Protocol summary

Summary
Objectives: This study aims to comparison of Eptifibatide localized injection and intracoronary injection on the myocardial perfusion improvement and its outcomes. Design:The study is a randomized clinical trial,That will be done for 60 patients with thrombotic AMI. Setting and conduct: The patients will be undergoing percutaneous coronary intervention (PCI) and will be randomly(by using random number table method) dived into two equal number groups. Inclusion criteria: Diagnosis of ST elevation myocardial infarction as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission; these patients should also have three or more thrombus burden grade on the angiography; undergoing PCI; The consent of patients or their families to participate in the study; insensitivity to Eptifibatide. Exclusion criteria: Rescue PCI after thrombolytic therapy; Contraindications for antiplatelet; thrombocytopenia; recent stroke (less than 6 months) and cardiogenic shock. Intervention: The first group will be receiving two bolus doses (180 Microgram / kilogram) of Eptifibatide through guiding catheter. The second group will be receiving the same bolus doses through export aspiration catheter into the coronary lesion directly. Main outcome measures variables: Thrombolysis in myocardial infarction flow, myocardial blush grade and no-reflow phenomenon will primary end points. Secondary end points will pre and post-procedure cardiac arrhythmia, in-hospital mortality, adverse effects, reinfection, pre-discharge ventricular systolic function and re hospitalization and mortality after 6 month follow up.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016122722134N4
Registration date: 2017-01-07, 1395/10/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-07, 1395/10/18
Registrant information
Name
Mahtab Keshvari
Name of organization / entity
Cardiovascular Institution
Country
Iran (Islamic Republic of)
Phone
+98 913 781 0322
Email address
mkeshvari@crc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2016-05-22, 1395/03/02
Expected recruitment end date
2016-08-23, 1395/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison in myocardial perfusion between the intracoronary versus intralesional eptifibatide administration during primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction; A randomized clinical trial
Public title
Comparison in myocardial perfusion between the intracoronary versus intralesional eptifibatide administration in acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of ST elevation myocardial infarction (STEMI) as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission and symptoms onset time was less than 12 hours with 1 mm ST segment elevation in 2 or more contiguous leads (for V1-V3 ST elevation was 2 mm) simultaneously; These patients should also have three or more thrombus burden grade on the angiography. Thrombus burden was graded (G) as G0 = no thrombus, G1 = possible thrombus, G2 = small (greatest dimension ≤ 1/2 vessel diameter), G3 = moderate (> 1/2 but < 2 vessel diameter), G4 = large (≥ 2 vessel diameter), G5 = unable to assess TB due to vessel occlusion; undergoing PCI; The consent of patients or their families to participate in the study; insensitivity to Eptifibatide Exclusion criteria: Rescue PCI after thrombolytic therapy; Contraindications for antiplatelet such as bleeding disorder including gastrointestinal bleeding, hematuria, or known any bleeding tendency; thrombocytopenia (Platelet count<100.000/cm3); recent stroke (less than 6 months) and cardiogenic shock
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jirib St.
City
Isfahan
Postal code
8187698191
Approval date
2016-05-18, 1395/02/29
Ethics committee reference number
IR.MUI.REC.1395.2.395420

Health conditions studied

1

Description of health condition studied
cardiovascular disease
ICD-10 code
I20-I25
ICD-10 code description
Certain current complications following acute myocardial infarction

Primary outcomes

1

Description
Thrombolysis in myocardial infarction (TIMI) flow
Timepoint
Before discharge, re hospitalization and after 6 month follow up
Method of measurement
TIMI flow grading

2

Description
myocardial blush grade (MBG)
Timepoint
Before discharge, re hospitalization and after 6 month follow up
Method of measurement
Myocardial blush grading

3

Description
no-reflow phenomenon
Timepoint
Before discharge, re hospitalization and after 6 month follow up
Method of measurement
TIMI flow grading and Myocardial blush grading

Secondary outcomes

1

Description
Re myocardial infarction
Timepoint
Before discharge, re hospitalization and after 6 month follow up
Method of measurement
ECG

2

Description
Heart failure
Timepoint
during hospitalization
Method of measurement
Eco cardiography

3

Description
arrhythmia
Timepoint
Before discharge, re hospitalization and after 6 month follow up
Method of measurement
ECG

4

Description
Ventricular systolic function
Timepoint
Before discharge, re hospitalization and after 6 month follow up
Method of measurement
Eco cardiography

Intervention groups

1

Description
In group I, before performing PCI, if caught thrombosis in (180 micrograms per kilogram) coronary arteries, patients received two boluses of eptifibatide through the guiding catheter in the infarct-related
Category
Treatment - Drugs

2

Description
In group II or intralesional administration group boluses of eptifibatide(180 micrograms per kilogram) is administered through the export aspiration catheter into the lesion of infarct-related artery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Cardiology Hospital
Full name of responsible person
Dr. Hassan Shamiran
Street address
Iran, Isfahan, Chamran Cardiology Hospital, Salman-e-Farsi
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mehdi Nematbakhsh
Street address
Hezar Jerib Ave., Azadi sqr., Isfahan University of Medical Science, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abdulattef Ghazal
Position
Cardiology Interventional Fellowship
Other areas of specialty/work
Street address
Hezar Jerib Ave., Azadi sqr., Isfahan University of Medical Science, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3260 0961
Fax
Email
dr.abdghazal@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Hassan Shemirani
Position
Cardiology Interventional Fellowship
Other areas of specialty/work
Street address
Hezar Jerib Ave., Azadi sqr., Isfahan University of Medical Science, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3260 0961
Fax
Email
shemirani@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Abdulattef Ghazal
Position
Cardiology Interventional Fellowship
Other areas of specialty/work
Street address
Hezar Jerib Ave., Azadi sqr., Isfahan University of Medical Science, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3260 0961
Fax
Email
dr.abdghazal@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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