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Effects of "Enhanced External Counterpulsation Combined with Cardiac Rehabilitation" and "only Cardiac Rehabilitation" on Clinical Parameters and plasma Nitic oxide, Endoteline and High sensitive CRP in the Patients with Coronar artery Diseases

Protocol summary

Summary
The aim of this study is to compare the effects of "cardiac rehabilitation" and "cardiac rehabilitation combined with EECP" on patients with ischemic heart disease according to the biochemical parameters (plasma levels of nitric oxide, endothelin-1 and High sensitive CRP) as a primary outcome and clinical parameters (Canadian Cardiovascular Society Angina scale, quality of life questionnaire SF36) as secondary outcomes. A total of 40 cases of ischemic heart disease, which is documented by angiography, perfusion scan, ECG or exercise stress test, with at least ejection fraction of 30% and age more than 30 years old will be enrolled. The patients are randomly assigned into 2 groups: Group A receive only 20-session cardiac rehabilitation, based on CR-2 protocol includes a 10 minutes warm up, 20 minutes walking on treadmill, cycling on stationary bike, and finally 5 minutes of relaxation and cool down take place. Group B receive with cardiac rehabilitation combined with 35 sessions of EECP that each session lasting one hour. Before treatment and at the end of the study, HSCRP, ET1, and NO are checked. And in the group B, prior to receiving EECP, HSCRP, ET1, and NO are rechecked. CCS Angina Scale and the quality of life questionnaire SF36 will be completed by the patients at the beginning and at end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111024422N3
Registration date: 2011-11-21, 1390/08/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-11-21, 1390/08/30
Registrant information
Name
Seyed Kazem Shakouri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3518
Email address
shakourik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor Of Research, Tabriz University of Medical Science
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of "Enhanced External Counterpulsation Combined with Cardiac Rehabilitation" and "only Cardiac Rehabilitation" on Clinical Parameters and plasma Nitic oxide, Endoteline and High sensitive CRP in the Patients with Coronar artery Diseases
Public title
Comparison of the effects of "EECP Combined with Cardiac Rehabilitation" and "only Cardiac Rehabilitation" on the treatment of ischemic heart disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients after myocardial infarction, age over 30 years old, ischemic heart disease which is documented by at least one of the followings: angiography, Perfusion scan, ECG, exercise Test, EF≥30 Exclusion criteria: Arrhythmias that will lead to impaired performance, susceptibility to bleeding, Active thrombophlebitis, proven aortic aneurysms that require to surgery, pregnancy, patients with significant valvular heart disease (Severe AI-severe AS - severe MS), using of nitrocantine
Age
From 30 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor for research, Tabriz University of Medical Sciences
Street address
Research center, No 2 central building, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2011-10-19, 1390/07/27
Ethics committee reference number
5/4/5703

Health conditions studied

1

Description of health condition studied
Ischemic heart disease
ICD-10 code
I20-I25
ICD-10 code description
Ischemic heart disease

Primary outcomes

1

Description
level of blood hsCRP
Timepoint
before beginning and at the end of study for all patients,also for group B befor EECP
Method of measurement
using the kit of hsCRP(mg/lit)

2

Description
level of blood Nitric oxide
Timepoint
before beginning and at the end of study for all patients,also for group B befor EECP
Method of measurement
using the kit of Nitric oxide (umol/lit)

3

Description
level of blood Endotelin-1
Timepoint
before beginning and at the end of study for all patients ,also for group B before EECP
Method of measurement
using the kit of Endotelin-1( pg/lit)

Secondary outcomes

1

Description
clinical parameters
Timepoint
before beginning and at the end of study for all patients
Method of measurement
quality of life questionnaire sf36, Canadian Cardiovascular Society Angina scale

Intervention groups

1

Description
Group A: only 20-sessions cardiac rehabilitation, based on CR-2 protocol includes a 10 minutes warm up, 20 minutes walking on treadmill ,cycling on stationary bike, and finally 5 minutes of relaxation and cool down
Category
Rehabilitation

2

Description
Group B: cardiac rehabilitation combined with 35 sessions of EECP that each session lasting one hour
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Shaheed Madani hospital
Full name of responsible person
Dr seyed kazem shakouri
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice-chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Research center, No 2 central building, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice-chancellor for Research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Seyyed Kazem Shakouri
Position
Physical medicine and rehabilitation professional, MD
Other areas of specialty/work
Street address
Shaheed Madani hospital, Daneshgah street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 4672
Fax
+98 41 1336 4659
Email
shakourik@tbzmed.ac.ir,zrazavia@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Physical medicine and rehabilitation ward of Emam Reza hospital
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Position
Physical medicine and rehabilitation proffesional, MD
Other areas of specialty/work
Street address
Physical medicine and rehabilitation ward, Tabriz university of medical sciences
City
Tabriz
Postal code
Phone
+98 41 1337 3954
Fax
Email
shakourik@tbzmed.ac.ir ,zrazavia@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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