The LADIES Acute Coronary Syndromes Study (Ladies ACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Arcispedale Santa Maria Nuova-IRCCS
Sponsor:
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier:
NCT01997307
First received: September 14, 2013
Last updated: April 24, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: No ]
    The primary study end-point will be the severity of coronary artery disease, as appraised by the Gensini score


Estimated Enrollment: 800
Study Start Date: April 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997307

Contacts
Contact: Stefano Savonitto, MD +39-0341-489490 s.savonitto@ospedale.lecco.it
Contact: Francesco Prati, MD fprati61@gmail.com

Locations
Italy
Arcispedale Santa Maria Nuova- IRCCS Recruiting
Reggio Emilia, Italy, 42123
Contact: Stefano Savonitto, MD    +39-0341-489490    s.savonitto@ospedale.lecco.it   
Principal Investigator: Giovanni Tortorella, MD         
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

No publications provided

Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT01997307     History of Changes
Other Study ID Numbers: 117/2013
Study First Received: September 14, 2013
Last Updated: April 24, 2014
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Coronary Artery Disease
Acute Coronary Syndrome
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014