Acute Coronary SyndromesFLARE-ACSNCT06890013
A Prospective, Single-center, Observational Study Aiming to Assess the Predictive Role of Flow Mediated Dilatation in Acute Coronary Syndromes, Combined With Echocardiographic and Biochemical Indices
An observational study of Acute Coronary Syndromes and Flow Mediated Dilation, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
A prospective, single-center, observational study aiming to assess the predictive role of flow mediated dilatation in acute coronary syndromes, combined with echocardiographic and biochemical indices. The novel Cor-IS technology will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndromes, Flow Mediated Dilation, Endothelial Function (FMD)
- What is being tested?
- Observation group
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2024to 1 Nov 2026
- 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: Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI) are considered eligible for the study.
Who may be able to join
- Age > 18 years
- Patients hospitalized due to acute coronary syndrome (STEMI, NSTEMI)
- Capability of providing written informed consent
- Patients able to comply with the follow-up schedule of the study
Who cannot join
- Patients with acute coronary syndromes classified as MINOCA, or type II myocardial infarction
- Patients with rare acute coronary syndrome types, such as spontaneous coronary artery dissection or Takotsubo syndrome
- Patients with congenital heart disease
- Age > 85 years
- Patients with end stage chronic kidney disease
- Patients with active malignancy or autoimmune diseases which limit their survival
Show all 12Show fewer
- Patients with expected survival < 1 year due to other reasons
- Suboptimal echocardiographic windows
- Inability to provide written consent
- Inability to comply with the follow-up schedule of the study
- Pregnancy
- Use of intravenous drugs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Ippokratio General Hospital
Thessaloniki, 54642
Georgios Zormpas, MD, 2313312343 ext. +30, sparky.zorb@gmail.com
Christodoulos E. Papadopoulos, PhD
About this study
Official title: Identifying the Role of Flow Mediated Dilatation Assessment in Acute Coronary Syndromes - Evaluation of the Cor-IS Technology (the FLARE-ACS Trial)
A prospective, single-center, observational study aiming to assess the predictive role of flow mediated dilatation in acute coronary syndromes, combined with echocardiographic and biochemical indices. The novel Cor-IS technology will also be evaluated.
- Being tested
- Observation group
- Keywords
- acute coronary syndrome, endothelial dysfunction, biomarker, flow mediated dilatation
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation groupDiagnostic test
Patients with acute coronary syndrome undergo endothelial function assessment using two methods (flow mediated dilatation of the brachial artery and Cor-Is technology) transthoracic echocardiogram and plasma biomarkers' measurement.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI) Receives: Diagnostic Test: Observation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial artery endothelial function assessment using the Cor-IS method compared to FMD
The primary outcome of the study is the assessment of brachial artery endothelial function in the therapeutic approach using the Cor-IS method compared to the reference method FMD. The indices of the FMD method (FMD%, shear rate, and FMD/shear) will be compared with the R index of the Cor-IS method at the study's baseline and during follow-up.
Measured: 12 months
Secondary outcomes (8)
FMD% index and MACE
Correlation of the FMD% index with the 3-point MACE (cardiovascular death, non-fatal acute myocardial infarction, stroke)
Measured: 12 months
R-index and MACE
Correlation of the R-index with the 3-point MACE (cardiovascular death, non-fatal acute myocardial infarction, stroke).
Measured: 12 months
FMD% index and rehospitalizations for angina
Correlation of the FMD% index with the total rehospitalizations for angina.
Measured: 12 months
R-index and rehospitalizations for angina
Correlation of the R-index with the total rehospitalizations for angina.
Measured: 12 months
FMD% index and need for revascularization
Correlation of the FMD% index and need for revascularization within 1 year from study enrollment.
Measured: 12 months
R-index and need for revascularization
Correlation of the R-index and need for revascularization within 1 year from study enrollment.
Measured: 12 months
FMD% index and heart failure
Correlation of the FMD% index and the development of heart failure within 1 year from study enrollment.
Measured: 12 months
R-index and heart failure
Correlation of the R-index and the development of heart failure within 1 year from study enrollment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jun 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christodoulos E. Papadopoulos, PhD, Principal investigator, Aristotle University of Thessaloniki, GreeceGeorgios Zormpas, MD, Principal investigator, Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890013
- Sponsor's protocol ID
- 198/31.5.2024
- Acronym
- FLARE-ACS
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Role of Flow Mediated Dilatation Assessment in Acute Coronary Syndromes - Evaluation of the Cor-IS Technology (the FLARE-ACS Trial)
- ClinicalTrials.gov ID
- NCT06890013
- Acronym / sponsor ID
- FLARE-ACS / 198/31.5.2024
- Keywords
- acute coronary syndrome, endothelial dysfunction, biomarker, flow mediated dilatation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 21 Mar 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.
A prospective, single-center, observational study aiming to assess the predictive role of flow mediated dilatation in acute coronary syndromes, combined with echocardiographic and biochemical indices. The novel Cor-IS technology will also be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Diagnostic Test: Observation groupPatients hospitalized due to acute coronary syndromes (STEMI, NSTEMI) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI) are considered eligible for the study.
Key inclusion criteria (4 listed)
- Age > 18 years
- Patients hospitalized due to acute coronary syndrome (STEMI, NSTEMI)
- Capability of providing written informed consent
- Patients able to comply with the follow-up schedule of the study
Key exclusion criteria (12 listed)
- Patients with acute coronary syndromes classified as MINOCA, or type II myocardial infarction
- Patients with rare acute coronary syndrome types, such as spontaneous coronary artery dissection or Takotsubo syndrome
- Patients with congenital heart disease
- Age > 85 years
- Patients with end stage chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation groupPatients with acute coronary syndrome undergo endothelial function assessment using two methods (flow mediated dilatation of the brachial artery and Cor-Is technology) transthoracic echocardiogram and plasma biomarkers' measurement. | Diagnostic test | Observation group |
Primary outcome
Brachial artery endothelial function assessment using the Cor-IS method compared to FMD
Time frame: 12 months
The primary outcome of the study is the assessment of brachial artery endothelial function in the therapeutic approach using the Cor-IS method compared to the reference method FMD. The indices of the FMD method (FMD%, shear rate, and FMD/shear) will be compared with the R index of the Cor-IS method at the study's baseline and during follow-up.
8 secondary outcomes
FMD% index and MACE
Time frame: 12 months
R-index and MACE
Time frame: 12 months
FMD% index and rehospitalizations for angina
Time frame: 12 months
R-index and rehospitalizations for angina
Time frame: 12 months
FMD% index and need for revascularization
Time frame: 12 months
R-index and need for revascularization
Time frame: 12 months
FMD% index and heart failure
Time frame: 12 months
R-index and heart failure
Time frame: 12 months
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 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Christodoulos E. Papadopoulos, PhD principal investigator
Aristotle University of Thessaloniki, Greece
Georgios Zormpas, MD principal investigator
Aristotle University of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes and Flow Mediated Dilation, run by Aristotle University Of Thessaloniki at 1 site 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 4 inclusion and 12 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Christodoulos E. Papadopoulos, PhD (2313312343 ext. +30, chrpapado@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery endothelial function assessment using the Cor-IS method compared to FMD (time frame: 12 months). 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 2 Mar 2026.