The LADIES Acute Coronary Syndromes Study (Ladies ACS)

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.

Study Overview

• Status: Completed
• Conditions: Menopause; Acute Coronary Syndromes

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

• Study Type: Observational
• Enrollment (Actual): 675

Contacts and Locations

Study Locations

• Italy
  • Reggio Emilia, Italy, 42123
    • Arcispedale Santa Maria Nuova- IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Stratification by gender and age, including 4 age categories; >=55-64 years
Age >=65 to 74
Age >=75 to 84
Age >=85

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 14, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: acute coronary syndrome, coronary arteriography, menopause
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: 117/2013