The aim of this study was to assess the effect of oxygen in induction of preconditioning in patient undergoing angioplasty. In this singLe blind study, the patients were randomly divided in two groups interventional and control group. Thus interventional group deliver oxygen 2 hour before and 12 hour after angioplasty with re-breathing mask with flow of 8 liter/minute and after the angioplasty wite measure the result by cardiac enzyme such troponin and creatine kinase and chest pain . include criteria؛ one vessel with 70% stenosis- exclude criteria ؛deliver of oxygen in past 3 days ؛ chest pain in past 3 days ؛ COPD disease ؛ prinzmental disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081114068N2
Registration date:2013-10-11, 1392/07/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-10-11, 1392/07/19
Registrant information
Name
Asghar Mohamadi
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 2529 3204
Email address
asgharems115@yahoo.com
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oxygen in induce Preconditioning in patient undergoing Angioplasty
Public title
Reducecardiac cell injury in angioplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria ؛ patient who have one coronary vessele wite 70% stenosis-
Exclusion criteria ؛ patient who have deliver of oxygen in past 3 days ؛ patient who have chest pain in past 3 days ؛ patient who have copd disease ؛ patient who have prinzmetal disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Moalem Ave,Lorestan University of Medical Sciences, khoramabad
City
khoramabad
Postal code
6814993165
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
200/82204
Health conditions studied
1
Description of health condition studied
angioplasty
ICD-10 code
I21
ICD-10 code description
myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset
Primary outcomes
1
Description
troponin ensyme
Timepoint
2 houer befor and 12 houer aftre
Method of measurement
with ramp aperatus
2
Description
ckmb ensyme
Timepoint
2 houer befor and 12 houer aftre
Method of measurement
with ramp aperatus
3
Description
crp protein
Timepoint
2 houer befor and 12 houer aftre
Method of measurement
aglutination way
Secondary outcomes
1
Description
chest pain
Timepoint
imediatly after defflation balloon
Method of measurement
with number pain from 0 -10
Intervention groups
1
Description
in interventional group oxygen deliver with rebreathing mask by 8 liter/minute with fio2 70 % in 2 houer befor and 12 houer after
Category
Treatment - Drugs
2
Description
in control group no deliver any medication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Hospital
Full name of responsible person
Asghar Mohamadi
Street address
khirabad Ave،Hospital Madani , Khoramabad
City
Khoramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Shahin Raoofi
Street address
Khirabad Ave,Madani Hospital, Khoramabad
City
Khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Shahin Raoofi
Position
MSC
Other areas of specialty/work
Street address
Khirabad Ave,Madani Hospital, Khoramabad
City
Khoramabad
Postal code
6814993165
Phone
+420 0134
Fax
Email
SHAHINRAOOFI@YAHOO.COM
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Asghar Mohamadi
Position
student of nursing
Other areas of specialty/work
Street address
Khirabad Ave,Madani Hospital, Khoramabad
City
Khoramabad
Postal code
6963145777
Phone
+52 93204
Fax
Email
ASGHAREMS115@YAHOO.CON
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Asghar Mohamadi
Position
student of nursing
Other areas of specialty/work
Street address
Khirabad Ave,Madani Hospital , Khoramabad
City
Khoramabad
Postal code
6963154777
Phone
+52 93204
Fax
Email
ASGHAREMS115@YAHOO.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)