Prevention of Coronary Slow Flow or No-Reflow During EPCI in Patients With Acute STEMI
- Conditions
- Elective Percutaneous Coronary InterventionST Segment Elevation Myocardial Infarction
- Interventions
- Registration Number
- NCT03406832
- Lead Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Brief Summary
Elective percutaneous coronary intervention (EPCI) is the common treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following EPCI 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 EPCI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- Ischemic symptoms < 2 weeks (> 24 hours)
- 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.
- Emergency thrombolytic therapy was performed before elective 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirofiban group Tirofiban Hydrochloride 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. Nitroprusside group Nitroprusside Sodium 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. Control group Heparinized saline 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.
- Primary Outcome Measures
Name Time Method Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade 1 minute after stent implantation; 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.
Coronary TIMI frame count 1 minute after stent implantation; 1 minute after balloon dilatation A continuous measurement assessing flow in the epicardial arteries.
Slow flow / no-reflow phenomenon 1 minute after stent implantation; 1 minute after balloon dilatation Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
- Secondary Outcome Measures
Name Time Method Main adverse cardiovascular and cerebrovascular events (MACCE) 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.
Trial Locations
- Locations (28)
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
The Second People's Hospital of Pingdingshan
🇨🇳Pingdingshan, Henan, China
Puyang Oilfield General Hospital
🇨🇳Puyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Zhengzhou First People's Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Zhoukou Central Hospital
🇨🇳Zhoukou, Henan, China
The First People's Hospital of Zhumadian
🇨🇳Zhumadian, Henan, China
Nanyang City Center Hospital
🇨🇳Nanyang, Henan, China
Lushan People's Hospital
🇨🇳Lushan, Henan, China
The second people's Hospital of Jiyuan
🇨🇳Jiyuan, Henan, China
Anyang District Hospital
🇨🇳Anyang, Henan, China
The People's Hospital of Jiaozuo
🇨🇳Jiaozuo, Henan, China
The 99th Central Hospital of the People's Liberation Army
🇨🇳Jiaozuo, Henan, China
Pingmei Shenma Medical Group General Hospital
🇨🇳Pingdingshan, Henan, China
The First People's Hospital of Shangqiu
🇨🇳Shangqiu, Henan, China
Puyang People's Hospital
🇨🇳Puyang, Henan, China
Yellow River Sanmenxia hospital
🇨🇳Sanmenxia, Henan, China
Xinyang Central Hospital
🇨🇳Xinyang, Henan, China
Yanshi People's Hospital
🇨🇳Yanshi, Henan, China
Zhengzhou Cardiovascular Hospital
🇨🇳Zhengzhou, Henan, China
The First People's Hospital of Xinmi
🇨🇳Zhengzhou, Henan, China
Zhengzhou Central Hospital
🇨🇳Zhengzhou, Henan, China
Zhumadian Central Hospital
🇨🇳Zhumadian, Henan, China
Jincheng People's Hospital
🇨🇳Jincheng, Shanxi, China