A Comparison of Intracoronary with Intravenous Administration of Integrilin During Primary Percutaneous Coronary Intervention in Patients with acute ST-Elevation Myocardial Infarction: Clinical Outcomes
Purpose: Treatment
Study Design: Randomizedm, Double-blinded, Single center, Clinical Trial
Inclusion Criteria: an acute coronary syndrome with the indication for cardiac catheterization being ST-elevation myocardial infarction; coronary artery disease with a visually estimated stenosis of at least 75% in at least 1 epicardial vessel suitable for stenting; age 18 years;
Exclusion Criteria: multivessel PCI at the time of the index procedure or planned PCI within 30 days of the index procedure; severe coronary calcification; unprotected left main stenosis 50%; target lesion in a saphenous vein graft; acute ST-elevation myocardial infarction with a primary PCI strategy; previous stenting at the target lesion; target lesion in an occluded vessel; and a contraindication to GP IIb/IIIa inhibitor therapy
Population: Patients with Acute STEMI admitted in Bu Ali Hospital, Qazvin undergoing Primary PCI in time of study who has inclusion criteria
Sample volume: 70 samples
Intervention: Intracoronary vs. intravenous administration of integrilin during Primary PCI
Time of Intervention: Within Primary PCI
Clinical Primary end pint: Microvascular perfusion assessment by TPG, TFG and cTFC
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012090510751N1
Registration date:2014-06-23, 1393/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-23, 1393/04/02
Registrant information
Name
Amir Esfandi
Name of organization / entity
Qazvin University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 5223
Email address
amir9esf@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research - Medical School - QUMS
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison of Intracoronary with Intravenous Administration of Integrilin During Primary Percutaneous Coronary Intervention in Patients with acute ST-Elevation Myocardial Infarction: Clinical Outcomes
Public title
Intracoronary Integrilin Administration in Patient with Acute ST-Elevation Myocardial Infarction undergoing Primary PCI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: an acute coronary syndrome with the indication for cardiac catheterization being ST-elevation myocardial infarction; coronary artery disease with a visually estimated stenosis of at least 75% in at least 1 epicardial vessel suitable for stenting; age 18 years; negative pregnancy test in women of childbearing potential; informed consent for participation in the trial
Exclusion Criteria: multivessel PCI at the time of the index procedure or planned PCI within 30 days of the index procedure; severe coronary calcification; unprotected left main stenosis >50%; target lesion in a saphenous vein graft; acute ST-elevation myocardial infarction after a primary PCI strategy; previous stenting at the target lesion; target lesion in an occluded vessel; deep vein thrombosis; presence of an inferior vena cava filter; a contraindication to GP IIb/IIIa inhibitor therapy (Hypersensitivity to eptifibatide or any component of the product; active abnormal bleeding within the previous 30 days or a history of bleeding diathesis; history of stroke within 30 days or a history of hemorrhagic stroke; severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately controlled on antihypertensive therapy; major surgery within the preceding 6 weeks; current or planned administration of another parenteral GP IIb/IIIa inhibitor; dependency on hemodialysis).
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Council of Ethics in Researches in Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences - Shahid Bahonar Buldv. - Qazvin
City
Qazvin
Postal code
59811-34197
Approval date
2012-11-27, 1391/09/07
Ethics committee reference number
20/5258/د
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
2
Description of health condition studied
Recurrent Myocardial Infarction
ICD-10 code
I22
ICD-10 code description
Subsequent myocardial infarction
Primary outcomes
1
Description
TIMI Flow Grade
Timepoint
Before and After Primary PCI
Method of measurement
Antrograde Coronary Perfusion assessed by Coronary Angiograpgy
2
Description
TIMI Perfusion Grade
Timepoint
Before and After Primary PCI
Method of measurement
Antrograde Coronary Perfusion assessed by Coronary Angiograpgy based on TPG classification
3
Description
TIMI Frame Count
Timepoint
Before and After Primary PCI
Method of measurement
Angioraphic frame count of contrast from injection to filling the coronary artery which underwent Primary PCI
Secondary outcomes
1
Description
Adverse Bleeding Event
Timepoint
From Primary PCI to Patient Discharge
Method of measurement
Incidence of Bleeding event during hospitalization based on International Bleeding classification
2
Description
Change in Ejection Fraction
Timepoint
Before Primary PCI and 5 days after
Method of measurement
By Echocardiography
3
Description
ST Segment Elevation Resolution
Timepoint
Before Primary PCI and 60 minutes after
Method of measurement
Single-lead ST elevation (ST-E) recovery (percent reduction in ST-E from baseline to post-PCI ECG in the lead with maximum baseline ST-E)
4
Description
Thrombocytopenia
Timepoint
Before Primary PCI and 3 hours after
Method of measurement
Reduction of Platelet in PBS over 50% or below 100000 per ml
Intervention groups
1
Description
In Intracoronary arm (intervention), 180 micogram per Kg of patient's body weight administer, 2 bolus 10 minutes apart, first before pass the guidewire and second bolus after passing the guidewire, as intracoronary injection.nfusion of 2 microgram per kg per minute of integrilin willl be continued intravenously up to 12 hours after procedure.
Category
Treatment - Drugs
2
Description
in IV arm (control), 180 microgram per Kg of patient's body weight of integrilin will be injected intravenously, 10 minutes apart, before and after passing the guidewire. Infusion of 2 microgram per kg per minute of integrilin willl be continued intravenously up to 12 hours after procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Sina Hospital
Full name of responsible person
Amir Esfandi
Street address
Qazvin - Buali Sina St. - Buali Sina Hospital
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
QUMS Deputy for Research
Full name of responsible person
Mahnaz Abbasi
Street address
Room No. 201 - 2nd floor - Faculty of Medicine - QUMS
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
QUMS Deputy for Research
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
Qazvin University of Medical Sciences
Full name of responsible person
Amir Esfandi
Position
Medical Student
Other areas of specialty/work
Street address
No 23. Davati alley - Northern Jamalzadeh St- Keshavarz Buld.
City
Tehran
Postal code
1419884491
Phone
+98 21 6642 5223
Fax
Email
amir9esf@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin Medical University of Medical Sciences
Full name of responsible person
Mohammad Fotouhi
Position
Intreventional Cardiologist
Other areas of specialty/work
Street address
Angiography Cath Lab - Buali Hospital
City
Qazvin
Postal code
Phone
+98 28 3333 2930
Fax
Email
fotuhi52@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Amir Esfandi
Position
Medical Intern
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
amir9esf@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)