Protocol summary

Study aim
Determining the effect of Remote Ischemic Preconditioning(RIC) on the incidence of cardiovascular major complications in patients with acute myocardial infarction with ST-segment elevation(STEMI)
Design
Study of single-blind randomized clinical trial with STEMI patients and Primary percutaneous coronary intervention candidates in both intervention and control groups 80 patients in the intervention group and 80 patients in the control group based on consecutive sampling and having inclusion criteria based on four random blocks whose sequence by Sealed Envelope software block randomization specified, will be reviewed.
Settings and conduct
Patients who are referred to the emergency department of Heshmat Hospital due to STEMI. Patients in the intervention group, before PCI, undergo Ischemic Preconditioning Remote in such a way that their upper limbs are subjected to ischemia 3 times with a pressure cuff of 30 mmHg above systolic pressure and each time for 5 minutes They are stretched and then emptied for 5 minutes. However, in the control group, only the pressure gauge cuff is closed. Finally, the information obtained is recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years of age with chest pain and onset of pain less than 12 hours and ECG with ST-elevation equal or higher than0.1mv in two leads together Exclusion criteria: cardiogenic shock. dying before or immediately after . past myocardial infarction or vascular bypass surgery. 12 hours or more have elapsed since the onset of maximal chest pain.
Intervention groups
Patients referred due to STEMI are included in the study and the RIC procedure is performed on patients in the case group.
Main outcome variables
LVEF; stroke; Myocardial reinfarction; New heart failure; Death

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200510047380N2
Registration date: 2022-01-29, 1400/11/09
Registration timing: registered_while_recruiting

Last update: 2022-01-29, 1400/11/09
Update count: 0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
Aboozar Fakhr Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 4282
Email address
aboozar.mousavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on effects of ischemic preconditioning on the occurrence rate of major cardiovascular complications in patients suffering from acute myocardial infraction with ST segment elevation
Public title
The effect of ischemic preconditioning in patients with acute Myocardial infraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 coming into the emergency room because of chest pain that has started less tan 12 hours before ECG shows ST elevation equaling or higher than 0/1 mill volt in two parallel leads(ST elevation equals or is higher than 0/2 mill volt in v1 to v3 leads)
Exclusion criteria:
Patients in cardiogenic shock Patients who die before or immediately after percutaneous coronary intervention(PCI) Patients with a history of myocardial infarction or coronary artery bypass graft 12 hours or more have elapsed since the onset of maximal chest pain
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Investigator
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
According to the estimated sample size, 80 patients in the intervention group and 80 patients in the control group based on consecutive sampling and having inclusion criteria based on four random blocks whose sequence by Sealed Envelope software Ltd.2021.Created a block Randomisation list {Online} Available from: https://www.sealedenvelope.com/simple -randomiser / v1 / lists {Accessed 13 Sep 2021} The list is kept inside a sealed letter at the Healthy Heart Research Center. After permission to conduct the study, patients are assigned to the intervention and control groups on a daily basis. It should be noted that this sequence list consists of 40 quadruple random blocks. This study is a single-blind clinical trial study. The method of blinding in the study will be that the intervention of patients by one of the assistants and the evaluation of complications and measurement of left ventricular ejection fraction by another assistant. Patients have no information about the type of intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blind clinical trial. the independent variable in this study is the intervention group against control group, the outcomes of this study(heart failure, recurring myocardial infraction, stroke and death) are the primary end points , and ejection fraction(EF) is the secondary end point.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Guilan university of medical sciences
Street address
Dr Heshmat Hospital, mosalla Square, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193955588
Approval date
2021-09-29, 1400/07/07
Ethics committee reference number
IR.GUMS.REC.1400.308

Health conditions studied

1

Description of health condition studied
ST segment elevation acute myocardial infraction
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified

Primary outcomes

1

Description
Patients with acute ST-segment elevation myocardial infarction
Timepoint
Before the intervention and 3 months later and 6 months after acute myocardial infarction
Method of measurement
Based on electrocardiogram tape

Secondary outcomes

1

Description
Heart failure, recurrent myocardial infarction, stroke and death, left ventricular ejection fraction
Timepoint
Before the intervention, 3 months later and 6 months later
Method of measurement
Through a researcher-made questionnaire and echocardiography device

Intervention groups

1

Description
Patients with acute myocardial infarction with ST-segment elevation who are candidates for Primary PCI and undergo RIC. The cuff is placed on one of the upper limbs and inflated to 30 mm/hg higher than systolic pressure for a period of 5 minutes. The process is repeated 3 times with a 5-minute interval.
Category
Rehabilitation

2

Description
Control group: Patients with acute myocardial infarction with ST-segment elevation who were candidates for Primary PCI. The cuff is placed on one of the upper limbs and inflated to 30 mm/hg higher than systolic pressure for a period of 5 minutes. The process is repeated 3 times with a 5-minute interval.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Seyyed Aboozar Fakhr Mousavi
Street address
Dr Heshmat Hospital, Mosalla square, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 3070
Email
aboozar-fm@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Naghi Pour
Street address
Dr Heshmat Hospital, Mosalla square, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 3070
Email
aboozar-fm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Seyyed Aboozar Fakhr Mousavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Dr Heshmat Hospital, Mosalla square
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 3070
Email
aboozar-fm@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyyed Aboozar Fakhr Mousavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Dr Heshmat Hospital, Mosalla square
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 3070
Email
aboozar-fm@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Seyyed Aboozar Fakhr Mousavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Dr Heshmat Hospital, Mosalla square
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3366 3070
Email
aboozar-fm@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to conduct further research at the written request of the Scientific Institute.
From where data/document is obtainable
applicants for receiving documents and data can refer to the Healthy Heart Research Center located in Heshmat Hospital. They can also call 01333664282.
What processes are involved for a request to access data/document
The applicant can refer to the Healthy Heart Research Center after receiving Confirmation from the project manager, the documents and data will be available to him within a week.
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