Alpha Lipoic Acid Effect on No-Reflow Phenomenon
Primary Purpose
No-Reflow Phenomenon
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alpha Lipoic Acid plus the standard care for post-PCI MI
The standard care for post-PCI MI
Sponsored by
About this trial
This is an interventional prevention trial for No-Reflow Phenomenon focused on measuring No-Reflow Phenomena, Alpha Lipoic Acid, Paraoxonase-1, Aldehyde dehydrogenase-2, Myocardial infarction
Eligibility Criteria
Inclusion Criteria:
- Female or male aged >18 and < 75 years
- STEMI patients undergoing PCI
Exclusion Criteria:
- Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft
- A late presentation (>12 h), unsuccessful primary PCI (residual stenosis >50% in the culprit lesion after procedure)
- Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI
- Infectious or inflammatory disease
- 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)
- Neoplasm, or hematological disorders
- Pregnant or breast-feeding patients
- Active participation in another clinical study
- Patients taking Alpha Lipoic Acid.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group
Test group
Arm Description
30 STEMI patients undergoing PCI who will receive standard of care for 1 week that 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.
30 STEMI patients undergoing PCI who will receive the standard of care in addition to IV Alpha Lipoic Acid 600 mg before PCI then 600 mg orally for 1 week after PCI
Outcomes
Primary Outcome Measures
Occurrence of No-Reflow phenomena
To study the effect of Alpha Lipoic Acid administration on the occurrence of No-Reflow phenomena in post-myocardial infarction patients
Secondary Outcome Measures
Evaluation of markers that reflect oxidative stress and inflammation.
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.
re-infarction, stroke, cardiovascular hospitalisation, and death.
Tolerability of Alpha Lipoic Acid administration
Occurrence of adverse drug effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05360602
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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 (60) STEMI patients undergoing PCI presenting to the Cardiology department will be randomly assigned into one of 2 arms: 30 patients undergoing PCI who will receive standard of care for 1 week, the other 30 patients undergoing PCI will receive standard of care in addition to Alpha Lipoic Acid 600 mg daily for 1 week. IV Alpha Lipoic Acid 600 mg once daily will be administered prior to PCI then orally daily for 1 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
No-Reflow Phenomenon
Keywords
No-Reflow Phenomena, Alpha Lipoic Acid, Paraoxonase-1, Aldehyde dehydrogenase-2, Myocardial infarction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm Description
30 STEMI patients undergoing PCI who will receive standard of care for 1 week that 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.
Arm Title
Test group
Arm Type
Experimental
Arm Description
30 STEMI patients undergoing PCI who will receive the standard of care in addition to IV Alpha Lipoic Acid 600 mg before PCI then 600 mg orally for 1 week after PCI
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha Lipoic Acid plus the standard care for post-PCI MI
Other Intervention Name(s)
Dietary supplement plus standard care per guidelines for post-PCI MI
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
The standard care for post-PCI MI
Other Intervention Name(s)
Guidelines MI management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of No-Reflow phenomena
Description
To study the effect of Alpha Lipoic Acid administration on the occurrence of No-Reflow phenomena in post-myocardial infarction patients
Time Frame
During 1 week post PCI
Secondary Outcome Measure Information:
Title
Evaluation of markers that reflect oxidative stress and inflammation.
Description
Measuring serum concentration of aldehyde dehydrogenase-2 (ALDH2) and paraoxonase-1 (PON-1). ALDH2 reflects oxidative stress, paraoxonase-1 reflects oxidative stress and inflammation.
Time Frame
Baseline and Day 7 post PCI
Title
Occurrence of MACE.
Description
re-infarction, stroke, cardiovascular hospitalisation, and death.
Time Frame
up to 4 weeks post PCI.
Title
Tolerability of Alpha Lipoic Acid administration
Description
Occurrence of adverse drug effects
Time Frame
During 1 week post PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female or male aged >18 and < 75 years
STEMI patients undergoing PCI
Exclusion Criteria:
Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft
A late presentation (>12 h), unsuccessful primary PCI (residual stenosis >50% in the culprit lesion after procedure)
Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI
Infectious or inflammatory disease
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)
Neoplasm, or hematological disorders
Pregnant or breast-feeding patients
Active participation in another clinical study
Patients taking Alpha Lipoic Acid.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Ragab Elsayed, BSc
Phone
00201011177942
Email
omar.ragab@pharma.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Lamiaa M El Wakeel, PhD
Phone
00201005201099
Email
lamywak@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman M Saleh, MD
Organizational Affiliation
Faculty of Medicine, Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lamiaa M El Wakeel, PhD
Organizational Affiliation
Faculty of Pharmacy, Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marwa Adel Ahmed, PhD
Organizational Affiliation
Faculty of Pharmacy, Ain Shams University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28400034
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.
Results Reference
background
PubMed Identifier
28616509
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.
Results Reference
background
PubMed Identifier
21821523
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.
Results Reference
background
PubMed Identifier
20488311
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.
Results Reference
background
PubMed Identifier
19481547
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. Erratum In: J Mol Cell Cardiol. 2009 Nov;47(5):748.
Results Reference
background
PubMed Identifier
9541487
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.
Results Reference
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PubMed Identifier
21843584
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.
Results Reference
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Alpha Lipoic Acid Effect on No-Reflow Phenomenon
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