Role of Tryptase Levels in Patients With Stable Coronary Artery Disease.

Recruiting

• Conditions: Chronic Coronary Syndrome

• Registration Number: NCT06958016
• Lead Sponsor: University of Thessaly

Brief Summary

The aim of this study is to measure the levels of serum tryptase and correlate them with the severity of coronary artery disease in study population. In addition, it will evaluate the usability of tryptase levels as a prognostic biomarker for future cardiovascular events.

Detailed Description

Coronary artery disease (CAD) is the leading cause of death worldwide based on WHO' s latest review in 2019 with CAD being responsible for the 16% of them. The main feature of coronary artery disease is the accumulation of atherosclerotic plaque in the epicardial arteries whether obstructive or non-obstructive. CAD is further subclassified into Chronic Coronary Syndrome (CCS) and Acute Coronary Syndrome (ACS). Patients with CCS experience long and stable periods of myocardial ischemia. However, in the case of a plaque rapture these patients can turn into ACS patients. The objective of this study is to predict that sudden shifting of patients from CCS to ACS by associating the role of inflammation and its factors with cardiovascular events. In particular, it focuses on mast cell (MC) tryptase which provokes plaque instability in patients with CCS. Mast cells needs to be activated to release tryptase and their activation mechanism seems to be the bridging point between tryptase and coronary artery disease. Previous studies have shown that IgE levels, which is the most potent activator of MC, are found high in hyperlipidemic patients. In addition, oxidized LDL (Ox-LDL) is another MC activator.

In reference to the fact that there might be a correlation between tryptase and coronary plaque instability in patients with chronic coronary syndrome, the investigator propose an interventional study for the role of tryptase as a prognostic biomarker in patients with CCS by studying a large population of Greek subjects with CCS.

The study will be conducted on 2 patient population:

1. Patients without coronary artery disease (estimated stenosis \<70%) - Control group

2. Patients with coronary artery disease (estimated stenosis \>70%) - CAD group

Study Timeline

• Study Start: 2024-01-12
• Study First Submitted: 2025-04-23
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-02
• Study First Posted: 2025-05-06
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-01-11
• Study Completion: 2027-01-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male and female subjects aged 18 - 85 years old.
• Clinical symptoms of angina which are classified based on the Canadian Cardiovascular Score (CCS score)
• Positive SPECT scan for myocardial ischemia

Exclusion Criteria

• Acute Coronary Syndrome 4 weeks before the coronary catheterization
• Percutaneous Coronary Angioplasty
• Coronary Artery Bypass Graft
• Active symptoms of allergy (asthma, urticaria)
• Mastocytosis
• Hypereosinophilia
• Autoimmune disease
• Cancer
• Kidney failure
• Myelodysplastic Syndrome
• Denial of signing informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum tryptase levels as a biomarker in CCS	Baseline	Correlation of tryptase levels with Coronary Artery Disease gravity

Secondary Outcome Measures

Name	Time	Method
Tryptase and major cardiovascular evens	12 months after the completion of recruitment	Correlation of tryptase levels with possible major cardiovascular events (death, myocardial infarction)

Trial Locations

Locations (2)

417 Military Hospital NIMTS; 🇬🇷 Athens, Attica, Greece

Larissa University Hospital; 🇬🇷 Larissa, Thessaly, Greece