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The LADIES Acute Coronary Syndromes Study (Ladies ACS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01997307
First Posted: November 28, 2013
Last Update Posted: December 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS
  Purpose
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.

Condition
Acute Coronary Syndromes Menopause

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Arcispedale Santa Maria Nuova-IRCCS:

Primary Outcome Measures:
  • Extent of coronary artery disease at angio corelab (Gensini and SYNTAX score) [ Time Frame: 1 day ]
    The primary study end-point will be the severity of coronary artery disease, as appraised by the Gensini score


Enrollment: 675
Study Start Date: April 2014
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stratification by gender and age, including 4 age categories
>=55-64 years
Age >=65 to 74
Age >=75 to 84
Age >=85

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997307


Locations
Italy
Arcispedale Santa Maria Nuova- IRCCS
Reggio Emilia, Italy, 42123
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
Investigators
Study Chair: Stefano Savonitto, MD Division of Cardiology, Manzoni Hospital, Lecco
Principal Investigator: Giovanni Tortorella, MD Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT01997307     History of Changes
Other Study ID Numbers: 117/2013
First Submitted: September 14, 2013
First Posted: November 28, 2013
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
acute coronary syndrome, coronary arteriography, menopause

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases