Safety and tolerability of sodium thiosulfate in patients presenting with an acute coronary syndrome undergoing coronary angiography via radial approach: a dose-escalation study.
- Conditions
- myoacardial infarctionheart attack10028593
- Registration Number
- NL-OMON45347
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
- 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/iAP) an electrocardiogram (ECG) recording with ST- segment elevation of more than 0.1 mV in 2 or more contiguous leads;
-cardiac catheterization via radial approach is being considered;
- Patient is willing to cooperate with the trial during hospitalization.
- Known cardiomyopathy or LVEF < 35%;
- History of a malignancy treated with chemo- and/or radiotherapy < 1 year;
- Systolic blood pressure under 100mmHg or over 180mmHg at presentation;
- Cardiogenic shock at presentation? (def: SHOCK II)
- Sedated and/or intubated patients;
- The existence of a condition with a life expectancy of less than 1 year;
- pregnant or breastfeeding at time of presentation;
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is the development of DLT:<br /><br>All-cause mortality OR hemodynamic instability developed during STS<br /><br>administration, in combination with vasodilators used in radial approach and/or<br /><br>during second infusion after 6 hours. Hemodynamic instability of significant<br /><br>clinical impact is defined as :<br /><br>- Systolic blood pressure <90mmHg for >30 min and/or<br /><br>- Catecholamines required to maintain pressure >90 mmHg during systole and<br /><br>- Signs of pulmonary congestion or elevated left-ventricular filling pressures,<br /><br>and<br /><br>- Signs of impaired organ perfusion with *1 of the following criteria:<br /><br>o Confusion;<br /><br>o Cool, clammy skin;<br /><br>o Oliguria (urine output <30 ml/h);<br /><br>o Serum-lactate >2.0 mmol/l.<br /><br>- Shock of other causes (hypovolemia, sepsis, bradycardia) are ruled out. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The effect of STS on:<br /><br>- the development of anaphylaxis;<br /><br>- Nausea/vomiting;<br /><br>- Oxidative stress markers</p><br>