PAOD - Peripheral Arterial Occlusive DiseaseAOMINCT05149456
Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care
An observational study of PAOD - Peripheral Arterial Occlusive Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The cardiovascular risk of women has been the subject of particular interest in recent years, in the world, in particular under the impetus of Cardiology companies, with more and more work focusing on the specificities of these diseases in women as well as differences in terms of management and prognosis with a… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- PAOD - Peripheral Arterial Occlusive Disease
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Aug 2021to 31 Aug 2022
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult woman hospitalized in an Intensive Cardiology Unit (ICU) at the HUS for a type 1 myocardial infarction confirmed according to the criteria of the fourth universal definition of the ESC between 01/01/2021 to 30/06/2021 inclusive
Who may be able to join
- Adult woman (≥18 years old)
- Patient hospitalized in an Intensive Cardiology Unit (ICU) at the HUS for a type 1 myocardial infarction confirmed according to the criteria of the fourth universal definition of the ESC between 01/01/2021 to 30/06/2021 inclusive
- Patient who did not express her opposition to the reuse of her data for scientific research purposes.
Who cannot join
- Patient who expressed her opposition to participating in the study
- Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, MMS <20/30…)
- Non-type 1 or unconfirmed myocardial infarction
- Unstable or refractory shock state at the time of the echodoppler examination
- Complication of the coronary angiography approach, in the case of femoral approach only, requiring surgical management.
- Patient under curatorship, guardianship or judicial safeguard.
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service des Maladies VASC-HTA-Pharmacologie Clinique - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Dominique STEPHAN, MD, PhD, 33 3 69 55 09 52, dominique.stephan@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Study of the Prevalence of Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care
The cardiovascular risk of women has been the subject of particular interest in recent years, in the world, in particular under the impetus of Cardiology companies, with more and more work focusing on the specificities of these diseases in women as well as differences in terms of management and prognosis with a literature mainly based on American data and which focuses particularly on ischemic heart disease.
The expected results are to have a prevalence of PAOD in an Alsatian cohort, most of the data we currently have from American data, with analysis of the impact of specific and non-specific risk factors in this cohort and their weight in PAOD.
- Keywords
- Peripheral Arterial Occlusive Disease, PAOD, Cardiovascular risk factors, Myocardial infarction
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the prevalence of peripheral artery occlusive disease (PAOD)
Measured: Files analysed retrospectively from January 01, 2021 to Jun 30, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Aug 2021
- Primary completionAug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAOD - Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique STEPHAN, MD, PhD, Principal investigator, Service des Maladies VASC-HTA-Pharmacologie Clinique - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149456
- Sponsor's protocol ID
- 8373
- Acronym
- AOMI
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Peripheral Artery Occlusive Disease (PAOD) in Women Hospitalized for Type 1 Myocardial Infarction in Intensive Cardiology Care
- ClinicalTrials.gov ID
- NCT05149456
- Acronym / sponsor ID
- AOMI / 8373
- Keywords
- Peripheral Arterial Occlusive Disease, PAOD, Cardiovascular risk factors, Myocardial infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- 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 cardiovascular risk of women has been the subject of particular interest in recent years, in the world, in particular under the impetus of Cardiology companies, with more and more work focusing on the specificities of these diseases in women as well as differences in terms of management and prognosis with a literature mainly based on American data and which focuses particularly on ischemic heart disease.
The expected results are to have a prevalence of PAOD in an Alsatian cohort, most of the data we currently have from American data, with analysis of the impact of specific and non-specific risk factors in this cohort and their weight in PAOD.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult woman hospitalized in an Intensive Cardiology Unit (ICU) at the HUS for a type 1 myocardial infarction confirmed according to the criteria of the fourth universal definition of the ESC between 01/01/2021 to 30/06/2021 inclusive
Key inclusion criteria (3 listed)
- Adult woman (≥18 years old)
- Patient hospitalized in an Intensive Cardiology Unit (ICU) at the HUS for a type 1 myocardial infarction confirmed according to the criteria of the fourth universal definition of the ESC between 01/01/2021 to 30/06/2021 inclusive
- Patient who did not express her opposition to the reuse of her data for scientific research purposes.
Key exclusion criteria (6 listed)
- Patient who expressed her opposition to participating in the study
- Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, MMS <20/30…)
- Non-type 1 or unconfirmed myocardial infarction
- Unstable or refractory shock state at the time of the echodoppler examination
- Complication of the coronary angiography approach, in the case of femoral approach only, requiring surgical management.
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
Study of the prevalence of peripheral artery occlusive disease (PAOD)
Time frame: Files analysed retrospectively from January 01, 2021 to Jun 30, 2021 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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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.
Saïd CHAYER, PhD, HDR contact
Dominique STEPHAN, MD, PhD principal investigator
Service des Maladies VASC-HTA-Pharmacologie Clinique - Hôpitaux Universitaires de Strasbourg
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 PAOD - Peripheral Arterial Occlusive Disease, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Dec 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique STEPHAN, MD, PhD (33 3 69 55 09 52, dominique.stephan@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the prevalence of peripheral artery occlusive disease (PAOD) (time frame: Files analysed retrospectively from January 01, 2021 to Jun 30, 2021 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2021.