Acute Coronary Syndromes, Endothelial Function (FMD), Flow Mediated Dilation
Conditions
Keywords
acute coronary syndrome, endothelial dysfunction, biomarker, flow mediated dilatation
Brief summary
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_TESTObservation 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.
Sponsors
Aristotle University Of Thessaloniki
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brachial artery endothelial function assessment using the Cor-IS method compared to FMD | 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
| Measure | Time frame | Description |
|---|---|---|
| FMD% index and MACE | 12 months | Correlation of the FMD% index with the 3-point MACE (cardiovascular death, non-fatal acute myocardial infarction, stroke) |
| R-index and MACE | 12 months | Correlation of the R-index with the 3-point MACE (cardiovascular death, non-fatal acute myocardial infarction, stroke). |
| FMD% index and rehospitalizations for angina | 12 months | Correlation of the FMD% index with the total rehospitalizations for angina. |
| R-index and rehospitalizations for angina | 12 months | Correlation of the R-index with the total rehospitalizations for angina. |
| FMD% index and need for revascularization | 12 months | Correlation of the FMD% index and need for revascularization within 1 year from study enrollment. |
| R-index and need for revascularization | 12 months | Correlation of the R-index and need for revascularization within 1 year from study enrollment. |
| R-index and heart failure | 12 months | Correlation of the R-index and the development of heart failure within 1 year from study enrollment. |
| FMD% index and heart failure | 12 months | Correlation of the FMD% index and the development of heart failure within 1 year from study enrollment. |
Countries
Greece
Contacts
CONTACTChristodoulos E. Papadopoulos, PhD
CONTACTGeorgios Zormpas, MD
PRINCIPAL_INVESTIGATORChristodoulos E. Papadopoulos, PhD
Aristotle University of Thessaloniki, Greece
PRINCIPAL_INVESTIGATORGeorgios Zormpas, MD
Aristotle University of Thessaloniki, Greece
Outcome results
None listed