Coronary Arterial Disease (CAD)NCT07010913
Erectile Dysfunction Progression After Percutaneous Coronary Angiography: Is Residual SYNTAX Score a Predictive Marker
An observational study of Coronary Arterial Disease (CAD) and Erectile Dysfunction, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Participant Information Sheet Dear Participant, Investigators would like to invite participants to participate in a research study and explain what it involves. Please take a few moments to read the following information carefully. If you have any questions, feel free to ask us at any time. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Coronary Arterial Disease (CAD), Erectile Dysfunction
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2025to Oct 2025
- 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 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male participants who have a heart attack and undergo percutaneous coronary intervention in our institutions and survive the event.
Who may be able to join
- Having a First heart attack
Who cannot join
- History of previous coronary intervention
- Neurological condition
- Previous pelvic surgery
- Aged less than 20 and more than 70 years
- Having an additional heart attack during the follow-up period
- Excluding from the study
- Having no sexual life
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
kirikkale Un'versity medical faculty
Kirikkale, 71500
About this study
Official title: Erectile Dysfunction Progression After Coronary Angiography: Is Residual SYNTAX Score a Predictive Marker
Participant Information Sheet Dear Participant,
Investigators would like to invite participants to participate in a research study and explain what it involves. Please take a few moments to read the following information carefully. If you have any questions, feel free to ask us at any time.
Read more
What is this study about? This study aims to understand how coronary angiography (a heart procedure you've recently had) may affect erectile function over time. Investigators are especially interested in whether the degree of blockage in participants' heart vessels and how well participants were treated during the procedure affect erectile health.
What will participants be asked to do?
If participants agree to take part:
Investigators will ask participants to answer a short questionnaire with five questions about their erectile function. This will happen once while participants recover in the hospital and again 6 months later.
Each question is rated on a simple scale from 0 to 5.
Investigators will also collect some medical information, such as your age, weight, height, blood test results, details about your heart condition, other health problems, and the medications participants are taking.
All information will be kept confidential and used only for scientific purposes. Participants' identities will not be revealed in any part of the study.
Do participants have to take part? No. Participation is completely voluntary. Participants can choose not to take part, and you can also stop at any time without giving a reason. Participants' decisions will not affect their medical care in any way.
Will there be any extra tests or costs? No. This study does not involve extra tests beyond regular medical care, such as blood tests or heart monitoring, and participation is free.
How long will the study last? The study will last approximately one year. Once it's completed, participants are welcome to ask for the results from our institution.
Who is conducting the study?
The study is being conducted by:
Assist Prof Dr. Timucin Sipal (Urology Department)
Assist Prof Dr. Caglar Alp (Cardiology Department)
You can contact them anytime using the phone number we have provided.
What happens next? If participants are happy to participate, please sign the attached consent form.
Sincerely, The Research Team
- Keywords
- syntax score, residual syntax score, erectile disfunction
- Medical subject headings
- Erectile Dysfunction
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 |
|---|---|---|
| Residual Syntax score more than 20% | Not described | |
| Residual Syntax score less than and equal 20% | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile functioning changes following percutaneous coronary intervention from baseline through 6 months
Participants' answers will decrease or increase from the baseline score of 0 to 25 on the IIEF questionnaires following percutaneous coronary intervention after a heart attack.
Measured: from February 2025 to September 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start14 Feb 2025
- Primary completion15 Sep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010913
- Sponsor's protocol ID
- 2025.01.13
- Status last verified
- Jun 2025
- First submitted
- 30 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erectile Dysfunction Progression After Coronary Angiography: Is Residual SYNTAX Score a Predictive Marker
- ClinicalTrials.gov ID
- NCT07010913
- Acronym / sponsor ID
- 2025.01.13
- Keywords
- syntax score, residual syntax score, erectile disfunction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 8 Jun 2025 (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.
Participant Information Sheet Dear Participant,
Investigators would like to invite participants to participate in a research study and explain what it involves. Please take a few moments to read the following information carefully. If you have any questions, feel free to ask us at any time.
What is this study about? This study aims to understand how coronary angiography (a heart procedure you've recently had) may affect erectile function over time. Investigators are especially interested in whether the degree of blockage in participants' heart vessels and how well participants were treated during the procedure affect erectile health.
What will participants be asked to do?
If participants agree to take part:
Investigators will ask participants to answer a short questionnaire with five questions about their erectile function. This will happen once while participants recover in the hospital and again 6 months later.
Each question is rated on a simple scale from 0 to 5.
Investigators will also collect some medical information, such as your age, weight, height, blood test results, details about your heart condition, other health problems, and the medications participants are taking.
All information will be kept confidential and used only for scientific purposes. Participants' identities will not be revealed in any part of the study.
Do participants have to take part? No. Participation is completely voluntary. Participants can choose not to take part, and you can also stop at any time without giving a reason. Participants' decisions will not affect their medical care in any way.
Will there be any extra tests or costs? No. This study does not involve extra tests beyond regular medical care, such as blood tests or heart monitoring, and participation is free.
How long will the study last? The study will last approximately one year. Once it's completed, participants are welcome to ask for the results from our institution.
Who is conducting the study?
The study is being conducted by:
Assist Prof Dr. Timucin Sipal (Urology Department)
Assist Prof Dr. Caglar Alp (Cardiology Department)
You can contact them anytime using the phone number we have provided.
What happens next? If participants are happy to participate, please sign the attached consent form.
Sincerely, The Research Team
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Residual Syntax score more than 20% | – | – |
| Residual Syntax score less than and equal 20% | – | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male participants who have a heart attack and undergo percutaneous coronary intervention in our institutions and survive the event.
Key inclusion criteria (1 listed)
- Having a First heart attack
Key exclusion criteria (7 listed)
- History of previous coronary intervention
- Neurological condition
- Previous pelvic surgery
- Aged less than 20 and more than 70 years
- Having an additional heart attack during the follow-up period
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
Erectile functioning changes following percutaneous coronary intervention from baseline through 6 months
Time frame: from February 2025 to September 2025
Participants' answers will decrease or increase from the baseline score of 0 to 25 on the IIEF questionnaires following percutaneous coronary intervention after a heart attack.
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 13 Jun 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Arterial Disease (CAD) and Erectile Dysfunction, 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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. 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?
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?
Erectile functioning changes following percutaneous coronary intervention from baseline through 6 months (time frame: from February 2025 to September 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.