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Determining the effectiveness of Remote Ischemic Postconditioning in the treatment of patients with ischemic stroke - Randomized Clinical trial

Protocol summary

Study aim
Determining the effectiveness of Remote Ischemic Postconditioning in the treatment of patients with ischemic stroke
Design
This study is a parallel triple-blind clinical trial on 160 patients with intervention and control group. Restricted randomization method will be used to allocate patients into intervention and control groups. The researcher has no information about the selection sequence of samples and the type of procedure performed which are done by the nurses and trained individuals.
Settings and conduct
Location: Poursina Hospital (Rasht, Iran). The patient, researcher, and evaluator are blinded and samples are randomly selected.
Participants/Inclusion and exclusion criteria
*Inclusion criteria: No dependence on care before the stroke and Modified Rankin Scale (MRS) <= 2; Presence of a CT SCAN or MRI indicating the occurrence of the stroke; National Institutes of Health Stroke Scale (NIHSS) between 5 and 15 at the beginning; Less than 24 hours interval between the occurrence of the stroke and the onset of Remote Ischemic Postconditioning (RIPC); Signed informed consent by patients or companions. *Non inclusion criteria: cerebral diseases; Previous brain surgery, hemorrhagic stroke or ischemic stroke in the last 3 months; Pregnancy, Severe comorbidity; Peripheral vascular disease, severe liver disease, history of chronic lung disease, liver disease, kidney disease; doctor's order.
Intervention groups
Group A (intervention group: patients undergoing RIPC with sphygmomanometer inflated up to 180 mmHg 5 minutes for 5 cycles with a 3 minute rest between cycles, at the admission); Group B (control group: patients undergoing same procedure with uninflated cuff).
Main outcome variables
1. NIHSS (National Institutes of Health Stroke Scale); 2. MRS (Modified Rankin Scale); 3.Clinical outcome; 4. Hospital stay

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211226053525N1
Registration date: 2022-01-22, 1400/11/02
Registration timing: prospective

Last update: 2022-01-22, 1400/11/02
Update count: 0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
Mozaffar Hosseininezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3332 2444
Email address
hosseininezhadm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-08-06, 1401/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of Remote Ischemic Postconditioning in the treatment of patients with ischemic stroke - Randomized Clinical trial
Public title
Determining the effectiveness of Remote Ischemic Postconditioning in the treatment of patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No dependence on care before the stroke and MRS score <= 2 Presence of a CT SCAN or MRI indicating the occurrence of the stroke National Institutes of Health Stroke Scale (NIHSS) score between 5 and 15 at the beginning Less than 24 hours interval between the occurrence of the stroke and the onset of RIPC Signed informed consent by patients or companions
Exclusion criteria:
Cerebral diseases such as intracranial aneurysm, vascular malformation and dementia Previous brain surgery, hemorrhagic stroke or ischemic stroke in the last 3 months Pregnancy Severe comorbidity (incurable disease, advanced cancer with low life expectancy, renal and hepatic failure, rheumatic diseases) Peripheral vascular disease, severe liver disease, history of chronic lung disease, liver disease, kidney disease, doctor's order
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups. For this purpose, four blocks with a ratio of 1: 1 will be considered. Sequences are marked in sealed envelopes with the letters A (intervention group) and B (control group). We will consider the size of the blocks randomly with a size of 4 or 6 to prevent the latest allocation from being detected. In the randomization process, random allocation sequences are identified by a statistician, and student collaborator in the project will register participants and allocate them to interventions.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to blind the subjects (patients) in the control group, the sphygmomanometer will be placed around patients' arm uninflated. In order to blind the researcher, allocators determine the groups without prior information using the allocation concealment method. The project will be performed based on patients groups by nurses or trained individuals. Final evaluation will be done by evaluators and physicians. In this study, restricted randomization method in the form of block randomization will be used to allocate patients into intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committees of Guilan University of Medical science
Street address
Guilan University of Medical science
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2021-12-15, 1400/09/24
Ethics committee reference number
IR.GUMS.REC.1400.446

