Erectile DisfunctionERECT-PCINCT07444697
"Erectile Function After PCI in MI and Non-MI Patients"
An observational study of Erectile Disfunction and Coronary Artery Disease (CAD), run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. Read more about this study
- Who is it for?
- Ages 30 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Disfunction, Coronary Artery Disease (CAD), Diabete Mellitus
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to Nov 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult male patients treated with percutaneous coronary intervention (PCI) for either acute myocardial infarction or stable angina at the Cardiology Department of Kırıkkale University Hospital. Eligible participants will be recruited consecutively after successful PCI and clinical stabilization. The study represents a hospital-based, observational cohort reflecting the typical male population undergoing PCI in a tertiary referral center. All assessments and follow-up visits will be conducted within the same institution's cardiology and urology outpatient clinics.
Who may be able to join
- Male patients aged 30-75 years
- Undergoing successful percutaneous coronary intervention (PCI) for one of the following:
- Acute myocardial infarction (Group 1)
- Stable angina (Group 2)
- Hemodynamically stable after the PCI procedure
- Survival of the index hospitalization
Show all 33Show fewer
- Ability to provide written informed consent
- Sexually active within the 3 months prior to enrollment
- Willingness and ability to complete follow-up visits and questionnaires at:
- Baseline (post-PCI recovery)
- 3 months
- 6 months Exclusion Criteria
- Known malignancy (active or recently treated)
- Neurological disorders affecting erectile function, including:
- Spinal cord injury
- Multiple sclerosis
- Parkinson's disease
- Uncontrolled diabetes mellitus (HbA1c > 9%)
- Presence of more than two chronic systemic diseases, such as:
- Severe renal disease
- Severe hepatic disease
- Severe pulmonary disease
- Polypharmacy, defined as chronic use of more than three daily medications
- Absence of sexual activity or lack of a sexual partner
- Refusal or inability to provide informed consent or complete study questionnaires
- Severe psychiatric illness interfering with study participation
- Endocrine disorders, including:
- Untreated hypogonadism
- Thyroid disease
- Major post-PCI complications preventing participation, including:
- Reinfarction
- Stroke
- Heart failure
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
The Hospital of Kirikkale Univerity Faculty of Medicine
Kirikkale, 71450
Timucin Sipal, MD, PhD, +905338170659, drtimucin@hotmail.com
Caglar Alp, MD, PhD, +905054013070, drcaglaralp@gmail.com
About this study
Official title: Erectile Function After Percutaneous Coronary Intervention in Myocardial Infarction and Non-Infarction Patients: A Prospective Comparative Study.
The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.
Read the detailed description
In Thıs study, we aım to evaluate the erectile status of male patients undergoing percutaneous coronary intervention after both heart attack ( group 1) and stable angina ( Group 2).
The primary aim is to assess any possible predictive effect of erectile function status on cardiac events.
The secondary aim is to assess the direct effect of myocardial infarction on ED status by comparing the two groups.
The secondary objective is to assess and analyse other determinants in the natural history survey of erectile status after the intervention.
All male patients who undergo a successful PCI and survive will be evaluated. Patients who have had: Malignancy, underlying neurological diagnosis interfering with erectile status, uncontrolled diabetes, and more than two chronic medical conditions, on polifarmacy ( more than three medications a day), and no sexual relationship, who have not agreed to include the study, will not be included in the study.
The follow-up period will be 0 (the time the patient recovered well after the intervention). Questinnaiere will examine the status over the last 3 months.
3 and 6-month follow-up. During the follow-up period, the interviews will be conducted face-to-face in the clinical environment, either by a responsible doctor or an educated nurse.
The surveys include:
IIEF (International Index of erectile function ) questionnaires BECK depression inventory questionnaires FCRP ( Fear of Cardiac Recurrence and Progression Scale )
The objective scale we use:
Age SYNTAX score and residual SYNTAX score for evaluating the cardiac vessels occlusion status Cardiac Ejection Fraction status Laboratory values, including testosterone levels, Bodily measurements, including body mass index and waist circumference. Medications Medical conditions Intervention route ( trans radial or femoral )
The survey will take place in our institutions.
The hypothesis is that erectile dysfunction is a preliminary condition of an upcoming cardiac event.
