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Prevalence Of Internal Pudendal Artery Disease In Patients With Erectile Dysfunction Undergoing Diagnostic Coronary Angiography

This study is currently recruiting participants.
Verified June 2012 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Atman Shah, University of Chicago
ClinicalTrials.gov Identifier:
NCT01276145
First received: January 10, 2011
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

Subjects in this study have recently had or are scheduled for a coronary angiography as part of their normal, routine medical care. This procedure uses x-ray imaging to see the inside of the heart's blood vessels.

This research study will evaluate the possible relationship between erectile dysfunction and vascular disease (diseases of the veins). In order to look at this possible relationship, subjects will complete a questionnaire which will ask questions regarding their sexual activity. Additionally, we will gather information from their medical records and take extra images during the coronary angiography procedure.


Condition
To Assess the Presence of Internal Pudendal Artery Disease in Patients With Erectile Dysfunction Undergoing Coronary Angiography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence Of Internal Pudendal Artery Disease In Patients With Erectile Dysfunction Undergoing Diagnostic Coronary Angiography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • To assess the presence of internal pudendal artery disease in patients with erectile dysfunction undergoing coronary angiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Only stable patients scheduled to undergo clinically indicated coronary angiography under non-emergent conditions will be approached for participation in the study.

Criteria

Inclusion Criteria:

  1. Male
  2. Age >40 years

Exclusion Criteria:

  1. Creatinine Clearance < 60mL/min/1.73m2
  2. Age>85
  3. History of penile prosthesis
  4. History or pelvic radiation or trauma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276145

Contacts
Contact: Melanie Norstrom (773) 702-0347 mnorstrom@medicine.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Melanie Norstrom     773-702-0347     mnorstrom@medicine.bsd.uchicago.edu    
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Atman Shah, MD University of Chicago
  More Information

No publications provided

Responsible Party: Atman Shah, Asst Prof of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01276145     History of Changes
Other Study ID Numbers: 10-292-A
Study First Received: January 10, 2011
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
pudendal artery disease
erectile dysfunction
coronary angiography
coronary disease
cardiac

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
 Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013