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NCT Number: NCT06890013

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

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.

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Endothelial Function (FMD) Flow Mediated Dilation Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ippokratio General Hospital

Thessaloniki, 54642, Greece

Location status: Recruiting

Location contact

Aristi Boulmpou, MSc

SUB_INVESTIGATOR

Christodoulos E. Papadopoulos, PhD

PRINCIPAL_INVESTIGATOR

Georgios Kassimis, PhD

SUB_INVESTIGATOR

Georgios Zormpas, MD

CONTACT

[email protected]

2313312343 ext. +30

Georgios Zormpas, MD

PRINCIPAL_INVESTIGATOR

Konstantinos Zacharias, PhD

SUB_INVESTIGATOR

Michael Doumas, PhD

SUB_INVESTIGATOR

Nikolaos Fragakis, PhD

SUB_INVESTIGATOR

Nikoleta Chatzipapa, MSc

SUB_INVESTIGATOR

Sotiris Evgenidis, PhD

SUB_INVESTIGATOR

Theodoros Karapantsios, PhD

SUB_INVESTIGATOR

Vassilios Vassilikos, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Observation group

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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).

  3. FMD% index and rehospitalizations for angina

    Time frame: 12 months

    Correlation of the FMD% index with the total rehospitalizations for angina.

  4. R-index and rehospitalizations for angina

    Time frame: 12 months

    Correlation of the R-index with the total rehospitalizations for angina.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christodoulos E. Papadopoulos, PhD

CONTACT

[email protected]

2313312343 ext. +30

Georgios Zormpas, MD

CONTACT

[email protected]

2313312343 ext. +30

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

Identifying the Role of Flow Mediated Dilatation Assessment in Acute Coronary Syndromes - Evaluation of the Cor-IS Technology (the FLARE-ACS Trial)

Acronym: FLARE-ACS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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