the Effect of Prolonged Inflation Time During Stents Deployment for ST-elevation Myocardial Infarction

Not Applicable

• Conditions: Acute ST-elevation Myocardial Infarction
• Interventions: Device: deploying the Drug-eluting Stents with a conventional time; Device: deploying the Drug-eluting Stents with a prolonged time

• Registration Number: NCT03199014
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-10
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-26
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rapid deployment strategy group	deploying the Drug-eluting Stents with a conventional time	in "deploying the Drug-eluting Stents with a conventional time" group, a conventional method was used to deploying drug-eluting stents,the actual inflation time was within 10s determined by interventional cardiologist.
prolonged deployment strategy group	deploying the Drug-eluting Stents with a prolonged time	in "deploying the Drug-eluting Stents with a prolonged time" group,the inflation time was more than 30 seconds when the Drug-eluting Stents deploying,unless the patients was unstable.

Primary Outcome Measures

Name	Time	Method
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.
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
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

Secondary Outcome Measures

Name	Time	Method
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
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 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 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 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.

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China