: percutanous coronary angiography with stenting

2 vessels diseased patients

sST2 level will be withdrawn at the baseline and after successful PCI

Device: percutanous coronary angiography with stenting

multivessels diseased patients

sST2 level will be withdrawn at the baseline and after successful PCI

Device: percutanous coronary angiography with stenting

non-ischemic control patients

sST2 level will be withdrawn at the baseline

Interventions

percutanous coronary angiography with stenting 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; multivessels diseased patients; single vessel diseased patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead
• South Valley University: collaborator

Study Sites (2)

South Valley University Hospital

Qina, 83523, Egypt

RECRUITING

South Valley University

Qina, Egypt

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Heart Failure

Interventions

Stents

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Alkhateeb

CONTACT

+201023858689; areejalkhateeb@med.svu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Cardiology

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)