Acute Coronary Syndrome (ACS), Endothelial Dysfunction, Reactive Hyperemia
Conditions
Keywords
acute conary syndrome, endothelial dysfunction, olive leaf extract
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.
Interventions
DRUGAtherolive 500mg/day
Patients will receive a study drug (olive leaf extracts) which will be prescribed at dose of 250 mg (one capsule ) twice daily ( total500mg daily) for one month. patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ).
DRUGAtherolive 1000/day
Patients will receive a study drug (olive leaf extracts) which will be prescribed at dose of 500 mg (two capsule ) twice daily ( total 1000mg daily) for one month. patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ).
DRUGPlacbo_Atherolive
Patients will receive placebo which will be prescribed one capsule twice daily for one months. patients will be assigned to one of three arm using a computer-generated randomization list ( 1:1:1 allocation ).
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants will be randomly assigned to one of three groups: Intervention Group 1:Patients in this group will receive the study drug (olive leaf extract) at a dose of 500 mg (two capsules) twice daily, for a total of 1000 mg per day, for one month. Intervention Group 2:Patients in this group will receive the study drug (olive leaf extract) at a dose of 250 mg (one capsule) twice daily, for a total of 500 mg per day, for one month. Control Group:Patients in this group will receive a placebo, with one capsule prescribed twice daily, for one month.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactive Hyperemia Index (RHI) | 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
| Measure | Time frame | Description |
|---|---|---|
| MACE rate | 30-day | -The MACE (Major Adverse Cardiovascular Events) rate will include the following components: Myocardial infarction readmission Nonfatal stroke readmission Cardiovascular death Coronary revascularization, including percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) Admission for heart failure |
Contacts
Primary ContactSemir Nouira, Pr
Backup Contactkhouloud boukhris, PhD Student
Outcome results
None listed