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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.
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 extent of coronary artery disease will be evaluated at a central corelab using the Gensini score and the SYNTAX score
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratification by gender and age, including 4 age categories | >=55-64 years | ||
| Age >=65 to 74 | |||
| Age >=75 to 84 | |||
| Age >=85 |
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| 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 |
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Inclusion Criteria:
Patients >55 years of age with all of the following characteristics:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Savonitto, MD | Division of Cardiology, Manzoni Hospital, Lecco | Study Chair |
| Giovanni Tortorella, MD | Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcispedale Santa Maria Nuova- IRCCS | Reggio Emilia | Italy | 42123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29486998 | Derived | 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. | |
| 27321972 |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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. |