Identifying the Role of Flow Mediated Dilatation Assessment in Acute Coronary Syndromes - Evaluation of the Cor-IS Technology (the FLARE-ACS Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Brachial artery endothelial function assessment using the Cor-IS method compared to FMD
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Patients with end stage chronic kidney disease
- •Patients with active malignancy or autoimmune diseases which limit their survival
- •Patients with expected survival < 1 year due to other reasons
- •Suboptimal echocardiographic windows
- •Inability to provide written consent
- •Inability to comply with the follow-up schedule of the study
- •Use of intravenous drugs
Arms & Interventions
Observation group
Patients hospitalized due to acute coronary syndromes (STEMI, NSTEMI)
Intervention: Observation group (Diagnostic Test)
Outcomes
Primary Outcomes
Brachial artery endothelial function assessment using the Cor-IS method compared to FMD
Time Frame: 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 Outcomes
- FMD% index and MACE(12 months)
- R-index and need for revascularization(12 months)
- R-index and MACE(12 months)
- FMD% index and rehospitalizations for angina(12 months)
- R-index and rehospitalizations for angina(12 months)
- FMD% index and need for revascularization(12 months)
- FMD% index and heart failure(12 months)
- R-index and heart failure(12 months)