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

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: NCT03406819
Recruitment Status : Unknown
Verified January 2018 by Chunguang Qiu, The First Affiliated Hospital of Zhengzhou University.
Recruitment status was:  Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
Anyang Regional Hospital
Huaihe Hospital of Henan University
The First Affiliated Hospital of Henan University of Science and Technology
Yellow River Sanmenxia hospital
The Peoples' Hospital of Jiaozuo City
Jincheng People's Hospital
The second people's Hospital of Jiyuan
Kaifeng Central Hospital
Lushan People's Hospital
Nanyang Central Hospital
The Second People's Hospital of Pingdingshan
Shenma Medical Group General Hospital
Puyang People's Hospital
Puyang Oilfield General Hospital
The First People's Hospital of Shangqiu
Yanshi People's Hospital
The First People's Hospital of Xinmi
First Affiliated Hospital of Xinjiang Medical University
Xinyang Central Hospital
People's Hospital of Zhengzhou University
Zhengzhou First People's Hospital
Zhengzhou Cardiovascular Hospital
Zhengzhou Central Hospital
The 99th Central Hospital of the People's Liberation Army
Zhoukou Central Hospital
The First People's Hospital of Zhumadian
Zhumadian Central Hospital
Information provided by (Responsible Party):
Chunguang Qiu, The First Affiliated Hospital of Zhengzhou University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ST Segment Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention Drug: Nitroprusside Sodium Drug: Tirofiban Hydrochloride Drug: Heparinized saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction
Actual Study Start Date : January 7, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: 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 Name: Control group


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Coronary TIMI frame count after stent implantation [ Time Frame: 1 minute after stent implantation ]
    A continuous measurement assessing flow in the epicardial arteries.

  4. Coronary TIMI frame count after balloon dilatation [ Time Frame: 1 minute after balloon dilatation ]
    A continuous measurement assessing flow in the epicardial arteries.

  5. 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.

  6. 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.

  7. 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%


Secondary Outcome Measures :
  1. 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.


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

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)
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): NCT03406819


Contacts
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Contact: Chunguang Qiu, Phd +86-13803898806 qcg123@163.com
Contact: Liang Pan, MD +86-15003851743 huzhoupanliang@gmail.com

Locations
Show Show 28 study locations
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University
Anyang Regional Hospital
Huaihe Hospital of Henan University
The First Affiliated Hospital of Henan University of Science and Technology
Yellow River Sanmenxia hospital
The Peoples' Hospital of Jiaozuo City
Jincheng People's Hospital
The second people's Hospital of Jiyuan
Kaifeng Central Hospital
Lushan People's Hospital
Nanyang Central Hospital
The Second People's Hospital of Pingdingshan
Shenma Medical Group General Hospital
Puyang People's Hospital
Puyang Oilfield General Hospital
The First People's Hospital of Shangqiu
Yanshi People's Hospital
The First People's Hospital of Xinmi
First Affiliated Hospital of Xinjiang Medical University
Xinyang Central Hospital
People's Hospital of Zhengzhou University
Zhengzhou First People's Hospital
Zhengzhou Cardiovascular Hospital
Zhengzhou Central 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
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Principal Investigator: Chunguang Qiu, Phd The First Affiliated Hospital of Zhengzhou University
More Information
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Responsible Party: Chunguang Qiu, Director of the Department of Cardiovascular Medicine, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT03406819    
Other Study ID Numbers: KS-2017-176
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chunguang Qiu, The First Affiliated Hospital of Zhengzhou University:
Prevention
Slow flow
No reflow
Nitroprusside
Tirofiban
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
 Nitroprusside
Tirofiban
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors