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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199014
Recruitment Status : Unknown
Verified July 2017 by Yong He, West China Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Yong He, West China Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute ST-elevation Myocardial Infarction Device: deploying the Drug-eluting Stents with a prolonged time Device: deploying the Drug-eluting Stents with a conventional time Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: the Effect of Prolonged Inflation Time During Drug-eluting Stents Deployment Compared With Conventional Method for ST-elevation Myocardial Infarction
Actual Study Start Date : December 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: prolonged deployment strategy group
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.
 Device: deploying 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
Active Comparator: rapid deployment strategy group
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.
 Device: deploying 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With TIMI 3 [ Time Frame: 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

  2. corrected TIMI frame count(frames) [ Time Frame: 1 minute after sent was deployed ]
    Grading was done on cinefilm at 15frames/s made in a Philips digital coronary imaging catheterization laboratory.

  3. myocardial blush grade [ Time Frame: 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 :
  1. Number of Participants ST-segment resolution [ Time Frame: 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

  2. Number of Participants Death from cardiac causes [ Time Frame: 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

  3. Number of Participants Target-vessel revascularization [ Time Frame: one month after the operation ]
    any revascularization intervention (PCI or CABG) occurring in a treated vessel at any time after the index intervention.

  4. Number of Participants stent thrombosis [ Time Frame: 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

  5. Number of Participants had Major bleeding [ Time Frame: 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%)


Other Outcome Measures:
  1. Procedural time [ Time Frame: form start puncturing vascular until the operation was completed intraoperative ]
    minute

  2. Radiation exposure time [ Time Frame: form start puncturing vascular until the operation was completed intraoperative ]
    minute


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199014


Contacts
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Contact: He yong +8618980602038 zznnyeah@163.com

Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 621000
Contact: He yong    +8618980602038    zznnyeah@163.com   
Sponsors and Collaborators
West China Hospital
Investigators
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Study Director: He yong west china hospital of sichuan univercity
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yong He, Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03199014    
Other Study ID Numbers: WestChinaH-CVD-001
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases