Objective: To assess the effect of prophylactic intracoronary adenosine infusion during primary percutaneous intervention in acute ST elevation myocardial infarction.
Design: Randomized control trial.
Setting: The eligible patients with acute ST elevation myocardial infarction who admitted to emergency room of Farshchian heart center during 2017-2018.
Inclusion criteria: (a) ST elevation MI in ECG; (b) LAD and LCX lesion; (c) coronary lesion suitable for angioplasty; (d) TIMI flow 0-1.
Exclusion criteria: (a) history of COPD or asthma; (b) patients who under treatment with dipyridamol; (c) Presentation with cardiogenic shock; (d) Patients who received fibrynolytic; (e) life expectancy less than 6 month; (f) stent thrombosis; (g) history of CABGs; (h) AV nodal block in first ECG; (I) TIMI flow 2-3 in angiography; (j) RCA lesion; (k) lack of patient satisfaction.
Intervention: Two separated doses of 40 microgram adenosine in 10 ml normal saline 0.9% intracoronary infusion during primary PCI on LAD or LCX.
Control: Two separated doses of Intracoronary 10 ml normal saline 0.9% infusion in left coronary system.
Primary outcome: (a) ST elevation resolution; (b) TIMI flow; (c) level of CKMB and troponin.
Secondary outcome: (a) inhospital mortality; (b) duration of hospitalization; (c) hemodynamic stability; (d) electrical stability; (e)left ventricular ejection fraction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062434621N1
Registration date:2017-08-05, 1396/05/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
Azadeh Mozayani Monfared
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1731
Email address
a.mozayani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic intracoronary Adenosine infusion during primary percutaneous coronary intervention in Acute ST Elevation Myocardial infarction
Public title
Effect of intracoronary Adenosine infusion during primary percutaneous coronary intervention in Acute Myocardial infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) ST elevation MI in ECG; (b) LAD and LCX lesion; (c) coronary lesion suitable for angioplasty; (d) TIMI flow 0-1.
Exclusion criteria: (a) history of COPD or asthma; (b) patients who under treatment with dipyridamol; (c) Presentation with cardiogenic shock; (d) Patients who received fibrynolytic; (e) life expectancy less than 6 month; (f) stent thrombosis; (g) history of CABGs; (h) AV nodal block in first ECG; (I) TIMI flow 2-3 in angiography; (j) RCA lesion; (k) lack of patient satisfaction.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
104
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
Local Human Subject Review Board
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave, Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.UMSHA.REC.1396.133
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
ST elevation resolution
Timepoint
Before and after intervention
Method of measurement
ECG
2
Description
TIMI flow
Timepoint
Before and after intervention
Method of measurement
Angioplasty
3
Description
level of CKMB and troponin
Timepoint
Before and after intervention
Method of measurement
Blood sample
Secondary outcomes
1
Description
Inhospital mortality
Timepoint
After intervention
Method of measurement
check list
2
Description
duration of hospitalization
Timepoint
After intervention
Method of measurement
check list
3
Description
hemodynamic stability
Timepoint
After intervention
Method of measurement
check list
4
Description
electrical stability
Timepoint
After intervention
Method of measurement
ECG
5
Description
Left ventricular ejection fraction
Timepoint
After intervention
Method of measurement
Echocardiography
Intervention groups
1
Description
Intervention group: Two separated doses of 40 microgram adenosine in 10 ml normal saline 0.9% intracoronary infusion during primary PCI on LAD or LCX.
Category
Prevention
2
Description
Control group: Two separated doses of Intracoronary 10 ml normal saline 0.9% infusion in left coronary system.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Heart Center
Full name of responsible person
Behshad Naghshtabrizi
Street address
Farshchian Heart Center, Shaheed Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Vic-chancellor of Research and Technology, Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vic-chancellor of Research and Technology, Hamadan 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
Clinical Research Development Unit of Farshchian Heart Center, Department of Cardiology
Full name of responsible person
Manijeh Sajedi
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Shaheed Fahmideh Ave., Farshchian Heart Center
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1731
Fax
Email
manijehsajedi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Cardiology, School of Medicine
Full name of responsible person
Behshad Naghshtabrizi
Position
MD, Associate Professor of Cardiology
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1731
Fax
Email
dbnaghsh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Cardiology, School of Medicine
Full name of responsible person
Azadeh Mozayani Monfared
Position
Cardiologist
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shaheed Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1731
Fax
Email
a.mozayani@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)