The effect of cardiac remote ischemic preconditioning (IRPC) on the release of cardiac troponin I after elective percutaneous coronary intervention (PCI) in outpatients admitted to the angiography ward
Evaluation of the effect of cardiac ischemic preconditioning on the release of cardiac troponin I after elective percutaneous coronary intervention
Design
Single-blinded randomized controlled clinical trial, randomization by random allocation software, sample size of 240 patients (120 in each group), interventionist blinded to groups
Settings and conduct
Patients with CAD who are referred to Bandar Abbas Shahid Mohammadi Hospital by the attendings for elective PCI as outpatients, an hour before PCI undergo intervention (or no intervention) according to their grouping. Then PCI is performed on all patients by an interventionist blinded to the grouping and the PCI method is chosen by him according to the patients' conditions. Biochemical tests are also performed without knowledge of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age of 18 years or older
2. Stable coronary artery disease
3. Requirement of elective PCI (percutaneous coronary intervention)
Exclusion criteria:
1. Emergency PCI
2. Renal dysfunction
3. High level of cardiac troponin before PCI
4. Women of childbearing age
5. Use of Nicorandil or Glibenclamide
6. Severe comorbidities (terminal illnesses, advanced cancers with low life expectancy, renal and hepatic failure, rheumatic diseases)
Intervention groups
An hour before PCI, in the RIPC group a pressure cuff is inflated on the non-dominant arm to 200 mm/Hg for 5 minutes and then it is deflated after 5 minutes. This cycle is repeated 2 more times. Patients in the control group have a deflated cuff placed on their non-dominant arm for 30 minutes and no inflation-deflation is performed.
Main outcome variables
CKMB; Troponin I, GFR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180306038978N1
Registration date:2019-05-28, 1398/03/07
Registration timing:retrospective
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Shoeib Paskhandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3331 0012
Email address
shoeibpaskhandi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cardiac remote ischemic preconditioning (IRPC) on the release of cardiac troponin I after elective percutaneous coronary intervention (PCI) in outpatients admitted to the angiography ward
Public title
The effect of cardiac remote ischemic preconditioning (IRPC) on the release of cardiac troponin I after elective percutaneous coronary intervention (PCI)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 years or older
Stable coronary artery disease
Requirement of elective PCI
Exclusion criteria:
Emergency PCI
Renal dysfucntion
High cardiac troponin levels before PCI
Women of childbearing age
Use of Nicorandil or Glibenclamide
Severe comorbidities (terminal illnesses, advanced cancers with low life expectancy, renal failure, hepatic failure, rheumatic diseases)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were randomized into two groups by means of a randomization table acquired from the Random Allocation software. for example:
0001: Control 0041: Case 0081: Case 0121: Case 0161: Control 0201: Case
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hormozgan University of Medical Sciences
Street address
Jomhouri Eslami Blvd, Shahid Mohammadi Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
HUMS.REC.1396.93
Health conditions studied
1
Description of health condition studied
Ischemic heart disease
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Cardiac troponin I
Timepoint
Cardiac troponin I is measured right before and 18 hours after percutaneous coronary intervention
Method of measurement
Quantitative measurement of cardiac troponin I using enzymatic method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: An hour before percutaneous coronary intervention a blood pressure cuff will be placed around the non-dominant arm of the patients, then it will be inflated up to 200 mmHg for 5 minutes, afterwards the cuff will be deflated for 5 minutes and this cycle will be repeated two more times.
Category
Prevention
2
Description
Control group: An hour before percutaneous coronary intervention deflated blood pressure cuff will be placed on the non-dominant arm of the patients for 30 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Catheterization laboratory of Shahid Mohammadi Hospital
Full name of responsible person
Shoeib Paskhandi
Street address
Shahid Mohammadi Hospital, Jomhouri Eslami Blvd, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3334 7000
Fax
+98 76 3334 5003
Email
shmh@hums.ac.ir
Web page address
http://www.shmh.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Hossein Farshidi
Street address
Bandar Abbas Faculty of Medicine, Imam Hossein Blvd., Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0370
Fax
+98 76 3371 0371
Email
hums@hums.ac.ir
Web page address
http://www.medf.hums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shoeib Paskhandi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Bandar Abbas Faculty of Medicine, Imam Hossein Blvd., Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0370
Fax
+98 76 3371 0371
Email
hums@hums.ac.ir
Web page address
http://www.medf.hums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shoeib Paskhandi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Bandar Abbas Faculty of Medicine, Imam Hossein Blvd., Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0370
Fax
+98 76 9971 0371
Email
hums@hums.ac.ir
Web page address
http://www.medf.hums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shoeib Paskhandi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Bandar Abbas Faculty of Medicine, Imam Hossein Blvd., Bandar Abbas, Hormozgan, Iran
City
Bandar Abbas
Province
Hormozgan
Postal code
7919693116
Phone
+98 76 3371 0370
Fax
+98 76 3371 0371
Email
hums@hums.ac.ir
Web page address
http://www.medf.hums.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Primary outcome and demographic data
When the data will become available and for how long
Starting 1 year after publication of the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Only analyses not indicated in the published article are allowed.
From where data/document is obtainable
Applicants can use the following email address to submit their requests and an SPSS data file will be available to them.
shoeibpaskhandi@yahoo.com
What processes are involved for a request to access data/document
Valid identification card indicating that the applicant is a member of academic institutions