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

Sponsor

RenJi Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03296670

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
ST Segment Elevation Myocardial Infarction Coronary Slow Flow Phenomenon	Drug: Alprostadil Drug: Nitroglycerin	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Apr 28, 2017

Actual Study Completion Date :

Aug 31, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: alprostadil

alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

Drug: Alprostadil

alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

Placebo Comparator: nitroglycerin

nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

Drug: Nitroglycerin

Nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

LVEF by echocardiography [Echocardiography was performed 3-7 days after PCI]
Echocardiographic index includes LVEF

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.