Effects of cardiac rehabilitation on C-reactive protein, neutrophil-to-lymphocyte, and platelet-to-lymphocyte ratio in unstable ischemic heart disease patients following percutaneous coronary intervention: A randomized clinical trial
Evaluating inflammatory markers ( including c reactive protein ( CRP) , neutrophil to lymphocyte ratio (NLR) , and platelet to lymphocyte ration (PLR) ) after cardiac rehabilitation (CR) in patient with unstable ischemic heart disease (UIHD) who underwent successful percutaneous coronary intervention (PCI).
Design
Single center , two groups :the control ( n=40) and the CR ( cardiac rehabilitation , n =80 ) group, permuted block stratified randomization, double arm randomized control trial, parallel design, randomization with computer software. Due to the nature of the intervention it was not possible to blind either the patients or the care givers.
Settings and conduct
The study was performed at Tehran Heart Center Hospital. Blood sample is taken form patients before discharge from the hospital (patients were hospitalized due to PCI) and the variables of interest were measured. 12 weeks later, during which time the intervention group underwent cardiac rehabilitation and routine care after PCI and the control group received only routine care, blood samples are taken again. The person taking the samples and entering the information and the person performing the analysis was blind to the group of patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria : all >18 years patients with unstable ischemic heart disease (UIHD) with negative cardiac enzymes who had undergone successful PCI . Exclusion: Patients aged >70 or with uncontrolled diseases or previous cardiac interventions or other concomitant cardiac diseases
Intervention groups
The cardiac rehabilitation program included once-a-week supervised aerobic exercise sessions and educational sessions for 12 weeks. In the latter, patients were ducated about various lifestyle modifications.
Main outcome variables
Blood inflammatory markers after 12 weeks of cardiac rehabilitation :
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210827052304N2
Registration date:2022-12-03, 1401/09/12
Registration timing:retrospective
Last update:2022-12-03, 1401/09/12
Update count:0
Registration date
2022-12-03, 1401/09/12
Registrant information
Name
Mana Jameie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
jameie.mana@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-01, 1396/10/11
Expected recruitment end date
2020-09-01, 1399/06/11
Actual recruitment start date
2018-01-01, 1396/10/11
Actual recruitment end date
2020-09-01, 1399/06/11
Trial completion date
2020-12-01, 1399/09/11
Scientific title
Effects of cardiac rehabilitation on C-reactive protein, neutrophil-to-lymphocyte, and platelet-to-lymphocyte ratio in unstable ischemic heart disease patients following percutaneous coronary intervention: A randomized clinical trial
Public title
Effect of cardiac rehabilitation on inflammatory markers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All > 18 years patients with unstable ischemic heart disease (UIHD) with negative enzymes who had undergone successful percutaneous coronary intervention (PCI)
Informed consent
Exclusion criteria:
Age > 70 years
History of dysrhythmia
History of decompensated heart failure
History of coronary artery bypass graft (CABG)
History of myocardial infarction
Uncontrolled hypertension
Uncontrolled diabetes mellitus,
Physical disability
History of respiratory dysfunction
History of cerebrovascular diseases
History of severe valvular heart diseases
History of any known inflammatory diseases other than atherosclerosis
Ongoing clinical infection
Planned surgery within the next four months
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated in the two groups by permuted
stratified randomization technique ( ratio 2:1 , for each control patient we enrolled 2 cases in the intervention group) with random block sizes of 3,6,12,6, and 18. Unit of randomization was individuals. The computer software ( Block stratified randomization windows version 6 copyright 2010 by Steven Patntadosi) was used for randomization. Given the single-centre nature of the study, an intra-hospital web-based registry software was designed by the IT specialists of the hospital and the generated random sequence were recorded in it ,therefore allocation concealment (random sequence concealment) was carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences Office of Vice-Chancellor for Global Strategies and International Affairs, Number 21, Dameshgh St., Vali-e Asr Ave., Tehran 1416753955 Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2019-12-21, 1398/09/30
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.514
Health conditions studied
1
Description of health condition studied
Evaluating inflammatory markers in patients with unstable ischemic heart diseases after cardiac rehabilitation
ICD-10 code
I20.0
ICD-10 code description
Unstable angina
Primary outcomes
1
Description
High sensitivity CRP
Timepoint
The mentioned factor were taken at Baseline mode (ie before the discharge of patients admitted for PCI). After this time, patients in the intervention group received 12 week cardiac rehabilitation and the control group received only routine care. At the end of 12 weeks, blood samples were taken again from both groups of patients.
Method of measurement
hs-CRP : hs-CRP kit by ROCHE company
2
Description
Platelet to lymphocyte ratio
Timepoint
The mentioned factor were taken at Baseline mode (ie before the discharge of patients admitted for PCI). After this time, patients in the intervention group received 12 week cardiac rehabilitations and the control group received only routine care. At the end of 12 weeks, blood samples were taken again from both groups of patients.
Method of measurement
PLR : platelet count( per cubic millimeter of blood) divided by lymphocyte count ( per cubic millimeter of blood) . Cell count was performed using SYSMEX cell counter
3
Description
Neutrophil to lymphocyte ratio
Timepoint
The mentioned factor were taken at Baseline mode (ie before the discharge of patients admitted for PCI). After this time, patients in the intervention group received 12 week cardiac rehabilitations and the control group received only routine care. At the end of 12 weeks, blood samples were taken again from both groups of patients.
Method of measurement
NLR : neutrophil count( per cubic millimeter of blood) divided by lymphocyte count ( per cubic millimeter of blood) - Cell count was performed using SYSMEX cell counter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: , Patients in the intervention group underwent a 12-week cardiac rehabilitation. The cardiac rehabilitation program included once-a-week supervised aerobic exercise session and once-a-week educational sessions for 12 weeks which started immediately after discharge. In the former, patients warmed up for 10 minutes, did isometric movements for 30 minutes, and then coolled down for 10 minutes. Patients' exercise intensity gradually increased from 50 to 80% of the heart rate reserve. In the latter, patients were educated about various lifestyle modifications: routine checking of vital signs, losing extra weight, quitting smoking, consuming appropriate fresh fruit, vegetables, fibers, and cereals, reducing alcohol, salt, and fat intake, and avoiding extreme heat and cold preventing heavy activities. In addition, patients learnent how to identify and tackle everyday sources of stress. They also received the routine care after PCI including including dual platelet inhibition, acetylsalicylic acid (Pars Darou company), and clopidogrel (Abidi company) in addition to statins (Sobhan Darou company), in accordance with current guidelines
Category
Rehabilitation
2
Description
Control group: Patients in this group only received the routine care after PCI including dual platelet inhibition, acetylsalicylic acid, and clopidogrel in addition to statins, in accordance with current guidelines
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center hospital
Full name of responsible person
Zahra Rahnemoon
Street address
North Kargar-Ave , Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9731
Email
thc@tums.ac.ir
Web page address
http://thc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences Office of Vice-Chancellor for Global Strategies and International Affairs, Number 21, Dameshgh St., Vali-e Asr Ave
City
Tehran
Province
Tehran
Postal code
14155-6559
Phone
+98 21 8889 6692
Fax
+98 21 8889 6696
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mana Jameie
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran heart center, North-Kargar Ave
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
009888029600
Email
jameie.mana@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pejman Mansouri
Position
Cardiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart center, North-Kargar ave
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
09982188029600
Email
dr.pmansouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mana Jameie
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North-Kargar avenue
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
jameie.mana@gmail.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