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| Name | Class |
|---|---|
| Anyang Regional Hospital | OTHER |
| Huaihe Hospital of Henan University | OTHER |
| The First Affiliated Hospital of Henan University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitroprusside group | Experimental | 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. |
|
| Tirofiban group | Experimental | 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. |
|
| Control group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroprusside Sodium | Drug | Intracoronary infusion 50~100μg each time (repeated) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 minute after stent implantation |
| 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. | 1 minute after balloon dilatation |
| Coronary TIMI frame count after stent implantation | A continuous measurement assessing flow in the epicardial arteries. | 1 minute after stent implantation |
| Coronary TIMI frame count after balloon dilatation | A continuous measurement assessing flow in the epicardial arteries. | 1 minute after balloon dilatation |
| Slow flow / no-reflow phenomenon after stent implantation | Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree. | 1 minute after stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunguang Qiu, Phd | Contact | +86-13803898806 | qcg123@163.com | |
| Liang Pan, MD | Contact | +86-15003851743 | huzhoupanliang@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunguang Qiu, Phd | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anyang District Hospital | Recruiting | Anyang | Henan | 455000 | China | |
| The 99th Central Hospital of the People's Liberation Army |
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| 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 |
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| Tirofiban Hydrochloride | Drug | Intracoronary infusion 10μg/kg for single time |
|
|
| Heparinized saline | Drug | Intracoronary infusion 2ml for single time |
|
|
| Slow flow / no-reflow phenomenon after balloon dilatation | Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree. | 1 minute after balloon dilatation |
| ECG ST-segment fall more than 50% | The extent of ST segment elevation was reduced by more than 50% | in 2 hours post-PCI |
| Recruiting |
| Jiaozuo |
| Henan |
| 454000 |
| China |
| The People's Hospital of Jiaozuo | Recruiting | Jiaozuo | Henan | 454002 | China |
| The second people's Hospital of Jiyuan | Recruiting | Jiyuan | Henan | 454000 | China |
| Huaihe Hospital of Henan University | Recruiting | Kaifeng | Henan | 475000 | China |
| Kaifeng Central Hospital | Recruiting | Kaifeng | Henan | 475000 | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 471003 | China |
| Lushan People's Hospital | Recruiting | Lushan | Henan | 467300 | China |
| Nanyang City Center Hospital | Recruiting | Nanyang | Henan | 473000 | China |
| Pingmei Shenma Medical Group General Hospital | Recruiting | Pingdingshan | Henan | 467000 | China |
| The Second People's Hospital of Pingdingshan | Recruiting | Pingdingshan | Henan | 467000 | China |
| Puyang Oilfield General Hospital | Recruiting | Puyang | Henan | 457000 | China |
| Puyang People's Hospital | Recruiting | Puyang | Henan | 457099 | China |
| Yellow River Sanmenxia hospital | Recruiting | Sanmenxia | Henan | 472000 | China |
| The First People's Hospital of Shangqiu | Recruiting | Shangqiu | Henan | 476000 | China |
| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | 453100 | China |
| Xinyang Central Hospital | Recruiting | Xinyang | Henan | 464000 | China |
| Yanshi People's Hospital | Recruiting | Yanshi | Henan | 471900 | China |
| Zhengzhou First People's Hospital | Recruiting | Zhengzhou | Henan | 450004 | China |
| Zhengzhou Cardiovascular Hospital | Recruiting | Zhengzhou | Henan | 450006 | China |
| Zhengzhou Central Hospital | Recruiting | Zhengzhou | Henan | 450007 | China |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
|
| People's Hospital of Zhengzhou | Recruiting | Zhengzhou | Henan | 450053 | China |
| The First People's Hospital of Xinmi | Recruiting | Zhengzhou | Henan | 452370 | China |
| Zhoukou Central Hospital | Recruiting | Zhoukou | Henan | 466000 | China |
| The First People's Hospital of Zhumadian | Recruiting | Zhumadian | Henan | 463000 | China |
| Zhumadian Central Hospital | Recruiting | Zhumadian | Henan | 463000 | China |
| Jincheng People's Hospital | Recruiting | Jincheng | Shanxi | 048026 | China |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D009599 | Nitroprusside |
| D000077466 | Tirofiban |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D005292 | Ferricyanides |
| D003486 | Cyanides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D006856 | Hydrogen Cyanide |
| D017672 | Nitrogen Compounds |
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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