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Recruiting 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

— Observational Acute Coronary Syndromes Flow Mediated Dilation Endothelial Function (FMD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation group.
Who it may be relevant to
Registry conditions: Acute Coronary Syndromes, Flow Mediated Dilation, Endothelial Function (FMD). Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Brachial artery endothelial function assessment using the Cor-IS method compared to FMD [Time frame: 12 months]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 1 center
  • Ippokratio General Hospital — Thessaloniki

Identifiers

NCT: NCT06890013 · 198/31.5.2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