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

Primary Purpose

Acute ST-elevation Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
deploying the Drug-eluting Stents with a prolonged time
deploying the Drug-eluting Stents with a conventional time
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ST-elevation Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prolonged deployment strategy group

rapid deployment strategy group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With TIMI 3
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
corrected TIMI frame count(frames)
Grading was done on cinefilm at 15frames/s made in a Philips digital coronary imaging catheterization laboratory.
myocardial blush grade
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

Number of Participants ST-segment resolution
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
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 Target-vessel revascularization
any revascularization intervention (PCI or CABG) occurring in a treated vessel at any time after the index intervention.
Number of Participants stent thrombosis
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
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%)

Full Information

First Posted
December 10, 2016
Last Updated
July 4, 2017
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03199014
Brief Title
the Effect of Prolonged Inflation Time During Stents Deployment for ST-elevation Myocardial Infarction
Official Title
the Effect of Prolonged Inflation Time During Drug-eluting Stents Deployment Compared With Conventional Method for ST-elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ST-elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prolonged deployment strategy group
Arm Type
Experimental
Arm Description
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.
Arm Title
rapid deployment strategy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
deploying the Drug-eluting Stents with a prolonged time
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
deploying the Drug-eluting Stents with a conventional time
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Participants With TIMI 3
Description
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
Time Frame
1 minute after sent was deployed
Title
corrected TIMI frame count(frames)
Description
Grading was done on cinefilm at 15frames/s made in a Philips digital coronary imaging catheterization laboratory.
Time Frame
1 minute after sent was deployed
Title
myocardial blush grade
Description
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
Time Frame
1 minute after sent was deployed
Secondary Outcome Measure Information:
Title
Number of Participants ST-segment resolution
Description
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
Time Frame
60min after the operation
Title
Number of Participants Death from cardiac causes
Description
death from acute myocardial infarction, cardiac perforation, or pericardial tamponade; an arrhythmia or conduction abnormality; complications of the interventional procedure at baseline
Time Frame
one month after the operation
Title
Number of Participants Target-vessel revascularization
Description
any revascularization intervention (PCI or CABG) occurring in a treated vessel at any time after the index intervention.
Time Frame
one month after the operation
Title
Number of Participants stent thrombosis
Description
evidence of any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death within 30 days after the procedure as stent thrombosis
Time Frame
one month after the operation
Title
Number of Participants had Major bleeding
Description
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%)
Time Frame
one month after the operation
Other Pre-specified Outcome Measures:
Title
Procedural time
Description
minute
Time Frame
form start puncturing vascular until the operation was completed intraoperative
Title
Radiation exposure time
Description
minute
Time Frame
form start puncturing vascular until the operation was completed intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He yong
Phone
+8618980602038
Email
zznnyeah@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He yong
Organizational Affiliation
west china hospital of sichuan univercity
Official's Role
Study Director
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
621000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He yong
Phone
+8618980602038
Email
zznnyeah@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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12075259
Citation
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Results Reference
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Citation
Ozdemir R, Sezgin AT, Barutcu I, Topal E, Gullu H, Acikgoz N. Comparison of direct stenting versus conventional stent implantation on blood flow in patients with ST-segment elevation myocardial infarction. Angiology. 2006 Aug-Sep;57(4):453-8. doi: 10.1177/0003319706290620.
Results Reference
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PubMed Identifier
25964649
Citation
Li C, Zhang B, Li M, Liu J, Wang L, Liu Y, Wang Z, Wen S. Comparing Direct Stenting With Conventional Stenting in Patients With Acute Coronary Syndromes: A Meta-Analysis of 12 Clinical Trials. Angiology. 2016 Apr;67(4):317-25. doi: 10.1177/0003319715585662. Epub 2015 May 11.
Results Reference
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PubMed Identifier
22109977
Citation
Hovasse T, Mylotte D, Garot P, Salvatella N, Morice MC, Chevalier B, Pichard A, Lefevre T. Duration of balloon inflation for optimal stent deployment: five seconds is not enough. Catheter Cardiovasc Interv. 2013 Feb;81(3):446-53. doi: 10.1002/ccd.23343. Epub 2012 Jan 10.
Results Reference
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PubMed Identifier
9639373
Citation
van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. doi: 10.1161/01.cir.97.23.2302.
Results Reference
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Citation
Gibson CM, Murphy SA, Rizzo MJ, Ryan KA, Marble SJ, McCabe CH, Cannon CP, Van de Werf F, Braunwald E. Relationship between TIMI frame count and clinical outcomes after thrombolytic administration. Thrombolysis In Myocardial Infarction (TIMI) Study Group. Circulation. 1999 Apr 20;99(15):1945-50. doi: 10.1161/01.cir.99.15.1945.
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Citation
Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. doi: 10.1161/01.cir.93.5.879.
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Ma M, Wang L, Diao KY, Liang SC, Zhu Y, Wang H, Wang M, Zhang L, Yang ZG, He Y. A randomized controlled clinical trial of prolonged balloon inflation during stent deployment strategy in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a pilot study. BMC Cardiovasc Disord. 2022 Feb 4;22(1):30. doi: 10.1186/s12872-022-02477-0.
Results Reference
derived

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