Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI (NOSLOWFLOW-Ⅰ)

January 19, 2018 updated by: Chunguang Qiu, The First Affiliated Hospital of Zhengzhou University

Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction

Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following PPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during PPCI.

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.
1000

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.
  • Name: Chunguang Qiu, Phd
  • Phone Number: +86-13803898806
  • Email: qcg123@163.com

Study Contact Backup

Study Locations

  • China
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • Anyang District Hospital
      • Jiaozuo, Henan, China, 454000
        • Recruiting
        • The 99th Central Hospital of the People's Liberation Army
      • Jiaozuo, Henan, China, 454002
        • Recruiting
        • The People's Hospital of Jiaozuo
      • Jiyuan, Henan, China, 454000
        • Recruiting
        • The second people's Hospital of Jiyuan
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Huaihe Hospital of Henan University
      • Kaifeng, Henan, China, 475000
        • Recruiting
        • Kaifeng Central Hospital
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Lushan, Henan, China, 467300
        • Recruiting
        • Lushan People's Hospital
      • Nanyang, Henan, China, 473000
        • Recruiting
        • Nanyang City Center Hospital
      • Pingdingshan, Henan, China, 467000
        • Recruiting
        • Pingmei Shenma medical group general hospital
      • Pingdingshan, Henan, China, 467000
        • Recruiting
        • The Second People's Hospital of Pingdingshan
      • Puyang, Henan, China, 457000
        • Recruiting
        • Puyang Oilfield General Hospital
      • Puyang, Henan, China, 457099
        • Recruiting
        • Puyang People's Hospital
      • Sanmenxia, Henan, China, 472000
        • Recruiting
        • Yellow River Sanmenxia Hospital
      • Shangqiu, Henan, China, 476000
        • Recruiting
        • The First People's Hospital of Shangqiu
      • Xinxiang, Henan, China, 453100
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
      • Xinyang, Henan, China, 464000
        • Recruiting
        • Xinyang Central Hospital
      • Yanshi, Henan, China, 471900
        • Recruiting
        • Yanshi People's Hospital
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Chunguang Qiu, Phd
      • Zhengzhou, Henan, China, 450007
        • Recruiting
        • Zhengzhou Central Hospital
      • Zhengzhou, Henan, China, 450004
        • Recruiting
        • Zhengzhou First People's Hospital
      • Zhengzhou, Henan, China, 450006
        • Recruiting
        • Zhengzhou Cardiovascular Hospital
      • Zhengzhou, Henan, China, 450053
        • Recruiting
        • People's Hospital of Zhengzhou
      • Zhengzhou, Henan, China, 452370
        • Recruiting
        • The First People'S Hospital of Xinmi
      • Zhoukou, Henan, China, 466000
        • Recruiting
        • Zhoukou Central Hospital
      • Zhumadian, Henan, China, 463000
        • Recruiting
        • The First People's Hospital of Zhumadian
      • Zhumadian, Henan, China, 463000
        • Recruiting
        • Zhumadian Central Hospital
    • Shanxi
      • Jincheng, Shanxi, China, 048026
        • Recruiting
        • Jincheng People's Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ischemic symptoms < 12h, or evidence of ongoing ischemia 12h after symptom onset
  • Continued ischemic chest pain > 30min
  • ST-segment elevation ≥ 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB)
  • Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL)
  • Primary coronary artery angiography was planned.

Exclusion Criteria:

