No-Reflow Phenomenon
Conditions
Keywords
No-Reflow Phenomena, Alpha Lipoic Acid, Paraoxonase-1, Aldehyde dehydrogenase-2, Myocardial infarction
Brief summary
Prospective, randomized, open-label, controlled clinical trial to evaluate the efficacy and tolerability of Alpha Lipoic Acid administration on oxidative stress, inflammatory markers, clinical outcome and occurrence of No-Reflow in post myocardial infarction (MI) patients by assessment of aldehyde dehydrogenase-2 (ALDH2) as a marker of oxidative stress and paraoxonase-1 (PON-1) as a marker of oxidative stress and inflammation.
Detailed description
All (70) STEMI patients undergoing PCI presenting to the Cardiology department will be randomly assigned into one of 2 arms: 35 patients undergoing PCI who will receive standard of care , the other 35 patients undergoing PCI will receive standard of care in addition to Alpha Lipoic Acid 600 mg daily for 4 week. IV Alpha Lipoic Acid 600 mg once daily will be administered prior to PCI then orally daily for 4 week after PCI. Baseline evaluation included demographics and history taking. After obtaining the informed consent, information including age, weight, height, smoking state, and other diseases e.g. hypertension, diabetes, hyperlipidemias, etc. will be documented for each patient. Medication history in detail, as well as the background cardiovascular treatment, will be considered. All patients will be followed up regularly during the hospital stay and after discharge, will be assessed for the occurrence of adverse cardiac events and occurrence of adverse effects from medications
Interventions
DIETARY_SUPPLEMENTAlpha Lipoic Acid plus the standard care for post-PCI MI
Intravenous and oral administration of Alpha Lipoic Acid 600 mg plus the standard care for post-PCI MI which will include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.
DRUGThe standard care for post-PCI MI
will include the required antiplatelet (Dual Antiplatelet Therapy; DAPT), anticoagulants, and anti-ischemic measures (high-intensity statin, ACEI, or aldosterone) as per latest guidelines recommendations.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female or male aged \>18 2. STEMI patients undergoing PCI
Exclusion criteria
1. Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft 2. A late presentation (\>12 h), unsuccessful primary PCI (residual stenosis \>50% in the culprit lesion after procedure) 3. Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI 4. Infectious or inflammatory disease 5. Severe liver or renal disease, (AST or ALT \>3x ULN or Total bilirubin \>2.5 x ULN), (CrCl \< 60 ml/min (based on the Cockroft-Gault equation) 6. Neoplasm, or hematological disorders 7. Pregnant or breast-feeding patients 8. Active participation in another clinical study 9. Patients taking Alpha Lipoic Acid. 10. Systolic Blood pressure \<90
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of No-Reflow phenomena | During 1 week post PCI | To study the effect of Alpha Lipoic Acid administration on the occurrence of No-Reflow phenomena in post-myocardial infarction patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of markers that reflect oxidative stress and inflammation. | Baseline, 24 hours, and 7 days post PCI | Measuring serum concentration of aldehyde dehydrogenase-2 (ALDH2) and paraoxonase-1 (PON-1). ALDH2 reflects oxidative stress, paraoxonase-1 reflects oxidative stress and inflammation. |
| Occurrence of MACE. | up to 4 weeks post PCI. | re-infarction, stroke, cardiovascular hospitalisation, and death. |
| Tolerability of Alpha Lipoic Acid administration | During 4 week post PCI | Occurrence of adverse drug effects |
Countries
Egypt
Outcome results
None listed