Noninvasive Artificial Venous Stasis for Reperfusion in STEMI

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?

Primary outcomes

• Presence of Spontaneous Coronary Reperfusion Before Primary PCI [Periprocedural]: 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

Secondary outcomes

• ST-Segment Resolution After Primary PCI [90 minutes 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.
• Left Ventricular Ejection Fraction [Within 48 hours after primary PCI]: Left ventricular ejection fraction will be measured by echocardiography. The post-procedural left ventricular ejection fraction value will be used for outcome assessment.
• Peak-to-Baseline D-Dimer Ratio Through Day 3 [From baseline to Day 3 or hospital discharge, whichever occurs first]: 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.
• NT-proBNP Level at Hospital Discharge [At hospital discharge]: NT-proBNP level will be measured at hospital discharge and compared between the study groups
• Contrast-Associated Acute Kidney Injury [From baseline to 48-72 hours after primary PCI]: 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.

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

* Having presented within the first 12 hours of symptom onset Being hemodynamically stable (Killip Class I-II)

  * STEMI diagnosis confirmed by coronary angiography
  * Primary PCI (percutaneous coronary intervention) scheduled
  * No pathology in the upper extremity that would prevent cuff application
  * Be capable of providing informed consent and provide consent

Exclusion Criteria:

* Presence of cardiogenic shock (systolic blood pressure < 90 mmHg and Killip Class III-IV)

  * Cardiac arrest occurring before or after the procedure
  * Need for resuscitation following failed thrombolysis
  * History of prior coronary artery bypass surgery
  * Concurrent acute aortic dissection
  * Venous thromboembolism or pulmonary embolism
  * History of an acute infection within the past 7 days
  * Chronic kidney disease requiring erythropoietin therapy or currently undergoing hemodialysis
  * Presence of liver failure or a hematologic disorder
  * Presence of any chronic inflammatory or autoimmune disease
  * History of any known malignancy (cancer)
  * Current treatment with glibenclamide, corticosteroids, antioxidant vitamins, or cyclosporine at the time of enrollment
  * History of chronic (daily) alcohol consumption
  * Contraindications to aspirin and/or clopidogrel
  * Failure to confirm a STEMI diagnosis via coronary angiography
  * Inability to provide informed consent
  * Pregnancy
  * First 6 months postpartum Conditions in which the administration of thrombolytics is contraindicated

• MEHMET BALIN, Principal investigator, Firat University