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
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Observational Model: Case Control, Time Perspective: Prospective
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