Predicting Peripheral Arterial Disease in Men With Erectile Dysfunction

NCT00743613 | Completed

• 1 other identifier: PREPARED 001
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 5

Brief Summary

Erectile dysfunction is a common complaint and is found frequently in men with hyperlipidemia, hypertension, diabetes and those who smoke. ED may also be an early warning of peripheral arterial disease. This study is designed to look for a relationship between the degree of ED and the presence of PAD when associated with co-morbid conditions.

Conditions

Erectile Dysfunction; Peripheral Arterial Disease

Keywords

Erectile Dysfunction; ED; Peripheral Arterial Disease; PAD; Ankle-Brachial Index; ABI

Outcome Measures

Primary Outcomes (1)

• Sexual Health Inventory for Men (SHIM)

  initial visit

Secondary Outcomes (1)

• Ankle-Brachial Index (ABI)

  Initial Visit

Interventions

Sexual Health Inventory for Men (SHIM) BEHAVIORAL

Five question test with maximum score of 25 points administered on the initial visit. Erectile dysfunction is indirectly related to the score.

Also known as: SHIM, Sexual Health Inventory for Men

Ankle-Brachial Index (ABI) PROCEDURE

Measure Ankle-Brachial Index with a hand held doppler and sphygmomanometer to determine the ABI.

Also known as: Multi Dopplex II 8-mHz

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men 50 years old or older with either diabetes, hypertension, hyperlipidemia and/or a history of tobacco use.

You may qualify if:

• Men 50 years old or older
• Must have a history of diabetes, hypertension, hyperlipidemia and/or a history of tobacco use

You may not qualify if:

• Men younger than 50 years of age
• No co-morbid condition such as diabetes, hypertension, hyperlipidemia and/or tobacco use.

Sponsors & Collaborators

• Bruton Avenue Family Practice: lead
• Pfizer: collaborator

Study Sites (5)

UMass, Fitchburg Family Medicine Center

Fitchburg, Massachusetts, 01420, United States

Location

Mercury West Family Practice

Hampton, Virginia, 23666, United States

Location

Bruton Avenue Family Practice

Newport News, Virginia, 23601, United States

Location

Hilton Family Practice

Newport News, Virginia, 23601, United States

Location

Williamsburg Medical Arts-Family Medicine

Williamsburg, Virginia, 23185, United States

Location

Related Publications (17)

• Grover SA, Lowensteyn I, Kaouache M, Marchand S, Coupal L, DeCarolis E, Zoccoli J, Defoy I. The prevalence of erectile dysfunction in the primary care setting: importance of risk factors for diabetes and vascular disease. Arch Intern Med. 2006 Jan 23;166(2):213-9. doi: 10.1001/archinte.166.2.213.

  PMID: 16432091 RESULT

• Gazzaruso C, Giordanetti S, De Amici E, Bertone G, Falcone C, Geroldi D, Fratino P, Solerte SB, Garzaniti A. Relationship between erectile dysfunction and silent myocardial ischemia in apparently uncomplicated type 2 diabetic patients. Circulation. 2004 Jul 6;110(1):22-6. doi: 10.1161/01.CIR.0000133278.81226.C9. Epub 2004 Jun 21.

  PMID: 15210604 RESULT

• Lue TF. Erectile dysfunction. N Engl J Med. 2000 Jun 15;342(24):1802-13. doi: 10.1056/NEJM200006153422407. No abstract available.

  PMID: 10853004 RESULT

• Solomon H, Man JW, Jackson G. Erectile dysfunction and the cardiovascular patient: endothelial dysfunction is the common denominator. Heart. 2003 Mar;89(3):251-3. doi: 10.1136/heart.89.3.251.

  PMID: 12591819 RESULT

• Jackson G. Endothelial function and dysfunction. Int J Clin Pract. 2004 May;58(5):431. doi: 10.1111/j.1368-5031.2004.00255.x. No abstract available.

  PMID: 15206495 RESULT

• Deedwania PC. Endothelium: a new target for cardiovascular therapeutics. J Am Coll Cardiol. 2000 Jan;35(1):67-70. doi: 10.1016/s0735-1097(99)00536-7. No abstract available.

  PMID: 10636261 RESULT

• Hurairah H, Ferro A. The role of the endothelium in the control of vascular function. Int J Clin Pract. 2004 Feb;58(2):173-83. doi: 10.1111/j.1368-5031.2004.0103.x. No abstract available.

  PMID: 15055866 RESULT

• Kloner RA. Erectile dysfunction in the cardiac patient. Curr Urol Rep. 2003 Dec;4(6):466-71. doi: 10.1007/s11934-003-0028-9.

  PMID: 14622500 RESULT

• Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.

  PMID: 9187685 RESULT

• Cappelleri JC, Rosen RC. The Sexual Health Inventory for Men (SHIM): a 5-year review of research and clinical experience. Int J Impot Res. 2005 Jul-Aug;17(4):307-19. doi: 10.1038/sj.ijir.3901327.

  PMID: 15875061 RESULT

• Sutton-Tyrrell K, Rihal C, Sellers MA, Burek K, Trudel J, Roubin G, Brooks MM, Grogan M, Sopko G, Keller N, Jandova R. Long-term prognostic value of clinically evident noncoronary vascular disease in patients undergoing coronary revascularization in the Bypass Angioplasty Revascularization Investigation (BARI). Am J Cardiol. 1998 Feb 15;81(4):375-81. doi: 10.1016/s0002-9149(97)00934-x.

  PMID: 9485122 RESULT

• Carman TL, Fernandez BB Jr. A primary care approach to the patient with claudication. Am Fam Physician. 2000 Feb 15;61(4):1027-32, 1034.

  PMID: 10706155 RESULT

• Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.

  PMID: 11560536 RESULT

• Champion H. Erectile Dysfunction and Cardiovascular Disease: Carrots, Sticks, and Better Men's Health. Adv Stud Med. 6(4):163-170, 2006

  RESULT

• Vinick A, Richardson D. Erectile Dysfunction in Diabetes. Diabetic Reviews 6:16-33, 1998.

  RESULT

• Fedele D, Bortolotti A, Coscelli C, Santeusanio F, Chatenoud L, Colli E, Lavezzari M, Landoni M, Parazzini F. Erectile dysfunction in type 1 and type 2 diabetics in Italy. On behalf of Gruppo Italiano Studio Deficit Erettile nei Diabetici. Int J Epidemiol. 2000 Jun;29(3):524-31.

  PMID: 10869326 RESULT

• Brunton S: Raising the Profile of Peripheral Arterial Disease. AANP 18th Annual National Conference, July 1, 2003, Anaheim, CA.

  RESULT

MeSH Terms

Conditions

Erectile Dysfunction; Peripheral Arterial Disease

Interventions

Menogaril

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Nogalamycin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• James T Edwards, Jr, MS, MD

  Bruton Avenue Family Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: February 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: May 1, 2008
• Last Updated: September 3, 2008

Record last verified: 2008-09

Locations

US (5)