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

Primary Purpose

ST Segment Elevation Myocardial Infarction, Primary Percutaneous Coronary Intervention

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nitroprusside Sodium
Tirofiban Hydrochloride
Heparinized saline
Sponsored by
The First Affiliated Hospital of Zhengzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ST Segment Elevation Myocardial Infarction focused on measuring Prevention, Slow flow, No reflow, Nitroprusside, Tirofiban

Eligibility Criteria

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

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)

Sites / Locations

  • Anyang District HospitalRecruiting
  • The 99th Central Hospital of the People's Liberation ArmyRecruiting
  • The People's Hospital of JiaozuoRecruiting
  • The second people's Hospital of JiyuanRecruiting
  • Huaihe Hospital of Henan UniversityRecruiting
  • Kaifeng Central HospitalRecruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • Lushan People's HospitalRecruiting
  • Nanyang City Center HospitalRecruiting
  • Pingmei Shenma Medical Group General HospitalRecruiting
  • The Second People's Hospital of PingdingshanRecruiting
  • Puyang Oilfield General HospitalRecruiting
  • Puyang People's HospitalRecruiting
  • Yellow River Sanmenxia hospitalRecruiting
  • The First People's Hospital of ShangqiuRecruiting
  • The First Affiliated Hospital of Xinxiang Medical UniversityRecruiting
  • Xinyang Central HospitalRecruiting
  • Yanshi People's HospitalRecruiting
  • Zhengzhou First People's HospitalRecruiting
  • Zhengzhou Cardiovascular HospitalRecruiting
  • Zhengzhou Central HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • People's Hospital of ZhengzhouRecruiting
  • The First People's Hospital of XinmiRecruiting
  • Zhoukou Central HospitalRecruiting
  • The First People's Hospital of ZhumadianRecruiting
  • Zhumadian Central HospitalRecruiting
  • Jincheng People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Nitroprusside group

Tirofiban group

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade 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.
Coronary artery flow using TIMI flow grade 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.
Coronary TIMI frame count after stent implantation
A continuous measurement assessing flow in the epicardial arteries.
Coronary TIMI frame count after balloon dilatation
A continuous measurement assessing flow in the epicardial arteries.
Slow flow / no-reflow phenomenon after stent implantation
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
Slow flow / no-reflow phenomenon after balloon dilatation
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
ECG ST-segment fall more than 50%
The extent of ST segment elevation was reduced by more than 50%

Secondary Outcome Measures

Main adverse cardiovascular and cerebrovascular events (MACCE)
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.

Full Information

First Posted
January 8, 2018
Last Updated
January 19, 2018
Sponsor
The First Affiliated Hospital of Zhengzhou University
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
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1. Study Identification

Unique Protocol Identification Number
NCT03406819
Brief Title
Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI
Acronym
NOSLOWFLOW-Ⅰ
Official Title
Prevention of Coronary Slow Flow or No-Reflow During Primary Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Zhengzhou University
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Segment Elevation Myocardial Infarction, Primary Percutaneous Coronary Intervention
Keywords
Prevention, Slow flow, No reflow, Nitroprusside, Tirofiban

