NCT05360602Completed
Alpha Lipoic Acid Effect on No-Reflow Phenomenon
Evaluation of The Effect of Alpha Lipoic Acid Administration on Oxidative Stress Markers and Occurrence of No-Reflow Phenomenon in Post Myocardial Infarction Patients
Source: ClinicalTrials.gov · Last updated 5 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 10 Apr 2022
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Jul 2023
- Lead sponsor
- Ain Shams University
- Diseases
- Coronary artery disease
- NCT number
- NCT05360602
What you commit to
- Study type: Interventional
- Participants enrolled: 70
- From 1 Jan 2022 to the primary completion date, 1 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a recent history of myocardial infarction (MI), a previous PCI or a previous coronary artery bypass graft
- Pretreatment with thrombolytic or glycoprotein IIb/IIIa inhibitor therapy before primary PCI
Other illness
- Infectious or inflammatory disease
- Neoplasm, or hematological disorders
Lab values
- 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)
Other
- A late presentation (\>12 h), unsuccessful primary PCI (residual stenosis \>50% in the culprit lesion after procedure)
- Pregnant or breast-feeding patients
- Active participation in another clinical study
- Patients taking Alpha Lipoic Acid.
- Systolic Blood pressure \<90
Who the study is looking for
- Female or male aged \>18
- STEMI patients undergoing PCI
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ain shams hospitals Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.