ST-elevation myocardial infarction(STEMI). ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Conditions
Interventions
Intervention 1: Intervention group:Deflated Balloon-Facilitated Direct Stenting method. Intervention 2: Intervention group:Predilation with balloon angioplasty.
Sponsors
Rasht University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years and older, diagnosed with STEMI in the emergency department, having full criteria for primary PCI, and having informed consent
Exclusion criteria
Exclusion criteria: Cardiogenic shock, complete AV block, severe renal failure (serum creatinine > 3 mg/dL), need for emergency coronary artery bypass graft surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No-reflow phenomenon is referred to as the absence of blood flow after coronary artery re-opening. Variable measurement method: Based on angiographic criteria TIMI flow grade and TIMI frame count. TIMI Flow grade is as follows: Grade 0: No forward blood flow after the occlusion site. Grade 1: Poor forward coronary flow after the occlusion site and incomplete filling of the distal coronary bed.Grade 2: Partial blood flow Grade 3: Complete filling of the distal vessels following ventricular contraction. Timepoint: Before and immediately after primary angioplasty. Method of measurement: TIMI frame count (TFC) is assessed with coronary angiography and frames are numbered and counted to calculate the value, the first frame is defined as the frame in which more than 70% of the coronary artery lumen is filled with contrast material and the last frame is the frame in which the contrast material has reached the coronary end marker.The corrected TIMI frame count (TFC) is calculated by dividing the TFC of the left anterior descending artery by 1.7 . Normal TIMI frame count for the left anterior descending artery (LAD): 36 ± 3 (20 ± 3 for corrected TFC) for the left circumflex artery: 22 ± 4 for the right coronary artery: 20 ± 3.;ST-segment resolution (STR) is considered to be STR if the ST segment has returned to the isoelectric line by more than 70% 90 minutes after injection. Variable measurement method: All patients will have a standard 12-lead ECG at the beginning of their hospital stay and 90 minutes after PPCI. Timepoint: Before the intervention and 90 minutes after the intervention. Method of measurement: The total ST-segment elevation will be recorded 20 ms after the J point in all leads. After the total ST-segment elevation in the leads representing the infarct site on the baseline and 90-minute ECGs is calculated, the STR will be obtained by dividing the second number by the first number and subtracting it from 100, which will be expressed as a percentage.;Left ventr | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events (MACE), which in this study is a combination of cardiac death, non-fatal myocardial infarction, any revascularization, and stroke, are defined according to The Academic Research Consortium. Timepoint: Within 90 days after the intervention. Method of measurement: All patients will be followed for MACE for 90 days, either through a clinic visit or via telephone interview. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr.Faezeh Vaziri
Rasht University of Medical Sciences
Outcome results
None listed