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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female or male aged >18 and < 75 years
  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.

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

    First Posted
    April 10, 2022
    Last Updated
    April 29, 2022
    Sponsor
    Ain Shams University
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    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
    background
    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
    background

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