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

Primary Purpose

ST Segment Elevation Myocardial Infarction, Coronary Slow Flow Phenomenon

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Alprostadil
Nitroglycerin
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Segment Elevation Myocardial Infarction focused on measuring STEMI, CSFP, Alprostadil, targeted perfusion microcatheter

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

Coronary artery bypass surgery (CABG) history; Failed in stents implanting; Severe heart failure; Cardiogenic shock.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

alprostadil

nitroglycerin

Arm Description

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

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

Outcomes

Primary Outcome Measures

TIMI Flow Grade (TFG)
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
TIMI Flow Grade (TFG)
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
TIMI Frame Count (CTFC)
CTFC is a continuous measurement assessing flow in the epicardial arteries.
TIMI Frame Count (CTFC)
CTFC is a continuous measurement assessing flow in the epicardial arteries.

Secondary Outcome Measures

LVEF by echocardiography
Echocardiographic index includes LVEF

Full Information

First Posted
September 25, 2017
Last Updated
March 11, 2020
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03296670
Brief Title
Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients With CSFP
Official Title
Intracoronary Infusion of Alprostadil and Nitroglycerin With Targeted Perfusion Microcatheter in STEMI Patients With Coronary Slow Flow Phenomenon
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
April 28, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Segment Elevation Myocardial Infarction, Coronary Slow Flow Phenomenon
Keywords
STEMI, CSFP, Alprostadil, targeted perfusion microcatheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
alprostadil
Arm Type
Experimental
Arm Description
alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
Arm Title
nitroglycerin
Arm Type
Placebo Comparator
Arm Description
nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
Intervention Type
Drug
Intervention Name(s)
Alprostadil
Intervention Description
alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
Nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
Primary Outcome Measure Information:
Title
TIMI Flow Grade (TFG)
Description
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
Time Frame
One mins after PCI
Title
TIMI Flow Grade (TFG)
Description
TIMI Flow Grade (TFG)assesses flow in the epicardial arteries
Time Frame
One mins after intracoronary medicine infusion post-PCI
Title
TIMI Frame Count (CTFC)
Description
CTFC is a continuous measurement assessing flow in the epicardial arteries.
Time Frame
One mins after PCI
Title
TIMI Frame Count (CTFC)
Description
CTFC is a continuous measurement assessing flow in the epicardial arteries.
Time Frame
One mins after intracoronary medicine infusion post-PCI
Secondary Outcome Measure Information:
Title
LVEF by echocardiography
Description
Echocardiographic index includes LVEF
Time Frame
Echocardiography was performed 3-7 days after PCI

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben He, MD,PhD
Organizational Affiliation
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
City
ShangHai
Country
China

12. IPD Sharing Statement

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

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