Groningen Intervention study for the Preservation of cardiac function with sodium thiosulfate after ST-segment elevation myocardial infarctio

Phase 2

Completed

• Conditions: myoacardial infarction; heart attack; 10028593

• Registration Number: NL-OMON47742
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 380

Inclusion Criteria

1. Age * 18 years;, 2. 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 recording with ST- segment elevation of more than 0.1 mV in 2
or more contiguous leads or presence of new left bundle branch block;;, 3.
Symptoms and/or ST-segment deviation should be present (persisting) at time of
arrival in the catheterization laboratory;, 4. Primary percutaneous
intervention is being considered as treatment;, 5. Patient is willing to
cooperate with follow-up during 2 years.

Exclusion Criteria

1. Prior myocardial infarction, unless maximum troponin T< 50 ng/L
(STEMI/non-STEMI/acute coronary syndrome);
2. Known permanent atrial fibrillation;
3. Prior CABG;
4. Prior PCI, complicated by periprocedural infarction, unless maximum troponin
T < 50ng/L;
5. Known cardiomyopathy;
6. Previous hospitalization for heart failure
7. 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);
8. History of chemotherapy;
9. History of radiotherapy in chest region;
10. Relieve of symptoms and complete ST-segment resolution prior to arrival at
the catheterization laboratory;
11. Presentation with cardiogenic shock (systolic blood pressure < 90 mmHg);
12. Severe hypertension (systolic blood pressure > 220 mmHg);
13. Sedated and/or intubated patients;
14. The existence of a condition with a life expectancy of less than 1 year;
15. Contraindication for 3 Tesla (T) CMR-imaging (e.g. body weight >;150kg;
known claustrophobia; 3T MRI incompatible ferromagnetic objects in the body,
end-stage renal disease);
16. Pregnancy or breastfeeding women; women of childbearing potential with
clinical suspicion of possible pregnancy;
17. 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 infarct size as measured with cardiac magnetic resonance<br /><br>imaging (CMR-imaging) 4 months after randomization. </p><br>