The aim of this study is to evaluate the effect of hyperemia in pressure gradients of moderate renal artery stenosis in hypertensive patients.There is no definite method for decision making about moderate renal artery stenosis.Ten hypertensive patients with moderate renal artery stenosis are evaluated.Stenosis of renal artery should be at 1/3 proximal.Patients with mild(lower than50%) or severe(more than 90%) stenosis or stenosis other than 1/3 proximal are exclude from the study.For each patient fractional flow reserve (FFR) of renal artery stenosis before and after hyperemia(by adenosine injection) are performed and if the FFR be lower than 0.85, renal stent will be implanted.After stenting,FFR perform for evaluation of stenting succeed.The results and demographic data will analyzed by statistic method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202028903N1
Registration date:2012-11-05, 1391/08/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-05, 1391/08/15
Registrant information
Name
Aref Fatehi
Name of organization / entity
Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3208 3106
Email address
fatehiaref@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice-chancellor for Research and technology
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative survey of pressure gradients in moderate renal artery stenosis before and after hyperemia in hypertensive patients
Public title
Physiologic assesment of moderate renal artery stenosis
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:Hypertensive patients; Patients with renal artery stenosis
Exclusion criteria: Patients with mild or severe renal artery stenosis; renal artery stenosis other than 1/3 proximal
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Kermanshah university of medical sciences and health services
Street address
Shahid Beheshti blvd
City
kermanshah
Postal code
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
4144
Health conditions studied
1
Description of health condition studied
renal artery stenosis
ICD-10 code
I70.1
ICD-10 code description
Atherosclerosis of renal artery
Primary outcomes
1
Description
Pressure gradient after adenosine injection
Timepoint
During renal angiography
Method of measurement
By pressure wire
2
Description
Pressure gradient before adenosine injection
Timepoint
During renal angiography
Method of measurement
By pressure wire
Secondary outcomes
1
Description
Pressure gradient after stenting
Timepoint
After stenting
Method of measurement
By pressure wire
Intervention groups
1
Description
Renal artery stenting
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam ali cardiovascular hospital
Full name of responsible person
Aref Fatehi
Street address
Training Unit, Imam ali hospital, Shahid Beheshti blvd
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah university of medical sciences and health services
Full name of responsible person
Dr. Farid Najafi
Street address
Shahid beheshti blvd, Kermanshah university of medical sciences and health services
City
Kermanshah
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, Kermanshah university of medical sciences and health services
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
Kermanshah university of medical siences
Full name of responsible person
Aref Fatehi
Position
Cardiology resident
Other areas of specialty/work
Street address
Training Unit, Imam ali hospital, Shahid Beheshti blvd
City
Kermanshah
Postal code
Phone
+98 83 1836 2022
Fax
Email
fatehiaref@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences and health services
Full name of responsible person
Alireza Rai
Position
Interventionalist
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti blvd
City
Kermanshah
Postal code
Phone
+98 83 1836 2022
Fax
Email
Alireza_rai@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Aref Fatehi
Position
Cardiology resident
Other areas of specialty/work
Street address
Training Unit, Imam ali hospital, Shahid Beheshti blvd
City
Kermanshah
Postal code
Phone
+98 83 1836 2022
Fax
+98 83 1836 2022
Email
fatehiaref@gmail.comfatehiaref@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)