Echocardiography in Men With Erectile Dysfunction

NCT05285280 | Active Not Recruiting DMC

• 1 other identifier: EDcard
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease is the leading cause of morbidity and mortality in the world. To curb disease development, there is, therefore, a need to identify more people at increased risk. This can be done by advanced echocardiography, where the exact contraction pattern and dimensions of the heart are measured. One group of patients who are already considered to be at increased risk for later development of heart disease are men with erectile dysfunction. The investigators goal is to study the early detection of cardiac dysfunction in men with erectile dysfunction using both conventional and advanced echocardiography to analyze the possibility of preventing serious cardiovascular disease.

Conditions

Erectile Dysfunction; Cardiovascular Diseases; Cardiac Disease

Keywords

Echocardiography; 3D Echocardiography; Strain Rate Imaging; Tissue Doppler; Speckle Tracking

Outcome Measures

Primary Outcomes (21)

• Number of reported cardiac arrest through medical records

  1 year

• Number of reported cardiac arrest through medical records

  5 years

• Number of reported cardiac arrest through medical records

  10 years

• Number of reported hospital admission with heart failure through medical records

  1 year

• Number of reported hospital admission with heart failure through medical records

  5 years

• Number of reported hospital admission with heart failure through medical records

  10 years

• Number of reported peripheral artery disease through medical records

  Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).

  1 year

• Number of reported peripheral artery disease through medical records

  Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).

  5 years

• Number of reported peripheral artery disease through medical records

  Registration of: Cholesterol levels, blood pressure, claudication and ankle brachial index (ABI).

  10 years

• Number of reported coronary heart disease through medical records

  Registration of: Coronary angiography

  1 year

• Number of reported coronary heart disease through medical records

  Registration of: Coronary angiography

  5 years

• Number of reported coronary heart disease through medical records

  Registration of: Coronary angiography

  10 years

• Number of reported hospital admission with acute myocardial infarction through medical records

  1 year

• Number of reported hospital admission with acute myocardial infarction through medical records

  5 years

• Number of reported hospital admission with acute myocardial infarction through medical records

  10 years

• Number of reported angina pectoris through medical records

  1 year

• Number of reported angina pectoris through medical records

  5 years

• Number of reported angina pectoris through medical records

  10 years

• Number of reported ischemic heart disease through medical records

  1 year

• Number of reported ischemic heart disease through medical records

  5 years

• Number of reported ischemic heart disease through medical records

  10 years

Secondary Outcomes (3)

• Number of reported all cause mortality

  1 year

• Number of reported all cause mortality

  5 years

• Number of reported all cause mortality

  10 years

Interventions

Echocardiography DIAGNOSTIC_TEST

The echocardiography will be performed with a GE Vingmed Ultrasoundís Vivid9 (Horten, Norway). All subjects are examined with color TDI, 2-dimensional and M-mode echocardiography, conventional spectral Doppler, 2DSTE, and where possible 4D Echocardiography in the left lateral decubitus position.

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be invited from the Urology outpatient clinic at Gentofte Hospital.

You may not qualify if:

• Patients not able to cooperate
• Patients unable to understand and sign "informed consent"
• Previous pelvic surgery (including prostatectomy, cystectomy and rectal surgery)
• Neurological diseases (e.g. multiple sclerosis, spinal cord injury)
• ED following pelvic trauma

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Urological Research Unit

Herlev, Capital Region, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Erectile Dysfunction; Cardiovascular Diseases; Heart Diseases

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 17, 2022
• Study Start: March 1, 2022
• Primary Completion: January 5, 2024
• Study Completion (Estimated): March 1, 2032
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)