Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Presence 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 | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 minutes after primary PCI |
Not provided
Inclusion Criteria:
Having presented within the first 12 hours of symptom onset Being hemodynamically stable (Killip Class I-II)
Exclusion Criteria:
Presence of cardiogenic shock (systolic blood pressure < 90 mmHg and Killip Class III-IV)
Not provided
Not provided
The study population will include adult patients admitted to Firat University Hospital with acute ST-segment elevation myocardial infarction who are eligible for and planned to undergo primary percutaneous coronary intervention. Eligible patients will be randomized before coronary angiography to either the RE-START procedure group or the sham-control group, without delaying standard STEMI management or primary PCI.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MEHMET BALIN, MD,PROFFESOR | Contact | +905059174185 | +905301178284 | mehmetbalina@yahoo.com |
| ERKAN ÇEÇEN, MD | Contact | +905301178284 | +905301178284 | drerkancecen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| MEHMET BALIN | Firat University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Firat University | Recruiting | Elâzığ | Elaziğ | 23000 | Turkey (Türkiye) |
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Araştırma katılımcılarından alınan materyal örneklerinin bir biyolojik örneği saklanmayacaktır.
| 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. | 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. | 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 | 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. | From baseline to 48-72 hours after primary PCI |
| Firat University | Recruiting | Elâzığ | Merkez | 23000 | Turkey (Türkiye) |
|
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D014648 | Varicose Veins |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |