Safety and tolerability of sodium thiosulfate in patients presenting with an acute coronary syndrome undergoing coronary angiography via radial approach: a dose-escalation study.

Safety and tolerability of sodium thiosulfate in patients presenting with an acute coronary syndrome undergoing coronary angiography via radial approach: a dose-escalation study. - safe acs

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45347

Enrollment

Registered

2018-02-22

Start date

2017-10-06

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myoacardial infarction

Interventions

the patients will receive STS i.v. in different doses (0, 2.5, 5, and 10 g, 12.5 and 15g

3 patients per dose cohort). STS is administered immediately after arrival at the catheterization laboratory (cath-lab). If hemodynamic stable, a second gift of STS is administered 6 hours after the

acute coronary syndrome

hemodynamic instability

maximum tolerable dose

Sodium thiosulfate

Eligibility

Age

18 Years to 64 Years

Inclusion 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/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.

Exclusion criteria

Exclusion criteria: - Known cardiomyopathy or LVEF

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the development of DLT: All-cause mortality OR hemodynamic instability developed during STS administration, in combination with vasodilators used in radial approach and/or during second infusion after 6 hours. Hemodynamic instability of significant clinical impact is defined as : - Systolic blood pressure 30 min and/or - Catecholamines required to maintain pressure >90 mmHg during systole and - Signs of pulmonary congestion or elevated left-ventricular filling pressures, and - Signs of impaired organ perfusion with *1 of the following criteria: o Confusion; o Cool, clammy skin; o Oliguria (urine output 2.0 mmol/l. - Shock of other causes (hypovolemia, sepsis, bradycardia) are ruled out.	—

Measure

Time frame

Primary endpoint is the development of DLT: All-cause mortality OR hemodynamic instability developed during STS administration, in combination with vasodilators used in radial approach and/or during second infusion after 6 hours. Hemodynamic instability of significant clinical impact is defined as : - Systolic blood pressure 30 min and/or - Catecholamines required to maintain pressure >90 mmHg during systole and - Signs of pulmonary congestion or elevated left-ventricular filling pressures, and - Signs of impaired organ perfusion with *1 of the following criteria: o Confusion; o Cool, clammy skin; o Oliguria (urine output 2.0 mmol/l. - Shock of other causes (hypovolemia, sepsis, bradycardia) are ruled out.

—

Secondary

Measure	Time frame
The effect of STS on: - the development of anaphylaxis; - Nausea/vomiting; - Oxidative stress markers	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)