Chronic Coronary SyndromeTRY-CADNCT06958016
Role of Tryptase Levels in Patients With Stable Coronary Artery Disease.
An observational study of Chronic Coronary Syndrome, run by University of Thessaly at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Coronary Syndrome
- How many people
- 200 participants
- Where
- 2 sitesGreece
- Study dates
- 12 Jan 2024to 11 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Acute Coronary Syndrome 4 weeks before the coronary catheterization
- Percutaneous Coronary Angioplasty
- Coronary Artery Bypass Graft
- Active symptoms of allergy (asthma, urticaria)
- Mastocytosis
- Hypereosinophilia
Show all 11Show fewer
- Autoimmune disease
- Cancer
- Kidney failure
- Myelodysplastic Syndrome
- Denial of signing informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
417 Military Hospital NIMTS
Athens, Attica, 11521
Fotios Skoufis, MD Medicine, 00306981088650, fskoufis@hotmail.com
Fotios Skoufis, MD Medicine
- Recruiting
Larisa University Hospital
Larissa, Thessaly, 41334
Fotios Skoufis, MD Medicine, 00306981088650, fskoufis@hotmail.com
Fotios Skoufis, MD Medicine
About this study
Official title: 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.
Read the 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:
- Patients without coronary artery disease (estimated stenosis <70%) - Control group
- Patients with coronary artery disease (estimated stenosis >70%) - CAD group
- Conditions
- Chronic Coronary Syndrome
- Keywords
- chronic coronary syndrome, tryptase, biomarker, mast cell activation, plaque instability, prognosis, MACE, Stable Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Serum tryptase levels as a biomarker in CCS
Correlation of tryptase levels with Coronary Artery Disease gravity
Measured: Baseline
Secondary outcomes (1)
Tryptase and major cardiovascular evens
Correlation of tryptase levels with possible major cardiovascular events (death, myocardial infarction)
Measured: 12 months after the completion of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start12 Jan 2024
- Primary completion11 Jan 2026 (estimated)
- Study completion11 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fotios Skoufis, University of Thessaly
- Investigators
- Grigorios Giamouzis, PhD Medicine, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958016
- Sponsor's protocol ID
- 447
- Acronym
- TRY-CAD
- Status last verified
- May 2025
- First submitted
- 23 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Role and Prognostic Value of Tryptase in Patients With Stable Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06958016
- Acronym / sponsor ID
- TRY-CAD / 447
- Conditions
- Chronic Coronary Syndrome
- Keywords
- chronic coronary syndrome, tryptase, biomarker, mast cell activation, plaque instability, prognosis, MACE, Stable Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 11 Jan 2026 (estimated)
- Study completion
- 11 Jan 2027 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients without coronary artery disease (estimated stenosis <70%) - Control group
- Patients with coronary artery disease (estimated stenosis >70%) - CAD group
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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% |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Acute Coronary Syndrome 4 weeks before the coronary catheterization
- Percutaneous Coronary Angioplasty
- Coronary Artery Bypass Graft
- Active symptoms of allergy (asthma, urticaria)
- Mastocytosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum tryptase levels as a biomarker in CCS
Time frame: Baseline
Correlation of tryptase levels with Coronary Artery Disease gravity
1 secondary outcome
Tryptase and major cardiovascular evens
Time frame: 12 months after the completion of recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Grigorios Giamouzis, PhD Medicine study director
University of Thessaly
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Coronary Syndrome, run by University of Thessaly at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fotios Skoufis, MD Medicine (+306981088650, fskoufis@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum tryptase levels as a biomarker in CCS (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.