Myocardial infarction causes significant changes in erectile function in a natural survey.
The syntax score has a direct correlation with the baseline erectile function Residual syntax score has a direct relation with post-intervention erectile status.
- Conditions
- Erectile Disfunction, Coronary Artery Disease (CAD), Diabete Mellitus, Anxiety, Depression and Quality of Life
- Keywords
- erectile disfunction, coronary artery disease, Syntax score, percutaneous coronary intervention, anxiety, Fear, angina
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus, Anxiety Disorders, Depression, Angina Pectoris
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 |
|---|---|---|
| Group 1 | Patients who undergo PCI due to a heart attack | |
| Group 2 | Patients who undergo PCI due to a stabile angina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erectile function score after percutaneous coronary intervention (PCI)
Description:
Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire. The primary outcome is the change in mean IIEF-5 score from baseline to 6 months after PCI, comparing patients with myocardial infarction (Group 1) and those with stable angina (Group 2). A decrease in IIEF-5 score indicates worsening erectile function.
Measured: Baseline (post-recovery from PCI) to 6 months follow-up]
Secondary outcomes (3)
Effect of myocardial infarction on post-PCI erectile function
Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire, and changes in IIEF-5 scores will be compared between patients with myocardial infarction and those with stable angina following percutaneous coronary intervention (PCI).
Measured: Baseline (post-PCI recovery) and 6 months after PCI
Effect of myocardial infarction on post-PCI erectile function
Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire, and changes in IIEF-5 scores from baseline to 6 months after PCI will be compared between patients with myocardial infarction and those with stable angina.
Measured: Baseline (post-PCI recovery) and 6 months after PCI
Association between fear symptoms and post-PCI erectile function Fear symptoms will be assessed using the Beck Depression Inventory (BDI), and their association with erectile function measured by the IIEF-5 will be examined.
Fear symptoms will be assessed using the Fear of Cardiac Recurrence and Progression Scale (FCRP) scores, and their association with erectile function, as measured by the IIEF-5, will be examined.
Measured: Baseline, 3 months, and 6 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 Jan 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Erectile DisfunctionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timucin Sipal, Kırıkkale University
- Investigators
- Timucin Sipal, Assistan Prof, Principal investigator, Kirikkale Univerity faculty of medicine department of UrologyCaglar Alp, Assistant Prof, Study director, Kirikkale Univerity Faculty of Medicine department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444697
- Sponsor's protocol ID
- 2025.10.39
- Acronym
- ERECT-PCI
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy considerations.
Publications
Dostalova G, Hlubocka Z, Bayerova K, Belohlavek J, Linhart A, Karetova D. Erectile Dysfunction in Young Myocardial Infarction Survivors: Evaluation, Follow Up. Am J Mens Health. 2017 Nov;11(6):1739-1744. doi: 10.1177/1557988317714359. Epub 2017 Jul 11.
PubMed 28697641Hodzic E, Durek A, Begic E, Sabanovic Bajramovic N. Effect of myocardial infarction on the occurrence of erectile dysfunction. Med Glas (Zenica). 2019 Feb 1;16(1):35-39. doi: 10.17392/981-19.
PubMed 30589239Adam A, McDowall J, Aigbodion SJ, Enyuma C, Buchanan S, Vachiat A, Sheahan J, Laher AE. Is the History of Erectile Dysfunction a Reliable Risk Factor for New Onset Acute Myocardial Infarction? A Systematic Review and Meta-Analysis. Curr Urol. 2020 Oct;14(3):122-129. doi: 10.1159/000499249. Epub 2020 Oct 13.
PubMed 33224004Clarke ST, Le Grande M, Murphy BM, Hester R, Jackson AC. Protocol for the development and validation of a clinical measurement tool for fear of disease progression and recurrence in cardiac patients. Chronic Dis Transl Med. 2024 Jan 24;10(3):195-204. doi: 10.1002/cdt3.115. eCollection 2024 Sep.
PubMed 39027197Vacanti L, Caramelli B. Distress: associated variables of erectile dysfunction post-acute myocardial infarction. A pilot study. Int J Impot Res. 2005 Mar-Apr;17(2):204-6. doi: 10.1038/sj.ijir.3901274.
