Effect of Olive Leaf Extracts on Endothelial Dysfunction and Short-term Outcome in Patients With Acute Coronary Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- University of Monastir
- Enrollment
- 300
- Primary Endpoint
- Reactive Hyperemia Index (RHI)
Study Overview
Brief Summary
the study aims to examine the short-term (30 days) effects of olive leaf extract on endothelial function in patients with acute coronary syndrome (ACS).
This investigation will be conducted on patients admitted to the emergency department for ACS. All participants will be screened and included within 24 hours post-ACS event and prior to discharge from the emergency department.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age over 18 years. Patients presenting with ST-segment alterations at rest, including ST elevation, with or without troponin elevation.
- •Patients who have not undergone surgery or have no additional primary percutaneous coronary intervention (P-PCI) planned within 8 weeks from the initial P-PCI.
- •Patients who provide informed consent. Patients available for and willing to adhere to follow-up procedures. Patients without significant cognitive impairment. Patients with a life expectancy of at least 2 years.
Exclusion Criteria
- •Severe LV hypertrophy (>15 mm);
- •Patients with any evidence of inflammatory or malignant disease.
- •Patient having valvular heart disease, pacemaker; cardiogenic shock
- •Patient having any serious non-cardiac disease associated with a life expectancy <1 year
- •Patients undergoing surgery within 30 days
- •Patient having gastrointestinal disorder such as Crohn's disease
Arms & Interventions
Arm A
Atherolive simple dose
Intervention: Atherolive 500mg/day (Drug)
Arm B
Atherolive double dose
Intervention: Atherolive 1000/day (Drug)
Arm C
Palcebo
Intervention: Placbo_Atherolive (Drug)
Outcomes
Primary Outcomes
Reactive Hyperemia Index (RHI)
Time Frame: 30-day
Change in endothelial function will be evaluated using Reactive Hyperemia Index (RHI) via Peripheral Arterial Tonometry (PAT), measured at baseline and after drug administration (olive leaf extract) in patients with acute coronary syndrome.
Secondary Outcomes
- MACE rate(30-day)
Investigators
Pr. Semir Nouira
Professor
University of Monastir