Actively Recruiting

Age: 18Years - 85Years
All Genders
ID06890013

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

Led by Aristotle University Of Thessaloniki · Updated on 2026-03-02

100

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective, single-center observational study to understand how flow mediated dilatation (FMD) can predict outcomes in patients with acute coronary syndromes (ACS). This study also evaluates the use of a new method called Cor-IS technology alongside echocardiographic and biochemical measurements. The study focuses on patients hospitalized with ACS, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). Participants will undergo assessments of their endothelial function using two methods: traditional flow mediated dilatation of the brachial artery and the novel Cor-IS technology. They will also receive transthoracic echocardiograms and have blood samples taken to measure plasma biomarkers. All evaluations are observational, meaning no treatments are assigned by the study. These procedures aim to monitor heart function and biochemical markers over time. During the study, researchers will track patient outcomes for 12 months, focusing on measures such as brachial artery function, major adverse cardiac events (MACE), rehospitalizations for angina, need for revascularization, and heart failure occurrences. Participants must be able to consent and follow the study’s schedule. This helps researchers gather comprehensive data on the predictive value of the tested methods in ACS. The total participation covers the initial hospitalization and follow-up assessments during the year after enrollment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Hospitalized patients diagnosed with acute coronary syndrome (STEMI or NSTEMI)
  • Ability to provide written informed consent
  • Ability to comply with the study follow-up schedule
Not Eligible

You will not qualify if you...

  • Acute coronary syndromes classified as MINOCA or type II myocardial infarction
  • Rare acute coronary syndrome types such as spontaneous coronary artery dissection or Takotsubo syndrome
  • Congenital heart disease
  • Age greater than 85 years
  • End stage chronic kidney disease
  • Active malignancy or autoimmune diseases limiting survival
  • Expected survival less than 1 year due to other reasons
  • Suboptimal echocardiographic windows
  • Inability to provide written consent
  • Inability to comply with follow-up schedule
  • Pregnancy
  • Use of intravenous drugs

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - During hospitalization

Participants hospitalized due to acute coronary syndromes undergo endothelial function assessment using flow mediated dilatation of the brachial artery and Cor-IS technology, transthoracic echocardiogram, and plasma biomarkers measurement.

1 visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are monitored for up to 12 months to assess cardiovascular outcomes including major adverse cardiac events, rehospitalizations, need for revascularization, and heart failure.

Follow-up visits as per routine clinical care

Trial Site Locations

Total: 1 location

1

Ippokratio General Hospital

Thessaloniki, Greece, 54642

Actively Recruiting

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Research Team

C

Christodoulos E. Papadopoulos, PhD

G

Georgios Zormpas, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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