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

March 11, 2020 updated by: RenJi Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

April 28, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSG1501104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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