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

NCT06958016 | Recruiting

• 1 other identifier: 447
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Coronary Syndrome

Keywords

chronic coronary syndrome; tryptase; biomarker; mast cell activation; plaque instability; prognosis; MACE; Stable Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Serum tryptase levels as a biomarker in CCS

  Correlation of tryptase levels with Coronary Artery Disease gravity

  Baseline

Secondary Outcomes (1)

• Tryptase and major cardiovascular evens

  12 months after the completion of recruitment

Study Arms (2)

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%

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (2)

417 Military Hospital NIMTS

Athens, Attica, 11521, Greece

RECRUITING

Larisa University Hospital

Larissa, Thessaly, 41334, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

Study Officials

• Grigorios Giamouzis, PhD Medicine

  University of Thessaly

  STUDY DIRECTOR

Central Study Contacts

Fotios Skoufis, MD Medicine

CONTACT

+306981088650; fskoufis@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 6, 2025
• Study Start: January 12, 2024
• Primary Completion: January 11, 2026
• Study Completion (Estimated): January 11, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

GR (2)