This prospective, randomized study was designed to evaluate whether the noninvasive artificial venous stasis / RE-START procedure, administered prior to primary percutaneous coronary intervention, increases the frequency of spontaneous coronary reperfusion in the infarct-related artery.
The primary hypothesis of the study is that the application of short-term, controlled venous return restriction via a blood pressure cuff on the non-dominant arm may support thrombus lysis by stimulating endothelial-derived fibrinolytic activity and may increase the rate of spontaneous reperfusion, defined as TIMI 2 or TIMI 3 flow, in the infarct-related artery prior to primary percutaneous coronary intervention. This study seeks to answer the following key question: In patients with acute STEMI, does the RE-START procedure-administered without delaying standard care or the preparation process for primary percutaneous coronary intervention-increase the incidence of spontaneous coronary reperfusion prior to primary percutaneous coronary intervention compared to a sham/control procedure?
Study Type
OBSERVATIONAL
Enrollment
500
Firat University
Elâzığ, Elaziğ, Turkey (Türkiye)
RECRUITINGFirat University
Elâzığ, Merkez, Turkey (Türkiye)
RECRUITINGPresence of Spontaneous Coronary Reperfusion Before Primary PCI
Spontaneous coronary reperfusion will be defined as the presence of TIMI flow grade 2 or 3 in the infarct-related artery on the first diagnostic coronary angiography performed before guidewire crossing and before primary percutaneous coronary intervention
Time frame: Periprocedural
ST-Segment Resolution After Primary PCI
ST-segment resolution will be assessed by comparing the baseline electrocardiogram with the electrocardiogram obtained after primary percutaneous coronary intervention. ST-segment resolution will be calculated based on the change in ST-segment elevation in the lead with the highest baseline ST elevation.
Time frame: 90 minutes after primary PCI
Left Ventricular Ejection Fraction
Left ventricular ejection fraction will be measured by echocardiography. The post-procedural left ventricular ejection fraction value will be used for outcome assessment.
Time frame: Within 48 hours after primary PCI
Peak-to-Baseline D-Dimer Ratio Through Day 3
The peak-to-baseline D-dimer ratio will be calculated by dividing the highest D-dimer level measured from baseline through Day 3, or until hospital discharge if discharge occurs earlier, by the baseline D-dimer level.
Time frame: From baseline to Day 3 or hospital discharge, whichever occurs first
NT-proBNP Level at Hospital Discharge
NT-proBNP level will be measured at hospital discharge and compared between the study groups
Time frame: At hospital discharge
Contrast-Associated Acute Kidney Injury
Contrast-associated acute kidney injury will be defined as an increase in serum creatinine level of at least 0.3 mg/dL or at least 50% from baseline after primary percutaneous coronary intervention. Serum creatinine levels will be assessed at baseline and during hospitalization.
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Time frame: From baseline to 48-72 hours after primary PCI