  • Emergency thrombolytic therapy was performed before primary coronary artery angiography
  • Cardiogenic shock with no response to hypervolemic treatment or vasopressor
  • Severe cardiomyopathy or valvular disease requiring intervention
  • Coronary ectasia
  • Severe heart failure
  • Contraindication or allergy to antiplatelet drugs
  • Contraindication or allergy to experimental drugs
  • Unable to receive at least 1 year of dual antiplatelet therapy
  • Active bleeding or extreme-risk for major bleeding
  • Severe liver or renal failure
  • Life expectancy < 1 year
  • Unable or unwilling to provide informed consent
  • Women of child bearing potential
  • Under 18 years of age
  • Hemoglobin < 90g/L
  • Platelet count < 100×10^9/L
  • Can not cooperate (with mental disorders or cognitive disorders)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Nitroprusside group
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Nitroprusside Sodium via guide-catheter was performed. Then repeated administration of Nitroprusside Sodium was done prior to coronary stent implantation or post dilatation.
Drug: Nitroprusside Sodium
Intracoronary infusion 50~100μg each time (repeated)
Other Names:
  • Experimental-1 group
Experimental: Tirofiban group
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Tirofiban Hydrochloride via guide-catheter was performed.
Drug: Tirofiban Hydrochloride
Intracoronary infusion 10μg/kg for single time
Other Names:
  • Experimental-2 group
Placebo Comparator: Control group
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of heparinized saline via guide-catheter was performed.
Drug: Heparinized saline
Intracoronary infusion 2ml for single time
Other Names:
  • Control group

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
Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation
Time Frame: 1 minute after stent implantation
Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.
1 minute after stent implantation
Coronary artery flow using TIMI flow grade after balloon dilatation
Time Frame: 1 minute after balloon dilatation
Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.
1 minute after balloon dilatation
Coronary TIMI frame count after stent implantation
Time Frame: 1 minute after stent implantation
A continuous measurement assessing flow in the epicardial arteries.
1 minute after stent implantation
Coronary TIMI frame count after balloon dilatation
Time Frame: 1 minute after balloon dilatation
A continuous measurement assessing flow in the epicardial arteries.
1 minute after balloon dilatation
Slow flow / no-reflow phenomenon after stent implantation
Time Frame: 1 minute after stent implantation
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
1 minute after stent implantation
Slow flow / no-reflow phenomenon after balloon dilatation
Time Frame: 1 minute after balloon dilatation
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
1 minute after balloon dilatation
ECG ST-segment fall more than 50%
Time Frame: in 2 hours post-PCI
The extent of ST segment elevation was reduced by more than 50%
in 2 hours post-PCI

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
Main adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame: at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI
Death, Cardiac death, Rehospitalization (Heart failure) , Non-fatal myocardial infarction, Target vessel myocardial infarction, Target lesion revascularization, Target vessel revascularization, Ischemic-driven revascularization, Stent thrombosis, Bleeding, Cerebrovascular events, etc.
at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI

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.
The First Affiliated Hospital of Zhengzhou University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Henan University of Science and Technology
First Affiliated Hospital of Xinjiang Medical University
The First People's Hospital of Shangqiu
Puyang Oilfield General Hospital
Nanyang Central Hospital
Shenma Medical Group General Hospital
Xinyang Central Hospital
Huaihe Hospital of Henan University
Kaifeng Central Hospital
Zhengzhou Cardiovascular Hospital
Zhengzhou Central Hospital
People's Hospital of Zhengzhou University
Anyang Regional Hospital
Yellow River Sanmenxia hospital
The Peoples' Hospital of Jiaozuo City
Jincheng People's Hospital
The second people's Hospital of Jiyuan
Lushan People's Hospital
The Second People's Hospital of Pingdingshan
Puyang People's Hospital
Yanshi People's Hospital
The First People's Hospital of Xinmi
Zhengzhou First People's Hospital
The 99th Central Hospital of the People's Liberation Army
Zhoukou Central Hospital
The First People's Hospital of Zhumadian
Zhumadian Central 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.
  • Principal Investigator: Chunguang Qiu, Phd, the First Affiliated Hospital of Zhengzhou University

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.
January 7, 2018

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.
December 31, 2018

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.
December 31, 2019

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).
January 8, 2018

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.
January 19, 2018

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.
January 23, 2018

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.
January 23, 2018

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.
January 19, 2018

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.
January 1, 2018

More Information

Terms related to this study

Keywords

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.
  • KS-2017-176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on ST Segment Elevation Myocardial Infarction

Clinical Trials on Nitroprusside Sodium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings