Erectile Dysfunction After Percutaneous Coronary Intervention Versus the Thrombolytic Therapy in Acute ST Elevation Myocardial Infarction

NCT03328156 | Unknown

• 1 other identifier: 17100377
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Erectile dysfunction is a common sexual problem affecting up to one-third of men throughout their life. It is now well recognized that risk factors for erectile dysfunction (ED) include the same risk factors as coronary artery disease, including smoking, dyslipidemia, diabetes, hypertension, lack of physical activity and obesity. We will investigate the effect of reperfusion strategies (primary angioplasty \& therapeutic therapy) on the prevalence of erectile dysfunction after acute myocardial infarction. Erectile function will be evaluated using the international index of erectile function after 3 months of successful reperfusion treatment of acute myocardial infarction.

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

• The International Index of Erectile Function (IIEF-5) Questionnaire

  the cases will be classified as: * without ED (score greater than 25 points) * mild ED (score 17 to 25), * moderate ED (score 11 to 16) * severe ED (score 10 points or less). No treatment for ED would applied within the 3-month period prior to the second IIEF evaluation for each patient

  3 months

Study Arms (2)

patient with STEMI will treated by PPCI

Primary angioplasty procedure The procedure will be performed using a standard angioplasty technique. A bolus of100 IU kg of heparin will be administered intra-arterially after insertion of the vascular catheter. The target lesions will initially treated with appropriate balloon predilatation as necessary, followed by intracoronary stenting. After stent implantation, heparin will be routinely administered. The sheaths will be removed the same day.

patient with STEMI will treated by Thrombolytic therapy

oral clopidogrel (300 mg), Low-flow nasal oxygen, oral acetylsalicylic acid (325 mg), Will be given to each patient. Streptokinase will be given intravenously at 1.5 million units over approximately 60 min. Reperfusion afterTT will be assessed according to clinical criteria .

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In this study; we aim to investigate the effects of two different reperfusion strategies (primary angioplasty \& therapeutic therapy) on the prevalence of erectile dysfunction after acute myocardial infarction.

You may qualify if:

• patients with ST elevation myocardial infarction undergo to of successful reperfusion treatment

You may not qualify if:

• \- patients with an atrial fibrillation or flutter.
• patients who cannot be reperfused with thrombolytic therapy and require emergency percutaneous coronary intervention (causing crossover between the groups).
• congenital disease
• pericardial disease
• patients with renal failure
• severe valvular heart disease
• liver cirrhosis
• thyroid disease
• previous pelvic, penile, urethral or prostate surgery

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (11)

• Lewis RW. A critical look at descriptive epidemiology of sexual dysfunction in Asia compared to the rest of the world - a call for evidence-based data. Transl Androl Urol. 2013 Mar;2(1):54-60. doi: 10.3978/j.issn.2223-4683.2013.01.03.

  PMID: 26816724 BACKGROUND

• Hellstrom WJ. Does erectile dysfunction drug use contribute to risky sexual behavior? Asian J Androl. 2010 Sep;12(5):626-7. doi: 10.1038/aja.2010.98. No abstract available.

  PMID: 20818401 BACKGROUND

• Montorsi P, Montorsi F, Schulman CC. Is erectile dysfunction the "tip of the iceberg" of a systemic vascular disorder? Eur Urol. 2003 Sep;44(3):352-4. doi: 10.1016/s0302-2838(03)00307-5. No abstract available.

  PMID: 12932935 BACKGROUND

• O'Kane PD, Jackson G. Erectile dysfunction: is there silent obstructive coronary artery disease? Int J Clin Pract. 2001 Apr;55(3):219-20.

  PMID: 11351777 BACKGROUND

• Borgquist R, Gudmundsson P, Winter R, Nilsson P, Willenheimer R. Erectile dysfunction in healthy subjects predicts reduced coronary flow velocity reserve. Int J Cardiol. 2006 Sep 20;112(2):166-70. doi: 10.1016/j.ijcard.2005.08.035. Epub 2005 Nov 4.

  PMID: 16271777 BACKGROUND

• Ho CC, Singam P, Hong GE, Zainuddin ZM. Male sexual dysfunction in Asia. Asian J Androl. 2011 Jul;13(4):537-42. doi: 10.1038/aja.2010.135. Epub 2011 Jun 6.

  PMID: 21643001 BACKGROUND

• Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction; Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernandez-Aviles F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. doi: 10.1161/CIRCULATIONAHA.107.187397. Epub 2007 Oct 19. No abstract available.

  PMID: 17951284 BACKGROUND

• Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.

  PMID: 12517460 BACKGROUND

• Greenstein A, Chen J, Miller H, Matzkin H, Villa Y, Braf Z. Does severity of ischemic coronary disease correlate with erectile function? Int J Impot Res. 1997 Sep;9(3):123-6. doi: 10.1038/sj.ijir.3900282.

  PMID: 9315488 BACKGROUND

• Chughtai B, Lee RK, Te AE, Kaplan SA. Metabolic syndrome and sexual dysfunction. Curr Opin Urol. 2011 Nov;21(6):514-8. doi: 10.1097/MOU.0b013e32834b8681.

  PMID: 21897258 BACKGROUND

• Jackson G, Solomon H, Wierzbicki AS. Letter regarding article by Gazzaruso et al, "Relationship between erectile dysfunction and silent myocardial ischemia in apparently uncomplicated, type 2 diabetic patients". Circulation. 2005 Jan 18;111(2):e18-9; author reply e18-9. doi: 10.1161/01.CIR.0000152482.71628.51. No abstract available.

  PMID: 15657383 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Yehia Taha Keshk, MD

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Resident

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 1, 2017
• Study Start: October 30, 2017
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

EG (1)