Safety and Tolerability of Sodium Thiosulfate in Patients With an ACS Undergoing CAG Via Trans-radial Approach.

• Status: Completed
• Trial end date: 2018-03-23
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the safety and maximum tolerable dose (MTD) of sodium thiosulfate in patients presenting with an acute coronary syndrome and treated with primary percutaneous coronary intervention (PPCI) via trans-radial approach in adjunction to standard treatment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Treatments: Sodium thiosulfate

Criteria

Inclusion Criteria:

• Age ≥ 18 years;

• The diagnosis ACS defined by: chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 24 hours before hospital admission, with (STEMI) or without (nSTEMI/uAP) an electrocardiogram (ECG) recording with ST- segment elevation of more than 0.1 millivolt (mV) in 2 or more contiguous leads;

• PCI via trans-radial approach is being considered as treatment;

• Patient is willing to cooperate with the trial during hospitalization

Exclusion Criteria:

• Known cardiomyopathy or LVEF<35%;

• History of a malignancy treated with chemo- and/or radiotherapy < 1 year;

• Systolic blood pressure under 100 mmHg or over 180 mmHg at presentation;

• Cardiogenic shock at presentation

• Sedated and/or intubated patients;

• Pregnant/breastfeeding at time of presentation

• The existence of a condition with a life expectancy of less than 1 year;

• A condition which, according to the clinical judgment of the investigator and/or treating physician, does not allow the patient to successfully participate in the study.