The LADIES Acute Coronary Syndromes Study

NCT01997307 | Completed DMC

• 1 other identifier: 117/2013
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndromes; Menopause

Keywords

acute coronary syndrome, coronary arteriography, menopause

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Stratification by gender and age, including 4 age categories

\>=55-64 years

Age >=65 to 74

Age >=75 to 84

Age >=85

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Arcispedale Santa Maria Nuova- IRCCS

Reggio Emilia, Italy, 42123, Italy

Location

Related Publications (2)

• 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.

  PMID: 29486998 DERIVED

• 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.

  PMID: 27321972 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Stefano Savonitto, MD

  Division of Cardiology, Manzoni Hospital, Lecco

  STUDY CHAIR

• Giovanni Tortorella, MD

  Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2013
• First Posted: November 28, 2013
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 24, 2025

Record last verified: 2015-12

Locations

IT (1)