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nitroprusside group
Arm Type
Experimental
Arm Description
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.
Arm Title
Tirofiban group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nitroprusside Sodium
Other Intervention Name(s)
Experimental-1 group
Intervention Description
Intracoronary infusion 50~100μg each time (repeated)
Intervention Type
Drug
Intervention Name(s)
Tirofiban Hydrochloride
Other Intervention Name(s)
Experimental-2 group
Intervention Description
Intracoronary infusion 10μg/kg for single time
Intervention Type
Drug
Intervention Name(s)
Heparinized saline
Other Intervention Name(s)
Control group
Intervention Description
Intracoronary infusion 2ml for single time
Primary Outcome Measure Information:
Title
Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation
Description
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.
Time Frame
1 minute after stent implantation
Title
Coronary artery flow using TIMI flow grade after balloon dilatation
Description
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.
Time Frame
1 minute after balloon dilatation
Title
Coronary TIMI frame count after stent implantation
Description
A continuous measurement assessing flow in the epicardial arteries.
Time Frame
1 minute after stent implantation
Title
Coronary TIMI frame count after balloon dilatation
Description
A continuous measurement assessing flow in the epicardial arteries.
Time Frame
1 minute after balloon dilatation
Title
Slow flow / no-reflow phenomenon after stent implantation
Description
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
Time Frame
1 minute after stent implantation
Title
Slow flow / no-reflow phenomenon after balloon dilatation
Description
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
Time Frame
1 minute after balloon dilatation
Title
ECG ST-segment fall more than 50%
Description
The extent of ST segment elevation was reduced by more than 50%
Time Frame
in 2 hours post-PCI
Secondary Outcome Measure Information:
Title
Main adverse cardiovascular and cerebrovascular events (MACCE)
Description
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.
Time Frame
at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunguang Qiu, Phd
Phone
+86-13803898806
Email
qcg123@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Pan, MD
Phone
+86-15003851743
Email
huzhoupanliang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunguang Qiu, Phd
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anyang District Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455000
Country
China
Individual Site Status
Recruiting
Facility Name
The 99th Central Hospital of the People's Liberation Army
City
Jiaozuo
State/Province
Henan
ZIP/Postal Code
454000
Country
China
Individual Site Status
Recruiting
Facility Name
The People's Hospital of Jiaozuo
City
Jiaozuo
State/Province
Henan
ZIP/Postal Code
454002
Country
China
Individual Site Status
Recruiting
Facility Name
The second people's Hospital of Jiyuan
City
Jiyuan
State/Province
Henan
ZIP/Postal Code
454000
Country
China
Individual Site Status
Recruiting
Facility Name
Huaihe Hospital of Henan University
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475000
Country
China
Individual Site Status
Recruiting
Facility Name
Kaifeng Central Hospital
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Name
Lushan People's Hospital
City
Lushan
State/Province
Henan
ZIP/Postal Code
467300
Country
China
Individual Site Status
Recruiting
Facility Name
Nanyang City Center Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473000
Country
China
Individual Site Status
Recruiting
Facility Name
Pingmei Shenma Medical Group General Hospital
City
Pingdingshan
State/Province
Henan
ZIP/Postal Code
467000
Country
China
Individual Site Status
Recruiting
Facility Name
The Second People's Hospital of Pingdingshan
City
Pingdingshan
State/Province
Henan
ZIP/Postal Code
467000
Country
China
Individual Site Status
Recruiting
Facility Name
Puyang Oilfield General Hospital
City
Puyang
State/Province
Henan
ZIP/Postal Code
457000
Country
China
Individual Site Status
Recruiting
Facility Name
Puyang People's Hospital
City
Puyang
State/Province
Henan
ZIP/Postal Code
457099
Country
China
Individual Site Status
Recruiting
Facility Name
Yellow River Sanmenxia hospital
City
Sanmenxia
State/Province
Henan
ZIP/Postal Code
472000
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Shangqiu
City
Shangqiu
State/Province
Henan
ZIP/Postal Code
476000
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Individual Site Status
Recruiting
Facility Name
Xinyang Central Hospital
City
Xinyang
State/Province
Henan
ZIP/Postal Code
464000
Country
China
Individual Site Status
Recruiting
Facility Name
Yanshi People's Hospital
City
Yanshi
State/Province
Henan
ZIP/Postal Code
471900
Country
China
Individual Site Status
Recruiting
Facility Name
Zhengzhou First People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450004
Country
China
Individual Site Status
Recruiting
Facility Name
Zhengzhou Cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450006
Country
China
Individual Site Status
Recruiting
Facility Name
Zhengzhou Central Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450007
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunguang Qiu, Phd
Facility Name
People's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450053
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Xinmi
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
452370
Country
China
Individual Site Status
Recruiting
Facility Name
Zhoukou Central Hospital
City
Zhoukou
State/Province
Henan
ZIP/Postal Code
466000
Country
China
Individual Site Status
Recruiting
Facility Name
The First People's Hospital of Zhumadian
City
Zhumadian
State/Province
Henan
ZIP/Postal Code
463000
Country
China
Individual Site Status
Recruiting
Facility Name
Zhumadian Central Hospital
City
Zhumadian
State/Province
Henan
ZIP/Postal Code
463000
Country
China
Individual Site Status
Recruiting
Facility Name
Jincheng People's Hospital
City
Jincheng
State/Province
Shanxi
ZIP/Postal Code
048026
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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