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Comparison of the effectiveness of over-sized stenting versus conventional stenting in patients undergoing primary percutaneous coronary intervention

Protocol summary

Study aim
Evaluation of over-size stenting in patient with acute myocardial infarction undergoing primary percutaneous coronary intervention
Design
Single blinded parallel group randomized controlled trial
Settings and conduct
The trial will be held in a hospital setting. Patients will be randomized via central web based method into the interventional group (oversized stenting) and control group (conventional stenting) Patients will be blinded. Stenting outcome after the procedure and 6 months later will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with acute ST elevation myocardial infarction who undergoing primary percutaneous coronary intervention. Exclusion criteria: Primary percutaneous coronary intervention without stenting, on saphenus vein graft, on stent thrombosis and in rescue setting and unable to measure ST resolution.
Intervention groups
In interventional group, after diagnostic angiography, intracoronary nitroglycerin will be injected and infarcted vessel size in the proximal and distal section was measured by quantitative coronary analysis system . Then considering average of vessel diameter and operator decision the size of stent was chosen and 10% oversizing was done.In control group, after after diagnostic angiography, intracoronary nitroglycerin will be injected and infarcted vessel size in the proximal and distal section was measured by quantitative coronary analysis system . Then considering average of vessel diameter and operator decision the size of stent was chosen but it will not be oversized.
Main outcome variables
primary outcome: cardiac enzyme, ST-segment resolution, No-reflow phenomenon, Hospital stay days Secondary outcome: Target vessel revascularization,Target lesion, revascularization, Reinfarction, All cause mortality, Cardiovascular mortality Congestive heart failure, Cerebrovascular accident

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190411043242N1
Registration date: 2019-08-29, 1398/06/07
Registration timing: retrospective

Last update: 2019-08-29, 1398/06/07
Update count: 0
Registration date
2019-08-29, 1398/06/07
Registrant information
Name
Ata Firouzi
Name of organization / entity
Shahid Rajaei Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 23921
Email address
atafirouzi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-03-19, 1397/12/28
Trial completion date
2019-09-22, 1398/06/31
Scientific title
Comparison of the effectiveness of over-sized stenting versus conventional stenting in patients undergoing primary percutaneous coronary intervention
Public title
Over-sized stenting in primary percutaneous coronary intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute myocardial infarction with >0.1 mV ST-segment elevation from baseline in at least two contiguous leads on the 12-lead electrocardiogram who were candidate for primary percutaneous intervention
Exclusion criteria:
Primary percutaneous coronary intervention without stenting Primary percutaneous coronary intervention of saphenus vein graft Rescue Primary percutaneous coronary intervention stent thrombosis myocardial infarction Electrocardiogram data inadequate to measure ST resolution
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 94
Actual sample size reached: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed via permuted block randomization method. Allocation will be generated via a web based system and consequently concealment will be central using computer software. Unit of randomization will be individual patients and no stratification will be applied
Blinding (investigator's opinion)
Single blinded
Blinding description
Only participant in this study were be blinded
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Rajaie Cardiovascular, Medical & Research Center
Street address
Hashemi Rafsanjani highway, Valiasr street
City
Tehran
Province
Tehran
Postal code
199691151
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.RHC.REC.1398.020

Health conditions studied

1

Description of health condition studied
Patient with acute myocardial infarction undergoing primary coronary angioplasty
ICD-10 code
I21.3
ICD-10 code description
ST elevation (STEMI) myocardial infarction of unspecified site

Primary outcomes

1

Description
cardiac enzyme level
Timepoint
twelve hours after procedure
Method of measurement
Lab kit

2

Description
ST segment resolution
Timepoint
60 minute after procedure
Method of measurement
electrocardiogram

3

Description
No Reflow phenomenon
Timepoint
after stent implantation
Method of measurement
angiography

4

Description
hospital stay
Timepoint
hospital course
Method of measurement
patient profile

Secondary outcomes

1

Description
target vessel revascularization
Timepoint
six months after intervention
Method of measurement
Medical record

2

Description
Reinfarction
Timepoint
six months after intervention
Method of measurement
Medical record

3

Description
cardiovascular death
Timepoint
six months after intervention
Method of measurement
Medical record

4

Description
all cause death
Timepoint
six months after intervention
Method of measurement
Medical record

5

Description
congestive heart failure
Timepoint
six months after intervention
Method of measurement
Medical record

6

Description
cardiovascular accident
Timepoint
six months after intervention
Method of measurement
Medical record

Intervention groups

1

Description
Intervention group: oversized stenting. In interventional group, after diagnostic angiography, intracoronary nitroglycerin will be injected and infarcted vessel size in the proximal and distal section was measured by quantitative coronary analysis system . Then considering average of vessel diameter and operator decision the size of stent was chosen and 10% oversizing was done.
Category
Treatment - Other

2

Description
Control group: Nonoversized sternting. In control group, after after diagnostic angiography, intracoronary nitroglycerin will be injected and infarcted vessel size in the proximal and distal section was measured by quantitative coronary analysis system . Then considering average of vessel diameter and operator decision the size of stent was chosen but it will not be oversized.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaie cardiovascular medical and research center
Full name of responsible person
Seyyed Ali Banifatemeh
Street address
Hashemi Rafsanjani highway, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2266 3249
Email
Banifatemeh_cardio@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Seyyed Ali Banifatemeh
Street address
Hashemi Rafsanjani highway, valiasr street
City
Tehran
Province
Tehran
Postal code
996911151
Phone
+98 21 2266 3249
Email
Banifatemeh_cardio@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rajaie Cardiovascular Medical and Research center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Seyyed Ali Banifatemeh
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Hashemi Rafsanjani highway, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2266 3249
Email
Banifatemeh_cardio@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Firouzi Ata
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Rajaie cardiovascular medical and research center
Street address
Hashemi Rafsanjani highway, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2266 3249
Email
atafirouzi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rajaie cardiovascular medical and research center
Full name of responsible person
Seyyed Ali Banifatemeh
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Rajaie cardiovascular medical and research center
Street address
Hashemi Rafsanjani highway, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996911151
Phone
+98 21 2266 3249
Email
Banifatemeh_cardio@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Unavailability of resources
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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