Acute ST-elevation Myocardial Infarction
Conditions
Brief summary
The purpose of this study is to determine whether prolonged inflation time on drug-eluting stents deployment for ST-elevation myocardial Infarction was better than conventional stents deployment.
Interventions
DEVICEdeploying the Drug-eluting Stents with a prolonged time
the inflation time was more than 30 seconds when the Drug-eluting Stents deploying.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system（GuReater）was used in this study
DEVICEdeploying the Drug-eluting Stents with a conventional time
the actual inflation time was within 10s determined by interventional cardiologist.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system（GuReater）was used in this study
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* men and women ≥18 years with ST-elevation Myocardial Infarction; * patients with STEMI and ischemic symptoms of less than 12 hours'duration; * patients with STEMI and ischemic symptoms of less than 12 hours' duration who have contraindications to fibrinolytic therapy, irrespective of the time delay from FMC; * patients with STEMI if there is clinical and/or ECG evidence of ongoing ischemia between 12 and 24 hours after symptom onset; * when angiography was completed, guide wire could cross the lesion in the culprit vessel, TIMI≥1，with feasibility to direct stenting
Exclusion criteria
* cardiac shock, or acute severe heart failure; * the lesion was highly calcified, excessive proximal tortuosity,left main artery lesion, restenosis lesion,vein graft lesion,total occlusions; * True bifurcation lesions; * Stenosis≤50% and TIMI flow grade 3; * history of PCI in target vessel; * diameter of the target vessel less than 2 mm; * severe liver and kidney dysfunction; * inability to give informed written consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| corrected TIMI frame count(frames) | 1 minute after sent was deployed | Grading was done on cinefilm at 15frames/s made in a Philips digital coronary imaging catheterization laboratory. |
| myocardial blush grade | 1 minute after sent was deployed | 0, no myocardial blush or contrast density; 1, minimal myocardial blush or contrast density; 2,moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non- infarct-related coronary artery; and 3, normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery |
| Number of Participants With TIMI 3 | 1 minute after sent was deployed | TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.TIMI 3 is normal flow which fills the distal coronary bed completely |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Target-vessel revascularization | one month after the operation | any revascularization intervention (PCI or CABG) occurring in a treated vessel at any time after the index intervention. |
| Number of Participants had Major bleeding | one month after the operation | any symptomatic intracranial hemorrhage, or clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of\>= g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of\>=15%) |
| Number of Participants stent thrombosis | one month after the operation | evidence of any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death within 30 days after the procedure as stent thrombosis |
| Number of Participants ST-segment resolution | 60min after the operation | 1, normalized, defined as no residual ST-segment elevation; 2, improved, defined as a residual ST-segment elevation ,70% of with that on the first ECG; and 3, unchanged, defined as a residual ST-segment elevation 70% of that on the first ECG |
| Number of Participants Death from cardiac causes | one month after the operation | death from acute myocardial infarction, cardiac perforation, or pericardial tamponade; an arrhythmia or conduction abnormality; complications of the interventional procedure at baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedural time | form start puncturing vascular until the operation was completed intraoperative | minute |
| Radiation exposure time | form start puncturing vascular until the operation was completed intraoperative | minute |
Countries
China
Contacts
Primary ContactHe yong
Outcome results
None listed