- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07813195
Assessment of Erectile Dysfunction and Coronary Artery Disease Severity (BA-EDCAD)
Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease Severity, Prevalence and Clinical Correlation
연구 개요
상태
상세 설명
Erectile dysfunction (ED) and coronary artery disease (CAD) share a common pathophysiological substrate predominantly driven by systemic endothelial dysfunction, vascular inflammation, and atherosclerosis. Under the "artery size hypothesis," atherosclerotic plaque accumulation leads to clinical symptoms earlier in smaller vessels than in larger ones. Because penile cavernosal arteries are smaller in diameter (1-2 mm) compared to the proximal left anterior descending coronary artery (3-4 mm), lumen obstruction typically manifests as erectile impairment before overt coronary symptoms surface.
Consequently, assessing erectile health provides a critical non-invasive window into systemic vascular disease and serves as an early clinical marker for cardiovascular risk stratification. The 2021 European Society of Cardiology (ESC) Guidelines on cardiovascular disease prevention explicitly mandate evaluating organic ED as an independent risk modifier for silent cardiovascular disease.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ibrahim Atta Ibrahim, Master degree
- 전화번호: +201289193374
- 이메일: attai6866@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
The study population consists of male patients aged 18 to 50 years who present with erectile dysfunction secondary to diabetes mellitus or cardiovascular-related etiology, undergoing clinical evaluation and sexual health assessment in an outpatient setting.
Participants are drawn from eligible patients presenting for routine or specialized cardiovascular and medical care who meet the predefined age and clinical eligibility criteria. The population excludes individuals with primary psychogenic, endocrinological (excluding diabetes mellitus), or neurogenic erectile dysfunction, as well as those with severe systemic comorbidities including cardiogenic shock, hemodynamically unstable cardiovascular disease, NYHA Class III or IV decompensated heart failure, severe hepatic failure, end-stage renal disease on dialysis, active malignancies, or prior history of pelvic trauma/radical prostatectomy.
설명
Inclusion Criteria:
1 - Male patients aged between 18 and 50 years. 2-Patients undergoing primary or diagnostic coronary angiography due to suspected or confirmed acute, chronic coronary syndrome or stable angina.
3-Patients providing written informed consent to participate in the study and discuss sexual health assessments.
Exclusion Criteria:
- Patients presenting with cardiogenic shock, unstable hemodynamics.
- Primary psychogenic, endocrinological (except diabetes mellitus), or neurogenic erectile dysfunction.
- Prior history of pelvic surgery, pelvic trauma, or radical prostatectomy.
- Severe hepatic failure, end-stage renal disease on dialysis, or active malignancies.
- Decompensated heart failure (NYHA Class III or IV).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Coronary Artery Disease (CAD) Cohort
Male patients aged 18-50 undergoing diagnostic or primary coronary angiography for suspected or confirmed acute or chronic coronary syndromes.
Patients are evaluated for erectile dysfunction prevalence and severity using the Arabic-validated IIEF-5 questionnaire, with those showing severe ED undergoing pharmaco-penile duplex ultrasonography.
|
Diagnostic invasive coronary angiography performed to evaluate coronary anatomy, presence of stenosis, and anatomical severity scores (SYNTAX Score and Gensini Score).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
기간: Baseline
|
To determine the prevalence and clinical severity of erectile dysfunction (using the International Index of Erectile Function-5, IIEF-5) in patients diagnosed with coronary artery disease undergoing coronary angiography, and conversely, to assess the prevalence and anatomical severity of CAD in patients presenting with vasculogenic severe ED.
|
Baseline
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bidirectional Assessment of Erectile Dysfunction and Coronary Artery Disease: Prevalence, Severity, and Clinical Correlation
기간: Baseline
|
To correlate the severity of ED (IIEF-5 score) with the anatomical complexity and severity of CAD evaluated by coronary angiography (using the SYNTAX score or Gensini score). To evaluate echocardiographic parameters (e.g., left ventricular ejection fract |
Baseline
|
공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
- Gandaglia, G., Briganti, A., Jackson, G., Kloner, R. A., Montorsi, F., Montorsi, P., & Vlachopoulos, C. (2014). A systematic review of the association between erectile dysfunction and cardiovascular disease. European Urology, 65(5), 968-978
- Montorsi, P., Ravagnani, P. M., Galli, S., Rotatori, F., Veglia, F., Briganti, A., & Montorsi, F. (2006). Association between erectile dysfunction and coronary artery disease: matching the right patient with the right test. European Urology, 50(4), 721-7
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Association between ED and CAD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .