STEMI - ST Elevation Myocardial Infarction
Conditions
Keywords
STEMI, Spontaneous Reperfusion, Primary Percutaneous Coronary Intervention, Infarct-Related Artery, TIMI Flow, Venous Stasis, Noninvasive Artificial Venous Stasis, RE-START Procedure, Coronary Reperfusion
Brief summary
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.
Detailed description
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?
Interventions
None listed
Sponsors
Firat University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMEHMET BALIN, MD,PROFFESOR
CONTACTERKAN ÇEÇEN, MD
PRINCIPAL_INVESTIGATORMEHMET BALIN
Firat University
Outcome results
None listed