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

July 4, 2017 updated by: Yong He, West China Hospital

the Effect of Prolonged Inflation Time During Drug-eluting Stents Deployment Compared With Conventional Method for ST-elevation Myocardial Infarction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 621000
        • Recruiting
        • West China Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 minute after sent was deployed
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.
1 minute after sent was deployed
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
1 minute after sent was deployed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
60min after the operation
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
one month after the operation
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.
one month after the operation
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
one month after the operation
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%)
one month after the operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural time
Time Frame: form start puncturing vascular until the operation was completed intraoperative
minute
form start puncturing vascular until the operation was completed intraoperative
Radiation exposure time
Time Frame: form start puncturing vascular until the operation was completed intraoperative
minute
form start puncturing vascular until the operation was completed intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Study Director: He yong, west china hospital of sichuan univercity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

December 10, 2016

First Submitted That Met QC Criteria

June 23, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaH-CVD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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