The objective of this trial is to investigate the effect of administration of Amiodarone on the mortality rate of arrhythmia following acute coronary syndrome. The main inclusion criteria is having acute coronary syndrome sign and symptoms. A total of 2400 patients whom transferred to the hospitals by EMS are recruited in the trial and randomly assigned to receive Amiodarone or distilled water before hospital admission. EKG findings and cardiac enzymes will be investigated on arrival to the hospital on the 7th and 30th day after beginning of symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905064357N2
Registration date:2010-09-30, 1389/07/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-09-30, 1389/07/08
Registrant information
Name
Ali Bidari
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2202 6576
Email address
bidarial@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Iranian Emergency and Disaster Managment Center
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-04-20, 1390/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pre-hospital administration of Amiodarone for reducing the short-time mortality of AICS.
Public title
Pre-hospital administration of Amiodarone for reducing the short-time mortality of AICS.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Presence of Acute Coronary Syndrome criteria referred to hospitals with EMS with the following conditions: diffuse precordial or substernal pain with at least 20 min duration and lasts until patient visits by EMS, no other significant diagnosis for present chest pain, age more than 45 years old in men and more than 50 years old in women, Systolic Blood Pressure 100mm/Hg or higher, Pulse Rate equal to 60 or more, no history of drug sensitivity to Amiodarone
Age
From 45 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
2400
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Postal code
Approval date
2010-09-12, 1389/06/21
Ethics committee reference number
893/13
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute Ischaemic Heart Disease
Primary outcomes
1
Description
incidence of arrhythmia
Timepoint
on arrival to hospital
Method of measurement
EKG analysis in hospital
Secondary outcomes
1
Description
Mortality rate
Timepoint
a week and a month later
Method of measurement
Death rate during a month after the internention
Intervention groups
1
Description
Amiodarone, 100mg, IV, in 10 minutes or more before admission to the hospital
Category
Treatment - Drugs
2
Description
Distilled water as placebo, with the same volume and shape as amiodarone, in 10 minutes or more, before admission to the hospital
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Emergency and Disaster Managment Center
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian Emergency and Disaster Managment Center
Full name of responsible person
Dr Nader Tavakoli
Street address
Jomhury ave.Iranian emergency research center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Emergency and Disaster Managment Center
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Iran Univercity of Medical Sciences
Full name of responsible person
Dr Maziar Morady
Street address
Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Univercity of Medical Sciences
Proportion provided by this source
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
Iran University Of Medical Sciences
Full name of responsible person
Dr Milad Salimi
Position
Emergency Medicine Resident
Other areas of specialty/work
Street address
Rasoul Akram Hospital
City
Tehran
Postal code
Phone
+98 912 694 2314
Fax
Email
miladsalimi_ed_med@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Ali Bidary
Position
Rheumatologist
Other areas of specialty/work
Street address
Rasool Akram Hospital
City
Tehran
Postal code
Phone
+98 912 327 7847
Fax
Email
emdaxb@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)