Prevention of Coronary Slow Flow or No-Reflow During EPCI in Patients With Acute STEMI
NCT ID: NCT03406832
Last Updated: 2019-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2018-01-08
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
Nitroprusside Sodium
Intracoronary infusion 50\~100μg each time (repeated)
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.
Tirofiban Hydrochloride
Intracoronary infusion 10μg/kg for single time
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.
Heparinized saline
Intracoronary infusion 2ml for single time
Interventions
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Nitroprusside Sodium
Intracoronary infusion 50\~100μg each time (repeated)
Tirofiban Hydrochloride
Intracoronary infusion 10μg/kg for single time
Heparinized saline
Intracoronary infusion 2ml for single time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* Elective coronary artery angiography was planned.
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Anyang Regional Hospital
OTHER
Huaihe Hospital of Henan University
OTHER
The First Affiliated Hospital of Henan University of Science and Technology
OTHER
Yellow River Sanmenxia hospital
UNKNOWN
The Peoples' Hospital of Jiaozuo City
OTHER
Jincheng People's Hospital
OTHER
The second people's Hospital of Jiyuan
UNKNOWN
Kaifeng Central Hospital
OTHER
Lushan People's Hospital
UNKNOWN
Nanyang Central Hospital
OTHER
The Second People's Hospital of Pingdingshan
UNKNOWN
Shenma Medical Group General Hospital
OTHER
Puyang People's Hospital
UNKNOWN
Puyang Oilfield General Hospital
OTHER
The First People's Hospital of Shangqiu
UNKNOWN
Yanshi People's Hospital
UNKNOWN
The First People's Hospital of Xinmi
UNKNOWN
First Affiliated Hospital of Xinjiang Medical University
OTHER
Xinyang Central Hospital
OTHER
People's Hospital of Zhengzhou University
OTHER
Zhengzhou First People's Hospital
UNKNOWN
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Zhengzhou Central Hospital
OTHER
The 99th Central Hospital of the People's Liberation Army
UNKNOWN
Zhoukou Central Hospital
OTHER
The First People's Hospital of Zhumadian
UNKNOWN
Zhumadian Central Hospital
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Responsible Party
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Chunguang Qiu
Director of the Department of Cardiovascular Medicine
Principal Investigators
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Chunguang Qiu, Phd
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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Anyang District Hospital
Anyang, Henan, China
The 99th Central Hospital of the People's Liberation Army
Jiaozuo, Henan, China
The People's Hospital of Jiaozuo
Jiaozuo, Henan, China
The second people's Hospital of Jiyuan
Jiyuan, Henan, China
Huaihe Hospital of Henan University
Kaifeng, Henan, China
Kaifeng Central Hospital
Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Lushan People's Hospital
Luyang, Henan, China
Nanyang City Center Hospital
Nanyang, Henan, China
Pingmei Shenma Medical Group General Hospital
Pingdingshan, Henan, China
The Second People's Hospital of Pingdingshan
Pingdingshan, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Puyang People's Hospital
Puyang, Henan, China
Yellow River Sanmenxia hospital
Sanmenxia, Henan, China
The First People's Hospital of Shangqiu
Shangqiu, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Xinyang Central Hospital
Xinyang, Henan, China
Yanshi People's Hospital
Yanshi, Henan, China
Zhengzhou First People's Hospital
Zhengzhou, Henan, China
Zhengzhou Cardiovascular Hospital
Zhengzhou, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The First People's Hospital of Xinmi
Zhengzhou, Henan, China
Zhoukou Central Hospital
Zhoukou, Henan, China
The First People's Hospital of Zhumadian
Zhumadian, Henan, China
Zhumadian Central Hospital
Zhumadian, Henan, China
Jincheng People's Hospital
Jincheng, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Chunguang Qiu, Phd
Role: primary
Other Identifiers
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KS-2017-177
Identifier Type: -
Identifier Source: org_study_id
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