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No-Reflow PhenomenonNCT05360602

Alpha Lipoic Acid Effect on No-Reflow Phenomenon

A study of No-Reflow Phenomenon, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
No-Reflow Phenomenon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
1 Jan 2022to 31 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male aged >18
  • STEMI patients undergoing PCI

Who cannot join

  • 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
Show all 10Show fewer
  • Pregnant or breast-feeding patients
  • Active participation in another clinical study
  • Patients taking Alpha Lipoic Acid.
  • Systolic Blood pressure <90

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Ain shams hospitals

    Cairo

Other trials in Egypt

About this study

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

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.

Read the 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

Being tested
Alpha Lipoic Acid plus the standard care for post-PCI MI, The standard care for post-PCI MI
Keywords
No-Reflow Phenomena, Alpha Lipoic Acid, Paraoxonase-1, Aldehyde dehydrogenase-2, Myocardial infarction
Medical subject headings
No-Reflow Phenomenon, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alpha Lipoic Acid plus the standard care for post-PCI MIDietary supplement

    Also called Dietary supplement plus standard care per guidelines 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.

  • The standard care for post-PCI MIDrug

    Also called Guidelines MI management

    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.

Study groups in NCT05360602
Study groupRoleWhat they receive
Control groupExperimental35 STEMI patients undergoing PCI who will receive standard of care 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.
Receives: Drug: The standard care for post-PCI MI
Test groupExperimental35 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 28 days after PCI
Receives: Dietary Supplement: Alpha Lipoic Acid plus the standard care for post-PCI MI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During 1 week post PCI

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, 24 hours, and 7 days post PCI

  2. Occurrence of MACE.

    re-infarction, stroke, cardiovascular hospitalisation, and death.

    Measured: up to 4 weeks post PCI.

  3. Tolerability of Alpha Lipoic Acid administration

    Occurrence of adverse drug effects

    Measured: During 4 week post PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2022
  2. Study start1 Jan 2022
  3. Primary completion1 Jul 2023
  4. Study completion31 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05360602
Sponsor's protocol ID
NRF-123
Status last verified
Nov 2024
First submitted
10 Apr 2022
Last updated
5 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28400034

  • 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.

    PubMed 28616509

  • Kloner RA. No-reflow phenomenon: maintaining vascular integrity. J Cardiovasc Pharmacol Ther. 2011 Sep-Dec;16(3-4):244-50. doi: 10.1177/1074248411405990.

    PubMed 21821523

  • 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.

    PubMed 20488311

  • 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.

    PubMed 19481547

  • 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.

    PubMed 9541487

  • 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.

    PubMed 21843584

Questions about this trial

What is this clinical trial studying?

A study of No-Reflow Phenomenon, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of No-Reflow phenomena (time frame: During 1 week post PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05360602, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.

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