Renal Artery StenosisRASNCT00885768
Prevalence of Renal Artery Stenosis in Patients Referred for Cardiac Catheterization
An observational study of Renal Artery Stenosis, run by Imam Khomeini Hospital at 1 site in Iran.
Trial summary
All patients referred for coronary angiography will simultaneously be evaluated for renal artery stenosis and then stenosis more than 50% will be analyzed according to clinical conditions, risk factors and lab data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Artery Stenosis
- What is being tested?
- angiography
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteIran
- Study dates
- Jul 2008to Apr 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients reffered to the Tehran Heart center for coronary angiography
Who may be able to join
- age more than 18 years
Who cannot join
- contraindication to contrast use
- not signing consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Renal Artery Stenosis in Patients Refered for Cardiac Catheterization to Heart Center Hospital in July-September 2008
All patients referred for coronary angiography will simultaneously be evaluated for renal artery stenosis and then stenosis more than 50% will be analyzed according to clinical conditions, risk factors and lab data.
Read the detailed description
Renal Artery Stenosis (RAS) is a common finding in patients with generalized atherosclerosis. It is the cause of 15-20% of end stage renal disease in elderly patients. The prevalence of asymptomatic RAS in general population is unknown but it estimated to be 18% in 7th decade and more than 50% in the 8th. It is critical to find and manage the RAS before it's symptoms appear. The Gold standard for diagnosis of atherosclerotic arterial stenosis is angiography. In this study we will evaluate the prevalence, severity, location and related factors to renal artery stenosis in patients whom referred for coronary angiography in period of July-September in one of the most referral heart center in Iran, "The Tehran heart center" which is doing more than 50 coronary angiography daily.
- Conditions
- Renal Artery Stenosis
- Being tested
- angiography
- Keywords
- RAS(renal Artery Stenosis), Atherosclerosis, angiography
- Medical subject headings
- Renal Artery Obstruction, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angiographyProcedure or surgery
all patients undergoing coronary angiography with VISIPAQUE and if they had coronary stenosis then renal artery angiography will be done. the dose of contrast will be chosen according to renal function and clinical conditions which will be varied from 75 to 300 ml.
| Study group | Role | What they receive |
|---|---|---|
| A | patients with renal artery stenosis Receives: Procedure: angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Renal Artery Stenosis (RAS)
Measured: 2 months
The Number of Patients With Renal Artery Stenosis
the prevalence of renal artery stenosis in patients with coronary artery disease
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Khomeini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885768
- Sponsor's protocol ID
- RAS001
- Acronym
- RAS
- Status last verified
- Apr 2009
- First submitted
- 11 Jul 2008
- Last updated
- 13 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Renal Artery Stenosis in Patients Refered for Cardiac Catheterization to Heart Center Hospital in July-September 2008
- ClinicalTrials.gov ID
- NCT00885768
- Acronym / sponsor ID
- RAS / RAS001
- Conditions
- Renal Artery Stenosis
- Keywords
- RAS(renal Artery Stenosis), Atherosclerosis, angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Imam Khomeini HospitalUniversity, hospital or other
- Collaborators
- Tehran Heart Center
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 23 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All patients referred for coronary angiography will simultaneously be evaluated for renal artery stenosis and then stenosis more than 50% will be analyzed according to clinical conditions, risk factors and lab data.
Detailed description
Renal Artery Stenosis (RAS) is a common finding in patients with generalized atherosclerosis. It is the cause of 15-20% of end stage renal disease in elderly patients. The prevalence of asymptomatic RAS in general population is unknown but it estimated to be 18% in 7th decade and more than 50% in the 8th. It is critical to find and manage the RAS before it's symptoms appear. The Gold standard for diagnosis of atherosclerotic arterial stenosis is angiography. In this study we will evaluate the prevalence, severity, location and related factors to renal artery stenosis in patients whom referred for coronary angiography in period of July-September in one of the most referral heart center in Iran, "The Tehran heart center" which is doing more than 50 coronary angiography daily.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: angiographypatients with renal artery stenosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients reffered to the Tehran Heart center for coronary angiography
Key inclusion criteria (1 listed)
- age more than 18 years
Key exclusion criteria (2 listed)
- contraindication to contrast use
- not signing consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| angiographyall patients undergoing coronary angiography with VISIPAQUE and if they had coronary stenosis then renal artery angiography will be done. the dose of contrast will be chosen according to renal function and clinical conditions which will be varied from 75 to 300 ml. | Procedure or surgery | A |
Primary outcome
Prevalence of Renal Artery Stenosis (RAS)
Time frame: 2 months
The Number of Patients With Renal Artery Stenosis
Time frame: 3months
the prevalence of renal artery stenosis in patients with coronary artery disease
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Artery Stenosis, run by Imam Khomeini Hospital at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Renal Artery Stenosis (RAS) (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2011.