Health TrialsbyHealthPanel

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

ConditionsAcute Coronary SyndromesFlow Mediated DilationEndothelial Function (FMD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorAristotle University Of Thessaloniki

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Observation group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

FMD% index and MACE

Correlation of the FMD% index with the 3-point MACE (cardiovascular death, non-fatal acute myocardial infarction, stroke)

Time frame
12 months
2

R-index and MACE

Correlation of the R-index with the 3-point MACE (cardiovascular death, non-fatal acute myocardial infarction, stroke).

Time frame
12 months
3

FMD% index and rehospitalizations for angina

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

Time frame
12 months
4

R-index and rehospitalizations for angina

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aristotle University Of Thessaloniki

Lead sponsor

Source ClinicalTrials.gov
Apply now