Role of Tryptase Levels in Patients With Stable Coronary Artery Disease. (TRY-CAD)

May 26, 2025 updated by: Fotios Skoufis, University of Thessaly

Investigation of the Role and Prognostic Value of Tryptase 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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11521
        • Recruiting
        • 417 Military Hospital NIMTS
        • Contact:
        • Principal Investigator:
          • Fotios Skoufis, MD Medicine
    • Thessaly
      • Larissa, Thessaly, Greece, 41334
        • Recruiting
        • Larisa University Hospital
        • Contact:
        • Principal Investigator:
          • Fotios Skoufis, MD Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Coronary Artery Disease Group
Patients with angiographically proven coronary artery stenosis >70%
Non-coronary Artery Disease Group
Patients with angiographically proven coronary artery stenosis <70%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum tryptase levels as a biomarker in CCS
Time Frame: Baseline
Correlation of tryptase levels with Coronary Artery Disease gravity
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months after the completion of recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Study Director: Grigorios Giamouzis, PhD Medicine, University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

January 11, 2026

Study Completion (Estimated)

January 11, 2027

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 447 (Other Identifier: Comitato Etico Regione Abruzzo (Submission ID))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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