ISRCTN ISRCTN99641923
DOI https://doi.org/10.1186/ISRCTN99641923
Secondary identifying numbers N/A
Submission date
05/06/2012
Registration date
18/06/2012
Last edited
29/09/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Roy Debajyoti
Scientific

2 Simei Street 3
Singapore
529889
Singapore

Study information

Study designCohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePrevalence and risk factors of renal artery stenosis in South Asian patients with type 2 diabetes using renal angiography
Study objectivesTo determine the prevalence and risk factors of renal artery stenosis (RAS) in patients with type 2 diabetes.
Ethics approval(s)Institutional Board of Inlak Budhram Hospital, Pune, India, December 2007
Health condition(s) or problem(s) studiedRenal artery stenosis in patients with type 2 diabetes
InterventionStatistical 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 typeOther
Primary outcome measurePrevalence of renal artery stenosis
Secondary outcome measuresRisk factors of renal artery stenosis
Overall study start date01/01/2008
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants249
Key inclusion criteriaAll 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.
Key exclusion criteria1. Patients with known vasculitis
2. Renal artery stenosis
3. A serum creatinine level of >3.0 mg/dl or on renal replacement therapy
Date of first enrolment01/01/2008
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • India
  • Singapore

Study participating centre

2 Simei Street 3
Singapore
529889
Singapore

Sponsor information

Changi General Hospital (Singapore)
Hospital/treatment centre

2 Simei Street 3
Singapore
529889
Singapore

ROR logo "ROR" https://ror.org/02q854y08

Funders

Funder type

Hospital/treatment centre

Inlak Budhram Hospital (India)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan