Role of Tryptase Levels in Patients With Stable Coronary Artery Disease.
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Coronary Syndrome. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of the Role and Prognostic Value of Tryptase in Patients With Stable Coronary Artery Disease
Overview
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
Primary outcome measures
- Serum tryptase levels as a biomarker in CCS [Time frame: Baseline]
Secondary outcome measures (1)
- Tryptase and major cardiovascular evens [Time frame: 12 months after the completion of recruitment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Greece · 2 centers
- 417 Military Hospital NIMTS — Athens
- Larisa University Hospital — Larissa
Identifiers
NCT: NCT06958016 · 447