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 (FLARE-ACS)

February 27, 2026 updated by: Aristotle University Of Thessaloniki

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

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

  • Name: Christodoulos E. Papadopoulos, PhD
  • Phone Number: +30 2313312343
  • Email: chrpapado@gmail.com

Study Contact Backup

Study Locations

  • Greece
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Ippokratio General Hospital
        • Contact:
        • Principal Investigator:
          • Christodoulos E. Papadopoulos, PhD
        • Principal Investigator:
          • Georgios Zormpas, MD
        • Sub-Investigator:
          • Georgios Kassimis, PhD
        • Sub-Investigator:
          • Michael Doumas, PhD
        • Sub-Investigator:
          • Aristi Boulmpou, MSc
        • Sub-Investigator:
          • Nikolaos Fragakis, PhD
        • Sub-Investigator:
          • Vassilios Vassilikos, PhD
        • Sub-Investigator:
          • Theodoros Karapantsios, PhD
        • Sub-Investigator:
          • Sotiris Evgenidis, PhD
        • Sub-Investigator:
          • Konstantinos Zacharias, PhD
        • Sub-Investigator:
          • Nikoleta Chatzipapa, MSc

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

Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI) are considered eligible for the study.

Description

Inclusion Criteria:

  1. Age > 18 years
  2. Patients hospitalized due to acute coronary syndrome (STEMI, NSTEMI)
  3. Capability of providing written informed consent
  4. Patients able to comply with the follow-up schedule of the study

Exclusion Criteria:

  1. Patients with acute coronary syndromes classified as MINOCA, or type II myocardial infarction
  2. Patients with rare acute coronary syndrome types, such as spontaneous coronary artery dissection or Takotsubo syndrome
  3. Patients with congenital heart disease
  4. Age > 85 years
  5. Patients with end stage chronic kidney disease
  6. Patients with active malignancy or autoimmune diseases which limit their survival
  7. Patients with expected survival < 1 year due to other reasons
  8. Suboptimal echocardiographic windows
  9. Inability to provide written consent
  10. Inability to comply with the follow-up schedule of the study
  11. Pregnancy
  12. Use of intravenous drugs

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
Intervention / Treatment
Observation group
Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI)
Diagnostic test: Observation group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FMD% index and MACE
Time Frame: 12 months
Correlation of the FMD% index with the 3-point MACE (cardiovascular death, non-fatal acute myocardial infarction, stroke)
12 months
R-index and MACE
Time Frame: 12 months
Correlation of the R-index with the 3-point MACE (cardiovascular death, non-fatal acute myocardial infarction, stroke).
12 months
FMD% index and rehospitalizations for angina
Time Frame: 12 months
Correlation of the FMD% index with the total rehospitalizations for angina.
12 months
R-index and rehospitalizations for angina
Time Frame: 12 months
Correlation of the R-index with the total rehospitalizations for angina.
12 months
FMD% index and need for revascularization
Time Frame: 12 months
Correlation of the FMD% index and need for revascularization within 1 year from study enrollment.
12 months
R-index and need for revascularization
Time Frame: 12 months
Correlation of the R-index and need for revascularization within 1 year from study enrollment.
12 months
FMD% index and heart failure
Time Frame: 12 months
Correlation of the FMD% index and the development of heart failure within 1 year from study enrollment.
12 months
R-index and heart failure
Time Frame: 12 months
Correlation of the R-index and the development of heart failure within 1 year from study enrollment.
12 months

Collaborators and Investigators

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

Sponsor

Aristotle University Of Thessaloniki

Investigators

  • Principal Investigator: Christodoulos E. Papadopoulos, PhD, Aristotle University of Thessaloniki, Greece
  • Principal Investigator: Georgios Zormpas, MD, Aristotle University of Thessaloniki, Greece

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)

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 198/31.5.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Acute Coronary Syndromes

Clinical Trials on Observation group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe