Noninvasive Artificial Venous Stasis for Reperfusion in STEMI
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirat University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
PeriproceduralSecondary outcomes
1
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 PCI2
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 PCI3
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 first4
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 dischargeSponsors and contacts
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Source ClinicalTrials.gov