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History of Changes for Study: NCT03406819
Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI (NOSLOWFLOW-Ⅰ)
Latest version (submitted January 19, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 19, 2018 None (earliest Version on record)
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Study NCT03406819
Submitted Date:  January 19, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: KS-2017-176
Brief Title: Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI (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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2018
Overall Status: Unknown status [Previously: Recruiting]
Study Start: January 7, 2018
Primary Completion: December 31, 2018 [Anticipated]
Study Completion: December 31, 2019 [Anticipated]
First Submitted: January 8, 2018
First Submitted that
Met QC Criteria:
January 19, 2018
First Posted: January 23, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
January 19, 2018
Last Update Posted: January 23, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: The First Affiliated Hospital of Zhengzhou University
Responsible Party: Principal Investigator
Investigator: Chunguang Qiu
Official Title: Director of the Department of Cardiovascular Medicine
Affiliation: 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
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: ST Segment Elevation Myocardial Infarction
Primary Percutaneous Coronary Intervention
Keywords: Prevention
Slow flow
No reflow
Nitroprusside
Tirofiban
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 1000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Study Officials: Chunguang Qiu, Phd
Principal Investigator
The First Affiliated Hospital of Zhengzhou University
Locations: China, Henan
Anyang District Hospital
Anyang, Henan, China, 455000
The 99th Central Hospital of the People's Liberation Army
Jiaozuo, Henan, China, 454000
The People's Hospital of Jiaozuo
Jiaozuo, Henan, China, 454002
The second people's Hospital of Jiyuan
Jiyuan, Henan, China, 454000
Huaihe Hospital of Henan University
Kaifeng, Henan, China, 475000
Kaifeng Central Hospital
Kaifeng, Henan, China, 475000
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Lushan People's Hospital
Lushan, Henan, China, 467300
Nanyang City Center Hospital
Nanyang, Henan, China, 473000
Pingmei Shenma Medical Group General Hospital
Pingdingshan, Henan, China, 467000
The Second People's Hospital of Pingdingshan
Pingdingshan, Henan, China, 467000
Puyang Oilfield General Hospital
Puyang, Henan, China, 457000
Puyang People's Hospital
Puyang, Henan, China, 457099
Yellow River Sanmenxia hospital
Sanmenxia, Henan, China, 472000
The First People's Hospital of Shangqiu
Shangqiu, Henan, China, 476000
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Xinyang Central Hospital
Xinyang, Henan, China, 464000
Yanshi People's Hospital
Yanshi, Henan, China, 471900
Zhengzhou First People's Hospital
Zhengzhou, Henan, China, 450004
Zhengzhou Cardiovascular Hospital
Zhengzhou, Henan, China, 450006
Zhengzhou Central Hospital
Zhengzhou, Henan, China, 450007
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Contact:Contact: Chunguang Qiu, Phd
People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450053
The First People's Hospital of Xinmi
Zhengzhou, Henan, China, 452370
Zhoukou Central Hospital
Zhoukou, Henan, China, 466000
The First People's Hospital of Zhumadian
Zhumadian, Henan, China, 463000
Zhumadian Central Hospital
Zhumadian, Henan, China, 463000
China, Shanxi
Jincheng People's Hospital
Jincheng, Shanxi, China, 048026
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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