Erectile Dysfunction Progression After Percutaneous Coronary Angiography: Is Residual SYNTAX Score a Predictive Marker

NCT07010913 | Active Not Recruiting

• 1 other identifier: 2025.01.13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Coronary Arterial Disease (CAD); Erectile Dysfunction

Keywords

syntax score; residual syntax score; erectile disfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  from February 2025 to September 2025

Study Arms (2)

Residual Syntax score more than 20%

Residual Syntax score less than and equal 20%

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: Male erectile disfunction study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male participants who have a heart attack and undergo percutaneous coronary intervention in our institutions and survive the event.

You may qualify if:

• Having a First heart attack

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

kirikkale Un'versity medical faculty

Kırıkkale, 71500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant Professor/ Lecturer

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 8, 2025
• Study Start: February 14, 2025
• Primary Completion: September 15, 2025
• Study Completion: October 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: approximately at the end of August 2025

Locations

TU (1)