Evaluation of pulmonary artery pressure in response to activity in patients with non severe mitral valve stenosis after commissurotomy and its relationship with some echocardiographic variables
Evaluation of pulmonary artery systolic pressure and other echocardiogarphic variables at rest
Evaluation of pulmonary artery systolic pressure and other echocardiogarphic variables after exercise stress test
Design
Non randomised Clinical trail with single group of 200 patiens starts on April 2018 and is followed for 6 months.
Settings and conduct
Patiens reffered to Madani heart center clinic with inclusion criteria undergo echocardiography with messurment of varables then undergo stress exersice test with Bruce protocole. After the test, Pulmonary artery systolic pressue is messured again with echo and data is analised
Participants/Inclusion and exclusion criteria
Patients with history of mitral valve commissurotomy and non severe stenosis with normal pulmonary,hepatic and renal function and satisfaction for taking part in this study
Intervention groups
Patients go under 6 minute stress exercise test with Bruce protocole after first echocardiography and after the test, pulmonary artery systolic pressure is messured again with echocardiography
Main outcome variables
Pumonary artery systolic pressue increase above 60 mmHg after execise is indication of intervention with commissurotomy for mitral stenosis of these patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211001052645N1
Registration date:2022-01-23, 1400/11/03
Registration timing:retrospective
Last update:2022-01-23, 1400/11/03
Update count:0
Registration date
2022-01-23, 1400/11/03
Registrant information
Name
Naser Aslanabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7767
Email address
aslanabadin@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
2018-04-19, 1397/01/30
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2019-02-19, 1397/11/30
Scientific title
Evaluation of pulmonary artery pressure in response to activity in patients with non severe mitral valve stenosis after commissurotomy and its relationship with some echocardiographic variables
Public title
Evaluation of pulmonary artery pressure in response to activity in patients with non severe mitral valve stenosis after commissurotomy and its relationship with some echocardiographic variables
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with history of mitral valve commissurotomy and non severe mitral stenosis
Normal pulmonary,hepatic and renal function
patients satisfaction to take part in study
Exclusion criteria:
Pulmonary artery systolic pressure above 60 mmHg at rest
Disability for exercise test
Restrictive diseases like coronary artery disease,lung disease,...
Severe Mitral valve stenosis or regurgitation
Patients discontent for sudy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of Medical sciense
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-09-17, 1397/06/26
Ethics committee reference number
IR.TBZMED.REC.1397.513
Health conditions studied
1
Description of health condition studied
Patients with non severe or progressive mitral valve stenosis and history of commissurotomy
ICD-10 code
I05.0
ICD-10 code description
Rheumatic mitral stenosis
2
Description of health condition studied
Increased pulmonary artery systolic pressure after exercise
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pulmonary artery systolic pressure above 60mmHg after exercise
Timepoint
Messurement of Pulmonary artery systolic pressure before exercise test and immediately after that
Method of measurement
Echocardiogarphy machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with history of mitral valve commissurotomy and non severe mitral valve stenosis admitted to clinic
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Manai Heart center
Full name of responsible person
Nase Aslanabadi
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
1557351666
Phone
+98 41 3335 7767
Fax
+98 51 6363 9889
Email
Madanihearthosp@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamad Hiva
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
aslanabadin@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Naser Aslanabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
1557351666
Phone
+98 41 3335 7767
Email
aslanabadin@tbzmed.ac.ir
Web page address
http://www.Madanihearthosp.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naser Aslanabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
1557351666
Phone
+98 41 3335 7767
Email
aslanabadin@tbzmed.ac.ir
Web page address
http://www.madanihearthosp.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Naser Aslanabadi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
1557351666
Phone
+98 41 3335 7767
Email
aslanabadin@tbzmed.ac.ir
Web page address
http://www.mananihearthosp.tbzmed.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
all the data could be published
When the data will become available and for how long
Data would be available 6 months after edition
To whom data/document is available
The researchers and industrial occupiers could access the data
Under which criteria data/document could be used
Data of this study could be used with saving the privacy of patients
From where data/document is obtainable
Call:09141013328_09143110844
What processes are involved for a request to access data/document
The Researchers could reach the data after 1 moth evaluation