Comparison of Outcomes following Deferred Versus Immediate Stenting in Patient with ST Elevation Myocardial Infarction Admitted to Emergency Department of Heshmat Hospital at 2015 - 2016
This study will be conducted on 57 patients with acute myocardial infarction with elevated ST. Inclusion criteria: the duration of symptoms more than six hours, anomalies of involved coronary artery including blocked artery in primary angiography primary perfusion, high volume of thrombosis, high length of lesion (more than 24 mm) , small diameter of vessels (less than 5.2 mm), and exclusion criteria include the lack of normal coronary flow. Patients will be given common treatment includes aspirin 300 mg and clopidogrel 600 mg and heparin 5,000 units on admission. After the restoration of blood flow the informed consent of patients will be taken. Background and clinical variables, including diabetes, hypertension and will be measured. The subjects were randomly allocated into two groups using block randomization. The first group which is characterized by the Code A, stenting will be done is performed immediately after common treatment. In Group B (Group deferred or delayed) stenting will be done at least 12 to 168 hours after the initial treatment. 12 to 168 hours interval time has been selected based on the intravenous treatment time necessity and the patient's condition and the patients of deferred group will receive all treatment protocols for delayed group including inhibitor of glycoprotein IIb / IIIa intravenous infusion and subcutaneous injection of enoxaparin for 24 hours. Blood pressure, electrocardiography and clinical symptoms during procedure and before stenting will be monitored. After completing PCI, patients undergoing secondary preventive common treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015120125327N1
Registration date:2016-01-10, 1394/10/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-10, 1394/10/20
Registrant information
Name
Majid Chinicar
Name of organization / entity
Guilan University of Medical Sciensec
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
m_chinicar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Guilan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Outcomes following Deferred Versus Immediate Stenting in Patient with ST Elevation Myocardial Infarction Admitted to Emergency Department of Heshmat Hospital at 2015 - 2016
Public title
The outcomes of immediate and deferred stenting in primary angioplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the duration of symptoms more than six hours, anomalies of involved coronary artery including blocked artery in primary angiography primary perfusion (TIMI0.1) , high volume of thrombosis, high length of lesion (more than 24 mm , small diameter of vessels (less than 5.2 mm ) , clinical signs of acute injury of micro-vascular after primary perfusion (with increasing ST more than 50%)
Exclusion criteria include the lack of normal coronary flow (TIMI3) after primary perfusion treatment with thrombus aspiration with or without balloon angioplasty, cardiogenic shock and inability to obtain informed consent.
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
57
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Next to Iran Radiator Building, Gaz Square, Rasht
City
Rasht
Postal code
Approval date
2015-11-15, 1394/08/24
Ethics committee reference number
IR.GUMS.REC.13940329
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21.0 , I2
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
no/slow reflow
Timepoint
In the first group (immediate) measured immediately after angiography
Method of measurement
By Echocardiography.This outcome has three degrees : lack of blood flow (TIMI0), incomplete filling (TIMI1), establish low blood flow but with complete filling (TIMI2) in involved coronary artery during or at the end of PCI
Secondary outcomes
1
Description
The consequences of electrocardiographic
Timepoint
One hour after treatment compared _ basic ECG, before reperfusion
Method of measurement
By electrocardiogram Complete resolution of ST elevation 70% <, relative 30-70% or non-occurrence > 30 %
2
Description
The consequences of Angiographic
Timepoint
At the end of the first procedure as prospective
Method of measurement
By Angiography, stent dimensions are compared with real stent at the second procedure by the same operator
3
Description
The consequences of Echocardiography
Timepoint
Before the first procedure and discharge
Method of measurement
Based on wall motion score index
Intervention groups
1
Description
Stenting immediately after treatment with aspirin 300 mg and clopidogrel 600 mg heparin 5000 U
Category
Treatment - Surgery
2
Description
Deferred Group: stenting at least 12 to 168 hours after the primary treatment
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Dr Majid Chinicar
Street address
Heshmat Hospital, 15 khordad St. , Rasht, Guilan, Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh (Specialist)
Street address
Next to Iran Radiator Building, Gaz Square, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Nozar Sotoudeh Foumani
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Heshmat Hospital, 15 khordad St. , Rasht, Guilan, Iran
City
Rasht
Postal code
Phone
+98 911 933 0305
Fax
Email
sepehrsaghari67@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Majid Chinicar
Position
Interventional Fellowship
Other areas of specialty/work
Street address
Heshmat Hospital, 15 khordad St. , Rasht, Guilan, Iran
City
Rasht
Postal code
Phone
+98 13 3366 3070
Fax
Email
mchinikar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Nozar Sotoudeh Foumani
Position
Resident of Cardiology
Other areas of specialty/work
Street address
Heshmat Hospital, 15 khordad St. , Rasht, Guilan, Iran
City
Rasht
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)