Effect of high dose atorvastatin within 24 hours before elective percutaneous coronary intervention on periprocedural myocardial infarction in patients treated at Imam Khomeini hospital between September 2010 to March 2010
This study aimed to investigate the effect of high dose atorvastatin (80 mg) in reducing the Post-procedural MI following coronary angioplasty. In this triple-blind controlled randomized clinical trial, 190 adult candidates for elective PCI will be randomly assigned to receive high dose atorvastatin (80 mg) or placebo 24 hours before the procedure. Serum levels of creatinine kinase myocardial isoenzyme (CK-MB) and cardiac troponin I (cTNI) will be measured at baseline and then 6 and 12 hours following PCI to assess the incidence of MI. Post-procedural MI is defined as a CK-MB elevation >3 folds alone or associated with chest pain or ST segment or T wave abnormalities. In the statistical analysis, the relationship of myocardial infarction with the study variables and its incidence between the groups will be compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205209768N1
Registration date:2012-08-16, 1391/05/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-16, 1391/05/26
Registrant information
Name
Akbar Shafiee
Name of organization / entity
Tehran Heart Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9256
Email address
shafiee@leydenacademy.nl
Recruitment status
Recruitment complete
Funding source
Imam Khomeini hospital, Tehran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of high dose atorvastatin within 24 hours before elective percutaneous coronary intervention on periprocedural myocardial infarction in patients treated at Imam Khomeini hospital between September 2010 to March 2010
Public title
Effect of high dose atorvastatin in preventing myocardial infarction following coronary angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for elective coronary angioplasty with stable angina at Imam Khomeini hospital.
Exclusion criteria::
1- Previous CABG
2- Need for emergency primary PCI (<2 hours)
3- Renal dysfunction
4- Hypersensitivity to statins
5- History of PCI
6- Histoty of valvular disease (regurgitation =>3+ or stenosis > 2 cm2
7- serum creatinine > 1.2 mg/dl
8- History of liver dysfunction or rise of hepatic aminotransferases>3 folds
9- ejection fraction<30%
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Khoemini hospital, tehran University of MEdical Sciences
Street address
Keshavarz Blvd, Dr. Gharib st.
City
Tehran
Postal code
Approval date
2010-05-28, 1389/03/07
Ethics committee reference number
23/586/89
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
I121
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Myocardial infarction
Timepoint
6 & 12 hours after angioplasty
Method of measurement
Serum levels of CK-MB and Troponin I
Secondary outcomes
empty
Intervention groups
1
Description
80 mg oral atorvastatin within 24 hours before PCI
Category
Treatment - Drugs
2
Description
80 mg oral placebo within 24 hours before PCI
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Reza Rahmani MD
Street address
Keshavarz blvd, Dr. Gharib st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Imam Khomeini hospital, Tehran University of MEdical Sciences
Full name of responsible person
Reza Rahmani
Street address
Keshavarz blvd, Dr. Gharib st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Imam Khomeini hospital, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali pasha Meisami
Position
Social and preventive medicine
Other areas of specialty/work
Street address
Keshavarz blvd, Dr. Gharib st
City
Tehran
Postal code
Phone
+216 6404377
Fax
Email
meysamie@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khoemini Hospital, Tehran University of medical sciences
Full name of responsible person
Reza Rahmani
Position
Cardiologist
Other areas of specialty/work
Street address
Keshavarz blvd, Dr. Gharib st
City
Tehran
Postal code
Phone
+216 6404377
Fax
Email
r_rahmani@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Latifeh Nafasi
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Keshavarz blvd, Dr. Gharib st
City
Tehran
Postal code
Phone
+216 6404377
Fax
Email
Latifehnafasi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)