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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00885768
Other study ID # RAS001
Secondary ID
Status Completed
Phase Phase 3
First received July 11, 2008
Last updated May 11, 2011
Start date July 2008
Est. completion date April 2009

Study information

Verified date April 2009
Source Imam Khomeini Hospital
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date April 2009
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- age more than 18 years

Exclusion Criteria:

- contraindication to contrast use

- not signing consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Procedure:
angiography
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.

Locations

Country Name City State
Iran, Islamic Republic of Tehran Heart Center Tehran

Sponsors (2)

Lead Sponsor Collaborator
Imam Khomeini Hospital Tehran Heart Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of Renal Artery Stenosis (RAS) 2 months Yes
Primary The Number of Patients With Renal Artery Stenosis the prevalence of renal artery stenosis in patients with coronary artery disease 3months Yes
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