Sodium Thiosulfate to Preserve Cardiac Function in STEMI

Summary

Rationale: Timely and effective reperfusion by primary percutaneous coronary intervention (PPCI) is currently the most effective treatment of ST-segment elevation myocardial infarction (STEMI). However, permanent myocardial injury related to the ischemia and subsequent reperfusion is observed in the vast majority (88%) of patients and harbours a risk of heart failure development. Administration of hydrogen sulfide (H2S) has been shown to protect the heart from "ischemia reperfusion injury" in various experimental models. Data in humans suggests that the H2S-releasing agent sodium thiosulfate (STS) can be administered safely.

Objective: to evaluate the efficacy and safety of STS compared to placebo treatment on myocardial infarct size in patients presenting with STEMI and treated with PCI

Study design: a multicenter, double blind, randomized controlled clinical trial. A total of 380 patients, aged 18 years and above, undergoing primary PCI for a first STEMI and deemed amenable, by the investigator, to be treated with STS 12.5g intravenously (i.v.) or matched placebo immediately after arrival at the catheterization laboratory (cath-lab) and a repeated dose administered 6 hours after the first dose, on top of standard treatment. Primary endpoint is infarct size as measured with cardiac magnetic resonance imaging (CMR-imaging) 4 months after randomization.

Conditions

• Myocardial Infarction
• Heart Failure

Interventions

DRUG

Sodium thiosulfate

see description under experimental arm

DRUG

Sodium chloride 0.9%

see description under placebo comparator arm

PROCEDURE

primary percutaneous coronary intervention

Primary treatment of the ischemia-related coronary artery is left to discretion of the operator and might consist of thrombus aspiration, balloon inflation and stent implantation. Additional balloon angioplasty or stenting of the culprit or other lesions will be performed when necessary.

OTHER

cardiac magnetic resonance imaging

CMR-imaging will be used for assessment of infarct size, left ventricular function, quantification of myocardial scar and diffuse myocardial fibrosis. CMR-imaging examinations will be performed on a 3 Tesla scanner using a phased array cardiac receiver coil at 4 months after randomization according to standard protocols. The full study protocol lasts approximately 45 minutes and includes anatomy and function, LGE and T1-mapping.

Sponsors & Collaborators

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Pim van der Harst, Prof. dr. · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-20

Primary Completion

2021-06-25

Completion

2023-03-31

Countries

• Netherlands

Study Locations