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

Recruiting

• Conditions: Acute Coronary Syndromes; Flow Mediated Dilation; Endothelial Function (FMD)

• Registration Number: NCT06890013
• Lead Sponsor: Aristotle University Of Thessaloniki

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-06-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
FMD% index and heart failure	12 months	Correlation of the FMD% index and the development of heart failure 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.

Trial Locations

Locations (1)

Ippokratio General Hospital; 🇬🇷 Thessaloniki, Greece