Clinical trial NCT01997307: The LADIES Acute Coronary Syndromes Study
Official title: Age at Menopause and Severity of Coronary Artery Disease Among Postmenopausal Women With Acute Coronary Syndromes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndromes
Menopause
Keywords: acute coronary syndrome, coronary arteriography, menopause
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2013-11-28
Enrollment: 675
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients older than 55 years with an acute coronary syndromes, undergoing coronary angiography are eligible for the study, irrespective of subsequent revascularization. Eligible are women and men with a 2:1 enrolment ratio.

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

Patients \>55 years of age with all of the following characteristics:

* symptoms suggestive of acute myocardial ischemia within the previous 48 hours.
* The diagnosis of an ACS must be confirmed by a typical rise and fall in serum troponin levels as defined by the Third Universal Definition of Myocardial Infarction.
* ECG signs of myocardial ischemia defined as either transient or persistent ST segment elevation or depression \>0.5 mm (but \>1 mm in the case of ST-segment elevation), or persistent and definite T-wave inversion \>1 mm, including the pseudonormalization of a previously negative T-wave, in ≥2 contiguous leads.

Exclusion Criteria:

* none

Primary outcomes:
measure: Extent of coronary artery disease at angio corelab (Gensini and SYNTAX score)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova- IRCCS
Study officials:
affiliation: Division of Cardiology, Manzoni Hospital, Lecco
name: Stefano Savonitto, MD
role: STUDY_CHAIR
affiliation: Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia
name: Giovanni Tortorella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savonitto S, Morici N, Franco N, Misuraca L, Lenatti L, Ferri LA, Lo Jacono E, Leuzzi C, Corrada E, Aranzulla TC, Cagnacci A, Colombo D, La Vecchia C, Prati F; LADIES ACS Investigators. Age at menopause, extent of coronary artery disease and outcome among postmenopausal women with acute coronary syndromes. Int J Cardiol. 2018 May 15;259:8-13. doi: 10.1016/j.ijcard.2018.02.065. Epub 2018 Feb 21.
citation: Savonitto S, Colombo D, Franco N, Misuraca L, Lenatti L, Romano IJ, Morici N, Lo Jacono E, Leuzzi C, Corrada E, Aranzulla TC, Petronio AS, Bellia G, Romagnoli E, Cagnacci A, Zoccai GB, Prati F; LADIES ACS Study Investigators. Age at Menopause and Extent of Coronary Artery Disease Among Postmenopausal Women with Acute Coronary Syndromes. Am J Med. 2016 Nov;129(11):1205-1212. doi: 10.1016/j.amjmed.2016.05.031. Epub 2016 Jun 16.