Clinical trial NCT05360602: Alpha Lipoic Acid Effect on No-Reflow Phenomenon
Official title: Evaluation of The Effect of Alpha Lipoic Acid Administration on Oxidative Stress Markers and Occurrence of No-Reflow Phenomenon in Post Myocardial Infarction Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No-Reflow Phenomenon
Keywords: No-Reflow Phenomena
Alpha Lipoic Acid
Paraoxonase-1
Aldehyde dehydrogenase-2
Myocardial infarction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of No-Reflow phenomena
timeFrame: During 1 week post PCI
Secondary outcomes:
measure: Evaluation of markers that reflect oxidative stress and inflammation.
timeFrame: Baseline, 24 hours, and 7 days post PCI
measure: Occurrence of MACE.
timeFrame: up to 4 weeks post PCI.
measure: Tolerability of Alpha Lipoic Acid administration
timeFrame: During 4 week post PCI
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams hospitals
Study officials:
affiliation: Faculty of Medicine, Ain Shams University
name: Ayman M Saleh, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Ain Shams University
name: Lamiaa M El Wakeel, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Ain Shams University
name: Marwa Adel Ahmed, PhD
role: STUDY_DIRECTOR
References:
citation: Choudhary S. Association of syntax score with short-term outcomes among acute ST-elevation myocardial infarction patients undergoing primary PCI. Indian Heart J. 2017 Apr;69 Suppl 1(Suppl 1):S20-S23. doi: 10.1016/j.ihj.2016.08.002. Epub 2016 Aug 24.
citation: Mazhar J, Mashicharan M, Farshid A. Predictors and outcome of no-reflow post primary percutaneous coronary intervention for ST elevation myocardial infarction. Int J Cardiol Heart Vasc. 2015 Nov 6;10:8-12. doi: 10.1016/j.ijcha.2015.11.002. eCollection 2016 Mar.
citation: Kloner RA. No-reflow phenomenon: maintaining vascular integrity. J Cardiovasc Pharmacol Ther. 2011 Sep-Dec;16(3-4):244-50. doi: 10.1177/1074248411405990.
citation: Ndrepepa G, Tiroch K, Fusaro M, Keta D, Seyfarth M, Byrne RA, Pache J, Alger P, Mehilli J, Schomig A, Kastrati A. 5-year prognostic value of no-reflow phenomenon after percutaneous coronary intervention in patients with acute myocardial infarction. J Am Coll Cardiol. 2010 May 25;55(21):2383-9. doi: 10.1016/j.jacc.2009.12.054.
citation: Fearon IM, Faux SP. Oxidative stress and cardiovascular disease: novel tools give (free) radical insight. J Mol Cell Cardiol. 2009 Sep;47(3):372-81. doi: 10.1016/j.yjmcc.2009.05.013. Epub 2009 May 28.
citation: Aviram M, Rosenblat M, Bisgaier CL, Newton RS, Primo-Parmo SL, La Du BN. Paraoxonase inhibits high-density lipoprotein oxidation and preserves its functions. A possible peroxidative role for paraoxonase. J Clin Invest. 1998 Apr 15;101(8):1581-90. doi: 10.1172/JCI1649.
citation: Wang X, Yu Y, Ji L, Liang X, Zhang T, Hai CX. Alpha-lipoic acid protects against myocardial ischemia/reperfusion injury via multiple target effects. Food Chem Toxicol. 2011 Nov;49(11):2750-7. doi: 10.1016/j.fct.2011.07.065. Epub 2011 Aug 6.