The LADIES Acute Coronary Syndromes Study

Menopause Clinical Trial

— Ladies ACS  

Official title:

Age at Menopause and Severity of Coronary Artery Disease Among Postmenopausal Women With Acute Coronary Syndromes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997307
• Other study ID #: 117/2013
• Status: Completed
• Phase: N/A
• First received: September 14, 2013
• Last updated: December 21, 2015
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 675
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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:

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Menopause
• Syndrome

Locations

Country	Name	City	State
Italy	Arcispedale Santa Maria Nuova- IRCCS	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent of coronary artery disease at angio corelab (Gensini and SYNTAX score)	The primary study end-point will be the severity of coronary artery disease, as appraised by the Gensini score	1 day	No