Ignite Creation Date:
2024-05-06 @ 2:14 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01997307
Status:
COMPLETED
Last Update Posted:
2015-12-22
First Post:
2013-09-14
Brief Title:
The LADIES Acute Coronary Syndromes Study
Sponsor:
Arcispedale Santa Maria Nuova-IRCCS
Organization:
Arcispedale Santa Maria Nuova-IRCCS
Study Overview
Official Title:
Age at Menopause and Severity of Coronary Artery Disease Among Postmenopausal Women With Acute Coronary Syndromes
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Ladies ACS
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
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 21 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 andor 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
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 21 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None