Prevention of Coronary Slow Flow or No-Reflow During Elective Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction
Overview
- Phase
- Not Applicable
- Intervention
- Nitroprusside Sodium
- Conditions
- ST Segment Elevation Myocardial Infarction
- Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Enrollment
- 1000
- Locations
- 28
- Primary Endpoint
- Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade
- Last Updated
- 6 years ago
Overview
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.
Investigators
Chunguang Qiu
Director of the Department of Cardiovascular Medicine
The First Affiliated Hospital of Zhengzhou University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Nitroprusside Sodium
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.
Intervention: Tirofiban Hydrochloride
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.
Intervention: Heparinized saline
Outcomes
Primary Outcomes
Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade
Time Frame: 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
Time Frame: 1 minute after stent implantation; 1 minute after balloon dilatation
A continuous measurement assessing flow in the epicardial arteries.
Slow flow / no-reflow phenomenon
Time Frame: 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 Outcomes
- Main adverse cardiovascular and cerebrovascular events (MACCE)(at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI)