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A clinical trial to compare the effectiveness of remote ischemic preconditioning and primary coronary percutaneous intervention on cardiovascular outcomes in patients with acute myocardial infarction

Protocol summary

Study aim
A clinical trial to compare the effectiveness of remote ischemic preconditioning and primary coronary percutaneous intervention on cardiovascular outcomes in patients with acute myocardial infarction.
Design
In this pragmatic double-blind, controlled clinical trial, sixty patients with acute myocardial infarction were assigned into parallel groups using the table of random numbers in a community-based setting.
Settings and conduct
Patients with acute myocardial infarction at the Department of Cardiology, Ghaem Hospital, Mashhad, Iran, were chosen. In this double-blind study, the clinical care and data collector were blind to group assignment and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age higher than 20 years; an elapse of 12 hours form the primary diagnosis. Exclusion criteria: Thrombolysis in myocardial infarction (TIMI) score of 2-3; Rentrop grade of >1; need for coronary artery bypass graft; cardiogenic shock.
Intervention groups
The intervention group will receive remote ischemic preconditioning. In this method, a blood pressure cuff is fastened on one of the patient's organs before surgery, and the cuff is intermittently blown and drained to restrict blood flow and reestablish it. The control group will receive primary coronary percutaneous intervention. In this method, a tube with a balloon at the end, called the catheter, is moved into the coronary artery toward the blockage. After the dilatation of the vessel, the balloon is evacuated, and the catheter is pulled out.
Main outcome variables
Evaluation and comparison of major adverse cardiovascular events (mortality, second myocardial infarction, etc), the reduction of ST-segment as an indicator of microvascular reperfusion, thrombolysis in myocardial infarction flow, and cardiac enzymes before and 24 hours after the intervention in the intervention and control groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150614022713N2
Registration date: 2018-11-29, 1397/09/08
Registration timing: prospective

Last update: 2018-11-29, 1397/09/08
Update count: 0
Registration date
2018-11-29, 1397/09/08
Registrant information
Name
Masoud Sajadi
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 0000
Email address
sajjadim961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of remote ischemic preconditioning and primary coronary percutaneous intervention on cardiovascular outcomes in patients with acute myocardial infarction
Public title
The effect of remote ischemic preconditioning in patients with acute myocardial infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age higher than 20 years An elapse of 12 hours form the primary diagnosis
Exclusion criteria:
Thrombolysis in myocardial infarction (TIMI) score of 2-3 Rentrop grade of >1 Need for coronary artery bypass graft Cardiogenic shock
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty patients with acute myocardial infarction at the Department of Cardiology in Ghaem Hospital, Mashhad, Iran, were chosen. The participants were allocated into two groups of intervention and control using the table of random numbers based on computer programs.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with acute myocardial infarction at the Department of Cardiology, Ghaem Hospital, Mashhad, Iran, were chosen. In this double-blind study, the clinical care and data collector were blind to group assignment and the type of treatment.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research, Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.340

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
Major adverse cardiovascular events (i.e., mortality, second myocardial infarction, and stroke during admission)
Timepoint
Before and 24 hours after the intervention
Method of measurement
Echocardiography

2

Description
The reduction of ST-segment as an indicator of microvascular reperfusion
Timepoint
Before and 24 hours after the intervention
Method of measurement
Electrocardiogram (ECG)

3

Description
Thrombolysis in myocardial infarction flow
Timepoint
Before and 24 hours after the intervention
Method of measurement
Thrombolysis in Myocardial Infarction (TIMI) flow

Secondary outcomes

1

Description
Cardiac enzymes
Timepoint
Before and 24 hours after the intervention
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group: The intervention group will receive remote ischemic preconditioning. In this method, a blood pressure cuff is fastened on one of the patient's organs before surgery, and the cuff is intermittently blown and drained to restrict blood flow and reestablish it.
Category
Treatment - Other

2

Description
Control group: The control group will receive primary coronary percutaneous intervention. In this method, a tube with a balloon at the end, called the catheter, is moved into the coronary artery toward the blockage. After the dilatation of the vessel, the balloon is evacuated, and the catheter is pulled out.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Masoud Sajjadi
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
sajjadim961@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Sajjadi
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sajjadim961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Sajjadi
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sajjadim961@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Sajjadi
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Imam Reza Hospital, Imam Reza Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sajjadim961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Masoud Sajjadi provides the analysis code to the applicants via email: sajjadim961@mums.ac.ir
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.
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