STEMINCT03328156
Erectile Dysfunction After Percutaneous Coronary Intervention Versus the Thrombolytic Therapy in Acute ST Elevation Myocardial Infarction
An observational study of STEMI, run by Assiut University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- STEMI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2017to 1 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- patients with ST elevation myocardial infarction undergo to of successful reperfusion treatment
Who cannot join
- - 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
Show all 9Show fewer
- liver cirrhosis
- thyroid disease
- previous pelvic, penile, urethral or prostate surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Myocardial infarction the term acute myocardial infarction(AMI) should be used when there is evidence of myocardial injury (defined as an elevation of cardiac troponin values with at least one value above the 99th percentile upper reference limit) with necrosis in a clinical setting consistent with myocardial ischemia . Myocardial infarction is classified as either : ST elevation acute myocardial infarction.* non-ST segment elevation acute myocardial infarction. according to the electrocardiogram at the time of admission.
There are Two main treatment modalities for STEMI which are primary percutaneous coronary intervention (PPCI) \& thrombolytic treatment (TT).
- Erectile dysfunction (ED) is defined as the recurrent or persistent inability to achieve and/or maintain an erection for satisfactory intercourse.Erectile function will be evaluated using the international index of erectile function in the hospital to characterize each patients sexual function before the acute myocardial infarction \& 3 months after the event.
International Index of Erectile Function (IIEF-5) Questionnaire
- How do you rate your confidence that could you get and keep an erection? 1)very low 2)low 3)moderate 4)high 5)very high
- . When you had erections with sexual stimulation, how often were your erections hard enough for penetration?
- Almost never/never 2) A few times (much less than half the time) 3) Sometimes (about half the time) 4) Most times (much more than half the time) 5) Almost always/always 3-During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?
- Almost never/never
- A few times (much less than half the time)
- Sometimes (about half the time)
- Most times (much more than half the time)
- Almost always/always 4- During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?
- Extremely difficult 2) Very difficult 3) Difficult 4) Slightly difficult 5) Not difficult 5- When you attempted sexual intercourse, how often was it satisfactory for you?
- ) Almost never/never
- A few times (much less than half the time)
- Sometimes (about half the time)
- Most times (much more than half the time)
- Almost always/always 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
- Conditions
- STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start30 Oct 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for STEMIStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mahmmoud Syed, Assiut University
- Investigators
- Yehia Taha Keshk, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328156
- Sponsor's protocol ID
- 17100377
- Status last verified
- Nov 2017
- First submitted
- 29 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26816724Hellstrom 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.
PubMed 20818401Montorsi 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.
PubMed 12932935O'Kane PD, Jackson G. Erectile dysfunction: is there silent obstructive coronary artery disease? Int J Clin Pract. 2001 Apr;55(3):219-20.
PubMed 11351777Borgquist 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.
PubMed 16271777Ho 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.
PubMed 21643001Thygesen 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.
PubMed 17951284Keeley 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.
PubMed 12517460Greenstein 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.
PubMed 9315488Chughtai 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.
PubMed 21897258Jackson 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.
PubMed 15657383
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Dysfunction After Percutaneous Coronary Intervention Versus the Thrombolytic Therapy in Acute ST Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03328156
- Acronym / sponsor ID
- 17100377
- Conditions
- STEMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Myocardial infarction the term acute myocardial infarction(AMI) should be used when there is evidence of myocardial injury (defined as an elevation of cardiac troponin values with at least one value above the 99th percentile upper reference limit) with necrosis in a clinical setting consistent with myocardial ischemia . Myocardial infarction is classified as either : ST elevation acute myocardial infarction.* non-ST segment elevation acute myocardial infarction. according to the electrocardiogram at the time of admission.
There are Two main treatment modalities for STEMI which are primary percutaneous coronary intervention (PPCI) \& thrombolytic treatment (TT).
- Erectile dysfunction (ED) is defined as the recurrent or persistent inability to achieve and/or maintain an erection for satisfactory intercourse.Erectile function will be evaluated using the international index of erectile function in the hospital to characterize each patients sexual function before the acute myocardial infarction \& 3 months after the event.
International Index of Erectile Function (IIEF-5) Questionnaire
- How do you rate your confidence that could you get and keep an erection? 1)very low 2)low 3)moderate 4)high 5)very high
- . When you had erections with sexual stimulation, how often were your erections hard enough for penetration?
- Almost never/never 2) A few times (much less than half the time) 3) Sometimes (about half the time) 4) Most times (much more than half the time) 5) Almost always/always 3-During sexual intercourse, how often were you able to maintain your erection after you had penetrated (entered) your partner?
- Almost never/never
- A few times (much less than half the time)
- Sometimes (about half the time)
- Most times (much more than half the time)
- Almost always/always 4- During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse?
- Extremely difficult 2) Very difficult 3) Difficult 4) Slightly difficult 5) Not difficult 5- When you attempted sexual intercourse, how often was it satisfactory for you?
- ) Almost never/never
- A few times (much less than half the time)
- Sometimes (about half the time)
- Most times (much more than half the time)
- Almost always/always 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 . |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients with ST elevation myocardial infarction undergo to of successful reperfusion treatment
Key exclusion criteria (9 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The International Index of Erectile Function (IIEF-5) Questionnaire
Time frame: 3 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 26816724Lewis 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.
- Background: PubMed 20818401Hellstrom 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.
- Background: PubMed 12932935Montorsi 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.
- Background: PubMed 11351777O'Kane PD, Jackson G. Erectile dysfunction: is there silent obstructive coronary artery disease? Int J Clin Pract. 2001 Apr;55(3):219-20.
- Background: PubMed 16271777Borgquist 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.
- Background: PubMed 21643001Ho 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.
- Background: PubMed 17951284Thygesen 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.
- Background: PubMed 12517460Keeley 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.
- Background: PubMed 9315488Greenstein 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.
- Background: PubMed 21897258Chughtai 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.
- Background: PubMed 15657383Jackson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehia Taha Keshk, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Index of Erectile Function (IIEF-5) Questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03328156, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.