Menopause Clinical Trial
Official title:
Age at Menopause and Severity of Coronary Artery Disease Among Postmenopausal Women With Acute Coronary Syndromes
The Ladies ACS study will investigate the relation between age at menopause and severity of coronary artery disease in menopausal women with acute coronary syndromes and clinical indication to coronary angiography.
Multicenter prospective study in consecutive patients hospitalized with a wide spectrum of
ACS and clinical indication to coronary angiography.
Consecutive patients older than 55 years with an ACS undergoing coronary angiography are
eligible for the study, irrespective of subsequent revascularization. Eligible are women and
men with a 2:1 enrolment ratio.
Patients will be stratified according to gender and age, including four age categories:
55-64, 65-74, 75-85 and >85 years. Each age category will include 200 patients, and
enrolment in each category will be stopped once this number has been reached.
A specific electronic web-based CRF will collect clinical and procedural data. Clinical data
input will take place at the participating Centers. Angiographic data input will be
performed at rthe angiographic corelab, blinded of clinical data.
The e-CRF will collect data on
- the characteristics of the ACS
- the relevant risk factors for CAD and known prognostically relevant variables
- prior clinical history (prior MI, PCI, CABG, heart failure, stroke)
- in women fertility history will be captured by specific items, including age at first
and last menstrual period, past use of oral contraceptives, ongoing and past hormone
replacement therapy (HRT) and whether they had undergone a hysterectomy and/or
oophorectomy, as well as information on the number of full-term pregnancies (the sum of
live births and stillbirths). Age at menarche is defined as the age at the first
menstrual period. Reproductive life span is automatically calculated calculated by
subtracting the age at menarche from the age at menopause. The presence of hot flushes,
their severity and duration in years will be also captured.
The extent of coronary artery disease will be evaluated at a central corelab using the
Gensini score and the SYNTAX score
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04553029 -
A Survey Evaluating Prevalence, Severity and Associated Factors in East Asian Women With Moderate-to-severe Menopause-related Vasomotor Symptoms (MR-VMS)
|
||
| Completed |
NCT03672513 -
Short-term Supplementation, Bone Turnover and Antioxidant Status in Menopause
|
N/A | |
| Terminated |
NCT03642119 -
Validation of an Objective Instrument to Measure Hot Flashes During Menopause
|
||
| Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
| Completed |
NCT04210583 -
RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity
|
N/A | |
| Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
| Completed |
NCT05617287 -
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause
|
N/A | |
| Recruiting |
NCT05180266 -
Therapeutic Touch and Music in The Menopausal Period
|
N/A | |
| Recruiting |
NCT04043520 -
Bioenergetic Effects of Aging and Menopause (BEAM)
|
Phase 4 | |
| Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
| Completed |
NCT03363997 -
Pharmacokinetics and Pharmacodynamics of 3 Dosages of Estriol After Continuous Vaginal Administration for 21 Days
|
Phase 1 | |
| Not yet recruiting |
NCT04728126 -
Menopausal Symptoms and Burnout: Comparison of Occupational Health Issue Among Health Professionals in UMC Hospitals
|
||
| Not yet recruiting |
NCT04724135 -
Assessment of Menopause Related Quality of Life Among Health Professionals in University Hospitals of UMC in Nur-Sultan
|
||
| Completed |
NCT02274571 -
Raising Insulin Sensitivity in Post Menopause
|
Early Phase 1 | |
| Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
| Completed |
NCT02253173 -
Estradiol Vaginal Softgel Capsules in Treating Symptoms of Vulvar and Vaginal Atrophy in Postmenopausal Women
|
Phase 3 | |
| Completed |
NCT01757340 -
Calorie Restriction With Leucine Supplementation
|
N/A | |
| Recruiting |
NCT01488903 -
A Cohort Research of Genetic Susceptibility for Common Obesity in Women
|
N/A | |
| Terminated |
NCT01633814 -
Hormone Replacement and Neural Cardiovascular Control in Postmenopausal Women
|
N/A | |
| Completed |
NCT00599456 -
Investigation of the Usefulness of Omega 3 Vitamins in the Relief of Hot Flashes in Menopausal Women.
|
N/A |