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

Phase 4

Completed

• Conditions: ST Segment Elevation Myocardial Infarction; Coronary Slow Flow Phenomenon
• Interventions: Drug: Nitroglycerin; Drug: Alprostadil

• Registration Number: NCT03296670
• Lead Sponsor: RenJi Hospital

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.

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 Timeline

• Study Start: 2015-08-01
• Primary Completion: 2017-04-28
• Study Completion: 2017-08-31
• Status Verified: 2017-09
• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-09-28
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nitroglycerin	Nitroglycerin	nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
alprostadil	Alprostadil	alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP

Primary Outcome Measures

Name	Time	Method
TIMI Frame Count (CTFC)	One mins after intracoronary medicine infusion post-PCI	CTFC is a continuous measurement assessing 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

Secondary Outcome Measures

Name	Time	Method
LVEF by echocardiography	Echocardiography was performed 3-7 days after PCI	Echocardiographic index includes LVEF

Trial Locations

Locations (1)

Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University; 🇨🇳 ShangHai, China