Clinical trial 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: The Novel Cor-IS Technology Will Also be Evaluated
Official title: Identifying the Role of Flow Mediated Dilatation Assessment in Acute Coronary Syndromes - Evaluation of the Cor-IS Technology (the FLARE-ACS Trial)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndromes
Flow Mediated Dilation
Endothelial Function (FMD)
Keywords: acute coronary syndrome
endothelial dysfunction
biomarker
flow mediated dilatation
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI) are considered eligible for the study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brachial artery endothelial function assessment using the Cor-IS method compared to FMD
timeFrame: 12 months
Secondary outcomes:
measure: FMD% index and MACE
timeFrame: 12 months
measure: R-index and MACE
timeFrame: 12 months
measure: FMD% index and rehospitalizations for angina
timeFrame: 12 months
measure: R-index and rehospitalizations for angina
timeFrame: 12 months
measure: FMD% index and need for revascularization
timeFrame: 12 months
measure: R-index and need for revascularization
timeFrame: 12 months
measure: FMD% index and heart failure
timeFrame: 12 months
measure: R-index and heart failure
timeFrame: 12 months
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Ippokratio General Hospital
Study officials:
affiliation: Aristotle University of Thessaloniki, Greece
name: Christodoulos E. Papadopoulos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aristotle University of Thessaloniki, Greece
name: Georgios Zormpas, MD
role: PRINCIPAL_INVESTIGATOR
References: