Prevention of Coronary Slow Flow or No-Reflow During PPCI in Patients With Acute STEMI
- Conditions
- ST Segment Elevation Myocardial InfarctionPrimary Percutaneous Coronary Intervention
- Interventions
- Registration Number
- NCT03406819
- Lead Sponsor
- The First Affiliated Hospital of Zhengzhou University
- 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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. 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.
- Primary Outcome Measures
Name Time Method Coronary TIMI frame count after balloon dilatation 1 minute after balloon dilatation A continuous measurement assessing flow in the epicardial arteries.
Coronary artery flow using TIMI flow grade after balloon dilatation 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 after stent implantation 1 minute after stent implantation A continuous measurement assessing flow in the epicardial arteries.
Slow flow / no-reflow phenomenon after stent implantation 1 minute 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 1 minute after balloon dilatation Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation 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.
ECG ST-segment fall more than 50% in 2 hours post-PCI The extent of ST segment elevation was reduced by more than 50%
- 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)
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
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Lushan People's Hospital
🇨🇳Lushan, 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
The 99th Central Hospital of the People's Liberation Army
🇨🇳Jiaozuo, Henan, China
Anyang District Hospital
🇨🇳Anyang, Henan, China
Kaifeng Central Hospital
🇨🇳Kaifeng, Henan, China