The LADIES Acute Coronary Syndromes Study (Ladies ACS)
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.
Acute Coronary Syndromes
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Age at Menopause and Severity of Coronary Artery Disease Among Postmenopausal Women With Acute Coronary Syndromes|
- Extent of coronary artery disease at angio corelab (Gensini and SYNTAX score) [ Time Frame: 1 day ] [ Designated as safety issue: No ]The primary study end-point will be the severity of coronary artery disease, as appraised by the Gensini score
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Stratification by gender and age, including 4 age categories
|Age >=65 to 74|
|Age >=75 to 84|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01997307
|Contact: Stefano Savonitto, MDemail@example.com|
|Contact: Francesco Prati, MDfirstname.lastname@example.org|
|Arcispedale Santa Maria Nuova- IRCCS||Recruiting|
|Reggio Emilia, Italy, 42123|
|Contact: Stefano Savonitto, MD +39-0341-489490 email@example.com|
|Principal Investigator: Giovanni Tortorella, MD|
|Study Chair:||Stefano Savonitto, MD||Division of Cardiology, Manzoni Hospital, Lecco|
|Principal Investigator:||Giovanni Tortorella, MD||Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia|