Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP

Study Overview
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Brief Summary
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The study intends to evaluate the efficacy of different medicine delivering by targeted perfusion catheter in coronary administration on coronary blood flow in STEMI patients with CSFP.

Detailed Description
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The goal of STEMI therapy is to successfully restore epicardial blood flow. PCI has been documented as being the most effective method for restoration of epicardial blood flow. However, stenting does not necessarily equate to epicardial blood flow; not every patient achieves TIMI 3 flow after successful PCI. Currently, there are two main types of interventions to improve epicardial blood flow. One is the mechanical method, which included thrombus aspiration catheter and the distal protective devices. It has been confirmed that the mechanical method can effectively improve epicardial and myocardial perfusion in patient with part of large vessels and high burden thrombus. But for patients with small vessels and no obvious visual thrombus, the efficacy is not significant. The other intervention is medicine which included GP IIb/IIIa receptor antagonist, adenosine, sodium nitroprusside, verapamil etc. Part of the drugs have some effect but the overall clinical efficacy is still not satisfied. The study intends to use targeted perfusion catheter to deliver drug to the distal targeted blood vessels. TFG and cTFC are applied to evaluate the efficacy of treatment with Alprostadil or Nitroglycerin on coronary blood flow in STEMI patients with CSFP.

Official Title
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Intracoronary Infusion of Alprostadil and Nitroglycerin With Targeted Perfusion Microcatheter in STEMI Patients With Coronary Slow Flow Phenomenon

Conditions
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ST Segment Elevation Myocardial Infarction, Coronary Slow Flow Phenomenon

Intervention / Treatment
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* Drug: Alprostadil
* Drug: Nitroglycerin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patents with myocardial infarction who have symptom onset within 12h before randomization; ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ; Corrected TIMI frame counted (cTFC) measured from the final angiographic imaging after PCI exceeding 40 frames; Signed informed consent form prior to trial participation. Exclusion Criteria: Coronary artery bypass surgery (CABG) history; Failed in stents implanting; Severe heart failure; Cardiogenic shock.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alprostadil<br>alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP | Drug: Alprostadil<br>* alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP<br>|
| Placebo Comparator: nitroglycerin<br>nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP | Drug: Nitroglycerin<br>* Nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI Flow Grade (TFG) | TIMI Flow Grade (TFG)assesses flow in the epicardial arteries | One mins after PCI | 
| TIMI Flow Grade (TFG) | TIMI Flow Grade (TFG)assesses flow in the epicardial arteries | One mins after intracoronary medicine infusion post-PCI | 
| TIMI Frame Count (CTFC) | CTFC is a continuous measurement assessing flow in the epicardial arteries. | One mins after PCI | 
| TIMI Frame Count (CTFC) | CTFC is a continuous measurement assessing flow in the epicardial arteries. | One mins after intracoronary medicine infusion post-PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF by echocardiography | Echocardiographic index includes LVEF | Echocardiography was performed 3-7 days after PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, CSFP, Alprostadil, targeted perfusion microcatheter