Plain English Summary
Background and study aims
Renal artery stenosis (RAS) is a narrowing of the arteries that carry blood to one or both of the kidneys. It is associated with an increased risk of high blood pressure and progression of kidney disease. However, in clinical practice, the presence of renal artery stenosis may be difficult to distinguish in patients with type 2 diabetes with kidney disease. This study was designed to find out about the prevalence of previously undetected renal artery stenosis in a group of South Asian patients with type 2 diabetes undergoing angiography for investigation of heart disease, and to find clinical characteristics that may aid in the identification of these patients.
Who can participate?
Patients with type 2 diabetes who are undergoing coronary angiography.
What does the study involve?
All recruited patients will have a renal angiography carried out at the same sitting as a coronary angiography.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part.
Where is the study run from?
Inlaks & Budhram Hospital, Pune, India.
When is the study starting and how long is it expected to run for?
The study started in January 2008 and ended in December 2008.
Who is funding the study?
Inlaks & Budhram Hospital, Pune, India
Who is the main contact?
Dr Eberta Tan
Eberta_Tan@cgh.com.sg
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prevalence and risk factors of renal artery stenosis in South Asian patients with type 2 diabetes using renal angiography
Acronym
Study hypothesis
To determine the prevalence and risk factors of renal artery stenosis (RAS) in patients with type 2 diabetes.
Ethics approval
Institutional Board of Inlak Budhram Hospital, Pune, India, December 2007
Study design
Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Renal artery stenosis in patients with type 2 diabetes
Intervention
Statistical analysis
The characteristics of patients with RAS were compared to those without RAS using Student's t-tests for continuous variables and Chi-Square or Fisher tests for comparison of categorical variables as appropriate. Univariate logistic regressions were performed to identify the factors associated with the presence of RAS. From the significant variables identified at this step, the backward stepwise method was used to identify variables that were independently associated with the outcome using the likelihood ratio test. Odds ratios and their corresponding 95% confidence intervals were presented as effect size. Tests for the appropriate assumptions for the models were carried out. Data was analyzed using SAS v9.2 (SAS Institute Inc., Cary, NC, USA) and the level of significance was set at 5%.
Total duration of follow-up: 1 day
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Prevalence of renal artery stenosis
Secondary outcome measures
Risk factors of renal artery stenosis
Overall trial start date
01/01/2008
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
All consecutive patients with type 2 diabetes who underwent coronary angiography and who gave informed consent to be screened for renal artery stenosis at the same time were recruited into the study. The decision for coronary angiography was made by the consulting cardiologist based on a clinical indication of either symptomatic angina, ST-T alterations on the electrocardiogram or an acute myocardial infarction.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
249
Participant exclusion criteria
1. Patients with known vasculitis
2. Renal artery stenosis
3. A serum creatinine level of >3.0 mg/dl or on renal replacement therapy
Recruitment start date
01/01/2008
Recruitment end date
31/12/2008
Locations
Countries of recruitment
India
Trial participating centre
2 Simei Street 3
Singapore
529889
Singapore
Funders
Funder type
Hospital/treatment centre
Funder name
Inlak Budhram Hospital (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary