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

Aristotle University Of Thessaloniki100 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Acute Coronary Syndromes Flow Mediated Dilation Endothelial Function (FMD)

Interventions

Observation groupDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

FMD% index and rehospitalizations for angina

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

Time frame: 12 months

R-index and rehospitalizations for angina

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

Time frame: 12 months

FMD% index and need for revascularization

Correlation of the FMD% index and need for revascularization within 1 year from study enrollment.

Time frame: 12 months

R-index and need for revascularization

Correlation of the R-index and need for revascularization within 1 year from study enrollment.

Time frame: 12 months

FMD% index and heart failure

Correlation of the FMD% index and the development of heart failure within 1 year from study enrollment.

Time frame: 12 months

R-index and heart failure

Correlation of the R-index and the development of heart failure within 1 year from study enrollment.

Time frame: 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts