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NCT Number: NCT06958016

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

417 Military Hospital NIMTS, Athens, Attica, Greece

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About this study

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:

  • Patients without coronary artery disease (estimated stenosis <70%) - Control group
  • Patients with coronary artery disease (estimated stenosis >70%) - CAD group

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Serum tryptase levels as a biomarker in CCS

    Time frame: Baseline

    Correlation of tryptase levels with Coronary Artery Disease gravity

Secondary outcomes

  1. Tryptase and major cardiovascular evens

    Time frame: 12 months after the completion of recruitment

    Correlation of tryptase levels with possible major cardiovascular events (death, myocardial infarction)

Study contacts

Contact information is provided by the study sponsor or research team.

Fotios Skoufis, MD Medicine

CONTACT

[email protected]

+306981088650

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

Investigation of the Role and Prognostic Value of Tryptase in Patients With Stable Coronary Artery Disease

Acronym: TRY-CAD

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 6, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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