Condition category
Circulatory System
Date applied
05/06/2012
Date assigned
18/06/2012
Last edited
29/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Roy Debajyoti

ORCID ID

Contact details

2 Simei Street 3
Singapore
529889
Singapore

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

Sponsor information

Organisation

Changi General Hospital (Singapore)

Sponsor details

2 Simei Street 3
Singapore
529889
Singapore

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes