Combined Antioxidant Therapy Against Myocardial Reperfusion Injury. Phase I Study.

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

Background: Acute myocardial infarction (AMI) has remained a leading cause of mortality and disability worldwide. Although percutaneous coronary angioplasty (PCA) is the best treatment for these patients, paradoxically this procedure causes reperfusion injury. Considerable efforts aimed to reduce this damage have been made, but the results are disappointing and there is still no effective therapy for preventing the damage. Previously, our team has achieved a reduction of infarct size in an acute myocardial infarction model of isolated rat heart through a synergistic effect of three compounds in a combined antioxidant therapy (CAT).

In this study, we aim to describe the pharmacokinetics and safety of CAT intravenously administered to healthy subjects. This is the first step to a later clinical application of CAT in AMI patients.

Methodology: The safety and pharmacokinetics of the CAT (deferoxamine, N-acetylcysteine, and ascorbate) will be assessed in healthy volunteers in a "phase I clinical trial". Subjects (18-30 years old, n=18) will be randomized 2:1 to receive CAT or placebo over 60 minutes. Blood concentrations of each CAT component will be measured in plasma at 0, 15, 30, 60, 90, 120, and 180 minutes after the infusion onset. Adverse reactions will be registered from the onset of infusion until day 7.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chile
• Collaborator: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
• Treatments: Acetylcysteine; Antioxidants; Deferoxamine

Criteria

Inclusion Criteria:

• Healthy subjects from 18 to 35 years old

• Normal BMI (19-24.9 kg/m2)

Exclusion Criteria:

• Impaired renal function (creatinine > 1.5 mg/dL)

• Liver impairment (liver enzymes over normal values)

• Glucosa 6-phosphate deshidrogenase deficency

• Any chronic disease

• Any acute disease in the last two weeks

• To be enrolled in other clinical study