Health conditions studied

1

Description of health condition studied
Ischemic stroke
ICD-10 code
I67.8
ICD-10 code description
Other specified cerebrovascular diseases

Primary outcomes

1

Description
National Institutes of Health Stroke Scale (NIHSS)
Timepoint
On admission, at discharge and on day 90
Method of measurement
Calculation of score through questionnaire and based on patient examination

2

Description
Modified Rankin Scale (MRS)
Timepoint
On admission, at discharge and on day 90
Method of measurement
Calculation of score through based on patient examination and scale

3

Description
Clinical outcome
Timepoint
at discharge
Method of measurement
Based on patients' files

4

Description
Hospital stay
Timepoint
at discharge
Method of measurement
Based on patients' files

Secondary outcomes

1

Description
Blood sugar
Timepoint
On admission, at discharge and on day 90
Method of measurement
Based on patient test results

2

Description
Blood pressure
Timepoint
On admission, at discharge and on day 90
Method of measurement
based on examination

3

Description
blood indices: Cell blood count (CBC), Prothrombin time (PT), The international normalized ratio (INR), Partial Thromboplastin Time (PTT)
Timepoint
On admission, at discharge and on day 90
Method of measurement
Based on patient test results

4

Description
Creatine kinase total
Timepoint
On admission, at discharge and on day 90
Method of measurement
Based on patient test results

5

Description
Creatinine (Cr)
Timepoint
On admission, at discharge and on day 90
Method of measurement
Based on patient test results

6

Description
Liver enzymes: Aspartate aminotransferase (AST) , Alanine transaminase (ALT)
Timepoint
On admission, at discharge and on day 90
Method of measurement
Based on patient test results

Intervention groups

1

Description
Intervention group: Remote Ischemic Postconditioning (RIPC) procedure will be performed on the first day of hospitalization under the following protocol: Sphygmomanometer will be attached to the patient's healthy arm and will be remained under the pressure of 180 (or 30mmHg more than patient's systolic BP if SBP>=180) mmHg for 5 minutes (ischemic phase) , followed by 3 minutes of rest (reperfusion phase). This cycle will be performed 5 times. All patients (both intervention group and control group) will receive the routine treatment in stroke management. The time from the onset of the stroke to RIPC should be less than 24 hours, with a golden time of 6 hours. The performance comparison of the two groups will be measured by National Institutes of Health Stroke Scale (NIHSS) and Modified Rankin Scale (MRS) criteria on days 0, discharge and 90. For biochemical measurements, the patient's serum will be sent to the laboratory and measured using routine methods.
Category
Treatment - Other

2

Description
Control group: RIPC procedure will be performed on the first day of hospitalization under the following protocol: Sphygmomanometer will be attached uninflated to the patient's healthy arm for 5 minutes , followed by 3 minutes of rest. This cycle will be performed 5 times. All patients (both intervention group and control group) will receive the routine treatment in stroke management. The time from the onset of the stroke to RIPC should be less than 24 hours, with a golden time of 6 hours. The performance comparison of the two groups will be measured by NIHSS and MRS criteria on days 0, discharge and 90. For biochemical measurements, the patient's serum will be sent to the laboratory and measured using routine methods.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina hospital
Full name of responsible person
Dr. Mozafar hosseininezhad
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3332 5783
Fax
+98 13 3333 9842
Email
hosseininezhadm@gmail.com
Web page address
https://poursina.gums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr.Mohammadreza Naghipour
Street address
Deputy of Research and Technology, in front of 17 Shahrivar Hospital, Namjoo St
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
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
Dr. Mozafar hosseininezhad
Position
Associate Professor of Neurology. Department of Neurology, School of Medicine. Neuroscience Research
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3332 5783
Email
hosseininezhadm@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mozafar hosseininezhad
Position
Associate Professor of Neurology. Department of Neurology, School of Medicine. Neuroscience Research
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3332 5783
Email
hosseininezhadm@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mozafar hosseininezhad
Position
Associate Professor of Neurology. Department of Neurology, School of Medicine. Neuroscience Research
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Namjoo street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3332 5783
Email
hosseininezhadm@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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