Sodium Thiosulfate to Preserve Cardiac Function in STEMI

• Status: Active, not recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Age ≥ 18 years;

• The diagnosis STEMI defined by (1.) chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and (2.) an electrocardiogram (ECG) recording with ST- segment elevation of more than 0.1 millivolt (mV) in 2 or more contiguous leads or presence of new left bundle branch block;

• Symptoms and/or ST-segment deviation should be present (persisting) at time of arrival in the cath-lab;

• Primary PCI is being considered as treatment;

• Patient is willing to cooperate with follow-up during 2 years.

Exclusion Criteria:

• Prior MI (STEMI/non-STEMI/acute coronary syndrome (ACS), unless maximum troponin T < 50ng/L.

• Prior CABG;

• Prior PCI, complicated by periprocedural infarction, unless maximum troponin T < 50 ng/L;

• Known cardiomyopathy;

• Previous hospitalization for heart failure;

• Active malignancy (requiring chemotherapy, radiation or surgery at the time of randomization), except for adequately treated non-melanoma skin cancer or other noninvasive or in situ neoplasm (e.g., cervical cancer in situ);

• History of chemotherapy;

• History of radiotherapy in chest region;

• Relieve of symptoms and complete ST-segment resolution prior to arrival at the cath-lab;

• Known permanent atrial fibrillation;

• Presentation with cardiogenic shock (systolic blood pressure <90 mmHg);

• Severe hypertension (systolic blood pressure >220 mmHg);

• Sedated and/or intubated patients;

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

• Contraindication for 3 Tesla (T) CMR-imaging (e.g. body weight >150kg; known claustrophobia; 3 T magnetic resonance imaging (MRI) incompatible ferromagnetic objects in the body, end-stage renal disease);

• Pregnancy or breastfeeding women; women of childbearing potential with clinical suspicion of possible pregnancy;

• 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.

• Contraindication for metoclopramide (e.g. Parkison; epilepsy)