The effect of remote ischemic peri-conditioning in comparison to not performing it on electrocardiographic ST resolution in STEMI patients treated with thrombolytics
The major goal is the assessment the effect of remote ischemic peri-conditioning on electrocardiographic ST resolution in STEMI patients who were treated with thrombolytics. 80 patients with the first STEMI candidated for thrombolytics were recruited and randomly assigned to case and control groups. Peri-conditioning was done via 3 times intermittent inflation the cuff of sphygmomanometer 30 mmHg more than the systolic blood pressure in cases and 30 mmHg less than it in controls on the other hand of thrombolytic injection site. Patients with other ECG changes were excluded. ST resolution and cardiac enzymes were assessed. Patients and researchers were blind of randomization.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011916229N2
Registration date:2016-06-22, 1395/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-22, 1395/04/02
Registrant information
Name
Samad Ghaffari
Name of organization / entity
Cardiovascular Research Center, Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3576
Email address
ghafaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Tabriz University of Medical Sciences
Expected recruitment start date
2014-02-15, 1392/11/26
Expected recruitment end date
2015-02-15, 1393/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of remote ischemic peri-conditioning in comparison to not performing it on electrocardiographic ST resolution in STEMI patients treated with thrombolytics
Public title
The effect of limb ischemia on myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients 18- 80 yrs of age; with first acute MI; presenting within first 6 hours from symptom onset
Exclusion : LBBB; Pacemaker; cardioversion ; cardiogenic shock and those candidate for rescue PCI or emergency CABG
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St., Azadi Ave.
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
9319
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
121.0, 121
ICD-10 code description
Acute transmural myocardial infarction of anterior wall ;Acute transmural myocardial infarction of inferior wall
Primary outcomes
1
Description
ST Resolution
Timepoint
90 MIN
Method of measurement
ECG
Secondary outcomes
1
Description
Enzymatic Infarct Size
Timepoint
First 48 hrs ( every 12 hrs )
Method of measurement
Laboratory Analysis via routine cardiac enzymes kit
Intervention groups
1
Description
3 times inflation the cuff of sphygmomanometer 30 mmHg more than the systolic blood pressure
Category
Treatment - Devices
2
Description
3 times inflation the cuff of sphygmomanometer 30 mmHg less than the systolic blood pressure
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Heart Center
Full name of responsible person
Ghaffari Samad
Street address
Golbad St., Azadi Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Tabriz University of Medical Sciences
Full name of responsible person
Soleimanpur Hasan
Street address
Golgasht St., Azadi Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ghaffari Samad
Position
Full Professor of Cardiology
Other areas of specialty/work
Street address
Golgasht St., Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41 3336 4667
Fax
Email
ghafaris@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ghaffari Samad
Position
Full Professor of Cardiology
Other areas of specialty/work
Street address
Golgasht St., Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41 3336 4667
Fax
Email
ghafaris@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ghaffari Samad
Position
Full Professor of Cardiology
Other areas of specialty/work
Street address
Golgasht St., Azadi Ave.
City
Tabriz
Postal code
Phone
+98 41 3336 4667
Fax
Email
ghafaris@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)