Alpha Lipoic Acid Effect on No-Reflow Phenomenon

April 29, 2022 updated by: Omar Ragab, Ain Shams University

Evaluation of The Effect of Alpha Lipoic Acid Administration on Oxidative Stress Markers and Occurrence of No-Reflow Phenomenon in Post Myocardial Infarction Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lamiaa M El Wakeel, PhD
  • Phone Number: 00201005201099
  • Email: lamywak@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control group
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.
Drug: The 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.
Other Names:
  • Guidelines MI management
Experimental: Test group
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
Dietary supplement: Alpha 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.
Other Names:
  • Dietary supplement plus standard care per guidelines for post-PCI MI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of No-Reflow phenomena
Time Frame: 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
During 1 week post PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of markers that reflect oxidative stress and inflammation.
Time Frame: Baseline and Day 7 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.
Baseline and Day 7 post PCI
Occurrence of MACE.
Time Frame: up to 4 weeks post PCI.
re-infarction, stroke, cardiovascular hospitalisation, and death.
up to 4 weeks post PCI.
Tolerability of Alpha Lipoic Acid administration
Time Frame: During 1 week post PCI
Occurrence of adverse drug effects
During 1 week post PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Ayman M Saleh, MD, Faculty of Medicine, Ain Shams University
  • Study Director: Lamiaa M El Wakeel, PhD, Faculty of Pharmacy, Ain Shams University
  • Study Director: Marwa Adel Ahmed, PhD, Faculty of Pharmacy, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

April 10, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRF-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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