Myocardial Infarction
Conditions
Brief summary
No consensus exists about which coronary artery should be firstly catheterized in primary percutaneous coronary intervention (PCI). The aim of the present study was to compare door-to-balloon time (D2B) of ECG guided immediate infarct-related artery (IRA) PCI with traditional complete coronary angiography followed by PCI for the treatment of ST segment elevation myocardial infarction (STEMI) patients. Primary endpoint is door to device (D2D) time. Secondary end-points are: puncture to device (P2D) time,first medical contact to device (FMC2D) time,incidence of radial artery spasm and occlusion, contrast amount, fluoroscopy time, cumulative air kerma(CAK) and dose area product(DAP).
Interventions
PROCEDUREculprit vessel intervention
ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5
PROCEDUREtraditional approach
single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI
Sponsors
Beijing Luhe Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be \> 18 years of age * Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation≥2mm in two continuous precordial leads or ST elevations≥1mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI * Symptoms ≥ 30 min and ≤12 hours * Patient and treating interventional cardiologist agree for randomization * Patient provides written informed consent * Diagnostic and therapeutic intervention performed through transradial artery approach * Palpable radial artery.
Exclusion criteria
* Concurrent participation in other investigational study * Current platelet count \<100 x 10\^9cells/L or Hgb \<10 g/dL * Absence of radial artery pulsation * Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy * Uncontrolled hypertension * Prior CABG surgery * Fibrinolytic therapy for current MI treatment * patient have a life expectancy of \<180days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| door to device (D2D) time | 24hours | time patient's arrival at our hospital to first device (balloon,aspiration catheter or stent) use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| puncture to device (P2D) time | 24hours | time from radail artery puncture to first device(balloon,aspiration catheter or stent) use |
| first medical contact to device (FMC2D) time | 24hours | time from first medical contact to first device (balloon,aspiration catheter or stent) use. |
| incidence of radial artery spasm | during the procedure (time from the guide catheter inserted to guide catheter removed) | radial artery spasms were defined as follows. Severe, moderate, and mild based on radiao angiography before and after procedure |
| fluoroscopy time | 1 hour | recorded on the machine |
| cumulative air kerma(CAK) and dose area product(DAP). | 1 hour | recorded on the machine |
| incidence of radial artery occlusion | inhospital (an expected average of 5 days),30day,12month | the absence of palpable radial artery pulsation confirmed by echocardiogram |
Other
| Measure | Time frame | Description |
|---|---|---|
| MACE | 12 month | major advance cardiac event (MACE)including cardiacdeath, myocardial infarction (MI) and target vessel revascularization (TVR) |
Countries
China
Outcome results
None listed