An observational study in Chronic Coronary Syndrome, sponsored by University of Thessaly. Recruiting at 2 sites in Greece. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by University of Thessaly · Observational
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.
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:
5,600 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 200 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of Thessaly is the lead sponsor of 188 studies on the registry; 44 are open to participants now.
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This is a multicentre study which take place at the military hospital 417 NIMTS, Athens and the Larissa University Hospital, Larissa. Participants from both locations are patients who are going to undergo percutaneous coronary intervention. These patients will enter the study after fulfiling the inclusion criteria.
Exclusion Criteria:
Patients with angiographically proven coronary artery stenosis \>70%
Patients with angiographically proven coronary artery stenosis \<70%
Serum tryptase levels as a biomarker in CCS
Correlation of tryptase levels with Coronary Artery Disease gravity
Time frame: Baseline
Tryptase and major cardiovascular evens
Correlation of tryptase levels with possible major cardiovascular events (death, myocardial infarction)
Time frame: 12 months after the completion of recruitment
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University of Thessaly