PubMed 15538397Montorsi P, Ravagnani PM, Galli S, Salonia A, Briganti A, Werba JP, Montorsi F. Association between erectile dysfunction and coronary artery disease: Matching the right target with the right test in the right patient. Eur Urol. 2006 Oct;50(4):721-31. doi: 10.1016/j.eururo.2006.07.015. Epub 2006 Jul 28.
PubMed 16901623Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE; COURAGE Trial Research Group; Mancini GB. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008 Aug 14;359(7):677-87. doi: 10.1056/NEJMoa072771.
PubMed 18703470
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Function After Percutaneous Coronary Intervention in Myocardial Infarction and Non-Infarction Patients: A Prospective Comparative Study.
- ClinicalTrials.gov ID
- NCT07444697
- Acronym / sponsor ID
- ERECT-PCI / 2025.10.39
- Conditions
- Erectile Disfunction, Coronary Artery Disease (CAD), Diabete Mellitus, Anxiety, Depression and Quality of Life
- Keywords
- erectile disfunction, coronary artery disease, Syntax score, percutaneous coronary intervention, anxiety, Fear, angina
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 3 Mar 2026 (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.
The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.
Detailed description
In Thıs study, we aım to evaluate the erectile status of male patients undergoing percutaneous coronary intervention after both heart attack ( group 1) and stable angina ( Group 2).
The primary aim is to assess any possible predictive effect of erectile function status on cardiac events.
The secondary aim is to assess the direct effect of myocardial infarction on ED status by comparing the two groups.
The secondary objective is to assess and analyse other determinants in the natural history survey of erectile status after the intervention.
All male patients who undergo a successful PCI and survive will be evaluated. Patients who have had: Malignancy, underlying neurological diagnosis interfering with erectile status, uncontrolled diabetes, and more than two chronic medical conditions, on polifarmacy ( more than three medications a day), and no sexual relationship, who have not agreed to include the study, will not be included in the study.
The follow-up period will be 0 (the time the patient recovered well after the intervention). Questinnaiere will examine the status over the last 3 months.
3 and 6-month follow-up. During the follow-up period, the interviews will be conducted face-to-face in the clinical environment, either by a responsible doctor or an educated nurse.
The surveys include:
IIEF (International Index of erectile function ) questionnaires BECK depression inventory questionnaires FCRP ( Fear of Cardiac Recurrence and Progression Scale )
The objective scale we use:
Age SYNTAX score and residual SYNTAX score for evaluating the cardiac vessels occlusion status Cardiac Ejection Fraction status Laboratory values, including testosterone levels, Bodily measurements, including body mass index and waist circumference. Medications Medical conditions Intervention route ( trans radial or femoral )
The survey will take place in our institutions.
The hypothesis is that erectile dysfunction is a preliminary condition of an upcoming cardiac event.
Myocardial infarction causes significant changes in erectile function in a natural survey.
The syntax score has a direct correlation with the baseline erectile function Residual syntax score has a direct relation with post-intervention erectile status.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients who undergo PCI due to a heart attack |
| Group 2 | – | –Patients who undergo PCI due to a stabile angina |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult male patients treated with percutaneous coronary intervention (PCI) for either acute myocardial infarction or stable angina at the Cardiology Department of Kırıkkale University Hospital. Eligible participants will be recruited consecutively after successful PCI and clinical stabilization. The study represents a hospital-based, observational cohort reflecting the typical male population undergoing PCI in a tertiary referral center. All assessments and follow-up visits will be conducted within the same institution's cardiology and urology outpatient clinics.
Key inclusion criteria (33 listed)
- Male patients aged 30-75 years
- Undergoing successful percutaneous coronary intervention (PCI) for one of the following:
- Hemodynamically stable after the PCI procedure
- Survival of the index hospitalization
- Ability to provide written informed consent
Key exclusion criteria (0 listed)
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
Change in erectile function score after percutaneous coronary intervention (PCI)
Time frame: Baseline (post-recovery from PCI) to 6 months follow-up]
Description: Erectile function will be assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire. The primary outcome is the change in mean IIEF-5 score from baseline to 6 months after PCI, comparing patients with myocardial infarction (Group 1) and those with stable angina (Group 2). A decrease in IIEF-5 score indicates worsening erectile function.
