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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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