Aim of this prospective randomizes controlled study is survey of post conditioning effect on early prognosis of ST- elevation myocardial infarction. Recruited patients (upon inclusion and exclusion criteria) divided to 15 person two groups randomizely. In patient group after the direct stenting, the angioplasty balloon was positioned just upstream of the implanted stent and reinflated 4 times for 1 minute with low-pressure (4 to 6 atm) inflations; each separated by 1 minute of reflow.this procedure called post conditioning and was not done in control group. Patients have been assessing by ECG and enzyme change from base line and serial echocardiography.
General information
Acronym
HHT
IRCT registration information
IRCT registration number:IRCT2012120211643N1
Registration date:2013-03-18, 1391/12/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-18, 1391/12/28
Registrant information
Name
Jamshid Sharifi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 1355 6349
Email address
jsharifi@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Science
Expected recruitment start date
2013-01-18, 1391/10/29
Expected recruitment end date
2014-01-19, 1392/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of post conditioning on the early prognosis of patient with acute ST-elevation myocardial infarction
Public title
post conditioning in Myocardial Infarction
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:typicall prolonged chest pain; ECG change(An ST elevation at least 1 mm in a limb lead or 2 mm in a precodial lead
exclusion criteria:cardiac arrest; cadiogenic shock; old myocardial infarction; pulmonary edema
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Hormozgan Hniversity of Medical Science
Street address
Vice and Chancellor for Research and Technology, Shahid Mohammadi Hospital, IR Street, Bandar Abbas
City
BandarAbbas
Postal code
Approval date
2012-12-17, 1391/09/27
Ethics committee reference number
91/01/633
Health conditions studied
1
Description of health condition studied
Acute Myocardial Infarction
ICD-10 code
I21
ICD-10 code description
Acute Myocardial Infarction
Primary outcomes
1
Description
ST elevation measurment
Timepoint
any 12 hr for 2 times then daily
Method of measurement
ECG
2
Description
serum ceratin kinas mb
Timepoint
any 12 h for 2 times then daily
Method of measurement
ELISA
3
Description
serum troponin I level
Timepoint
daily
Method of measurement
ELISA
4
Description
ejection fraction
Timepoint
daily
Method of measurement
Echocardiography
Secondary outcomes
1
Description
hyperlipidemia
Timepoint
one times in study
Method of measurement
ELISA
2
Description
smoking
Timepoint
one times in study
Method of measurement
history
3
Description
diabet melitus
Timepoint
one times in study
Method of measurement
history
4
Description
coronary site involvment
Timepoint
one times in study
Method of measurement
angiography
5
Description
hypertension
Timepoint
one times in study
Method of measurement
history
6
Description
arrytmia
Timepoint
full time of admission period
Method of measurement
herat monitoring
Intervention groups
1
Description
after the direct stenting, the angioplasty balloon was positioned just upstream of the implanted stent and reinflated 4 times for 1 minute with low-pressure (4 to 6 atm) inflations; each separated by 1 minute of reflow
Category
Treatment - Other
2
Description
after the direct stenting and angioplasty don't be other intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital
Full name of responsible person
Dr Jamshid Sharifi
Street address
Internal Ward, Shahid Mohammadi Hospital, IR Street, Bandar Abbas
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Dr Abdolazim Nejatizade
Street address
Vice and Chancellor for Research and Thecnology, Shahid Mohammadi Hospital, Bandarabbas
City
Bandarabbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Science
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
Hormozgan University of Medical Science
Full name of responsible person
Jamshid Sharifi
Position
Iinternal Resident
Other areas of specialty/work
Street address
Internal Ward, Shahid Mohammadi Hospital, IR Street, Bandar Abbas
City
Bandar Abbas
Postal code
Phone
+98 761
Fax
Email
jsharifi@hums.ac.irms_jamshid_sharifi@yahoo.com
Web page address
www.hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Dr Ahmad Noor Abdi
Position
Cardiologist, Interventionalist
Other areas of specialty/work
Street address
Cardiology Ward, Shahid Mohammadi Hospital, IR Street, Bandar Abbas
City
BandarAbbas
Postal code
Phone
+98 76 1335 4056
Fax
+98 33 54056
Email
ahmadnoorabdi@gmail.com
Web page address
www.hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Jamshid Sharifi
Position
Iinternal Resident
Other areas of specialty/work
Street address
Internal Ward, Shahid Mohammadi Hospital, IR Street, Bandar Abbas
City
Bandar Abbas
Postal code
Phone
+98 76 1335 4056
Fax
+98 33 54056
Email
jsharifi@hums.ac.irms_jamshid_sharifi@yahoo.com
Web page address
www.hums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)