Acute Coronary SyndromesLadies ACSNCT01997307
The LADIES Acute Coronary Syndromes Study
An observational study of Acute Coronary Syndromes and Menopause, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Coronary Syndromes, Menopause
- How many people
- 675 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Age at Menopause and Severity of Coronary Artery Disease Among Postmenopausal Women With Acute Coronary Syndromes
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.
Read the 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
- Conditions
- Acute Coronary Syndromes, Menopause
- Keywords
- acute coronary syndrome, coronary arteriography, menopause
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stratification by gender and age, including 4 age categories | >=55-64 years | |
| Age >=65 to 74 | Not described | |
| Age >=75 to 84 | Not described | |
| Age >=85 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stefano Savonitto, MD, Study chair, Division of Cardiology, Manzoni Hospital, LeccoGiovanni Tortorella, MD, Principal investigator, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997307
- Sponsor's protocol ID
- 117/2013
- Acronym
- Ladies ACS
- Status last verified
- Dec 2015
- First submitted
- 14 Sep 2013
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29486998Savonitto 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.
PubMed 27321972
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age at Menopause and Severity of Coronary Artery Disease Among Postmenopausal Women With Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT01997307
- Acronym / sponsor ID
- Ladies ACS / 117/2013
- Conditions
- Acute Coronary Syndromes, Menopause
- Keywords
- acute coronary syndrome, coronary arteriography, menopause
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stratification by gender and age, including 4 age categories | – | –>=55-64 years |
| Age >=65 to 74 | – | – |
| Age >=75 to 84 | – | – |
| Age >=85 | – | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Derived from this study: PubMed 29486998Savonitto 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.
- Derived from this study: PubMed 27321972Savonitto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Savonitto, MD study chair
Division of Cardiology, Manzoni Hospital, Lecco
Giovanni Tortorella, MD principal investigator
Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes and Menopause, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of coronary artery disease at angio corelab (Gensini and SYNTAX score) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01997307, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.