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Completed

NCT Number: NCT03296670

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alprostadil

Drug

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

Nitroglycerin

Drug

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

Primary outcomes

  1. TIMI Flow Grade (TFG)

    Time frame: One mins after PCI

    TIMI Flow Grade (TFG)assesses flow in the epicardial arteries

  2. TIMI Flow Grade (TFG)

    Time frame: One mins after intracoronary medicine infusion post-PCI

    TIMI Flow Grade (TFG)assesses flow in the epicardial arteries

  3. TIMI Frame Count (CTFC)

    Time frame: One mins after PCI

    CTFC is a continuous measurement assessing flow in the epicardial arteries.

  4. TIMI Frame Count (CTFC)

    Time frame: One mins after intracoronary medicine infusion post-PCI

    CTFC is a continuous measurement assessing flow in the epicardial arteries.

Secondary outcomes

  1. LVEF by echocardiography

    Time frame: Echocardiography was performed 3-7 days after PCI

    Echocardiographic index includes LVEF

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2017
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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