3 secondary outcomes
Effect of myocardial infarction on post-PCI erectile function
Time frame: Baseline (post-PCI recovery) and 6 months after PCI
Effect of myocardial infarction on post-PCI erectile function
Time frame: Baseline (post-PCI recovery) and 6 months after PCI
Association between fear symptoms and post-PCI erectile function Fear symptoms will be assessed using the Beck Depression Inventory (BDI), and their association with erectile function measured by the IIEF-5 will be examined.
Time frame: Baseline, 3 months, and 6 months after PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Results publication: PubMed 28697641Dostalova G, Hlubocka Z, Bayerova K, Belohlavek J, Linhart A, Karetova D. Erectile Dysfunction in Young Myocardial Infarction Survivors: Evaluation, Follow Up. Am J Mens Health. 2017 Nov;11(6):1739-1744. doi: 10.1177/1557988317714359. Epub 2017 Jul 11.
- Results publication: PubMed 30589239Hodzic E, Durek A, Begic E, Sabanovic Bajramovic N. Effect of myocardial infarction on the occurrence of erectile dysfunction. Med Glas (Zenica). 2019 Feb 1;16(1):35-39. doi: 10.17392/981-19.
- Results publication: PubMed 33224004Adam A, McDowall J, Aigbodion SJ, Enyuma C, Buchanan S, Vachiat A, Sheahan J, Laher AE. Is the History of Erectile Dysfunction a Reliable Risk Factor for New Onset Acute Myocardial Infarction? A Systematic Review and Meta-Analysis. Curr Urol. 2020 Oct;14(3):122-129. doi: 10.1159/000499249. Epub 2020 Oct 13.
- Results publication: PubMed 39027197Clarke ST, Le Grande M, Murphy BM, Hester R, Jackson AC. Protocol for the development and validation of a clinical measurement tool for fear of disease progression and recurrence in cardiac patients. Chronic Dis Transl Med. 2024 Jan 24;10(3):195-204. doi: 10.1002/cdt3.115. eCollection 2024 Sep.
- Results publication: PubMed 15538397Vacanti L, Caramelli B. Distress: associated variables of erectile dysfunction post-acute myocardial infarction. A pilot study. Int J Impot Res. 2005 Mar-Apr;17(2):204-6. doi: 10.1038/sj.ijir.3901274.
- Results publication: PubMed 16901623Montorsi P, Ravagnani PM, Galli S, Salonia A, Briganti A, Werba JP, Montorsi F. Association between erectile dysfunction and coronary artery disease: Matching the right target with the right test in the right patient. Eur Urol. 2006 Oct;50(4):721-31. doi: 10.1016/j.eururo.2006.07.015. Epub 2006 Jul 28.
- Results publication: PubMed 18703470Weintraub WS, Spertus JA, Kolm P, Maron DJ, Zhang Z, Jurkovitz C, Zhang W, Hartigan PM, Lewis C, Veledar E, Bowen J, Dunbar SB, Deaton C, Kaufman S, O'Rourke RA, Goeree R, Barnett PG, Teo KK, Boden WE; COURAGE Trial Research Group; Mancini GB. Effect of PCI on quality of life in patients with stable coronary disease. N Engl J Med. 2008 Aug 14;359(7):677-87. doi: 10.1056/NEJMoa072771.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy considerations.
Related trials for Erectile Disfunction
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Assessment of Effectiveness of Pelvic Floor Muscle Training With Biofeedback in Male With Hypogonadism and Erectile Dysfunction
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TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men
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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.
Timucin Sipal, Assistan Prof principal investigator
Kirikkale Univerity faculty of medicine department of Urology
Caglar Alp, Assistant Prof study director
Kirikkale Univerity Faculty of Medicine department of Cardiology
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 Erectile Disfunction and Coronary Artery Disease (CAD), run by Kırıkkale University at 1 site in Turkey (Türkiye).
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 33 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timucin Sipal, MD, PhD (+905338170659, drtimucin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in erectile function score after percutaneous coronary intervention (PCI) (time frame: Baseline (post-recovery from PCI) to 6 months follow-up]). 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 NCT07444697, which also lists 7 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 3 Mar 2026.