Coronary Acute SyndromeCASSANDRENCT01394549
Causes, Analysis of the Sub-evaluating Coronary Syndromes Acute and Disparities in France in Women
An observational study of Coronary Acute Syndrome, run by French Cardiology Society at 1 site in France.
Trial summary
Despite efforts of learned societies, community cardiology and more generally of most players in the health, cardiovascular diseases continue to be the leading cause of death among women in France and all over the Western world, there where they fell to second place among men. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Acute Syndrome
- How many people
- 319 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Mar 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be conducted in cardiac services regardless of the type of hospital where they are
Who may be able to join
- Women all patients and / or men regardless of age
- Admitted to a cardiology department (in the intensive care unit or cardiology traditional) week of the survey,
- Having presented an acute coronary syndrome, regardless of the type with or without ST segment above, with or without elevated troponin, complicated or not, regardless of its support invasive or conservative,
- Patients who agreed to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Despite efforts of learned societies, community cardiology and more generally of most players in the health, cardiovascular diseases continue to be the leading cause of death among women in France and all over the Western world, there where they fell to second place among men. Clinical practice and the disparity between the sexes are still insufficiently known.
Multicenter observational study on a cross-week comparative basis with men
Read the detailed description
In France, as in other industrialized countries, ischemic heart disease is a major cause of morbidity and mortality in women. Work to improve epidemiological knowledge, prevention, screening, risk stratification and treatment of ischemic heart disease in women has a potential impact on all the issues listed.
There is therefore a double challenge:
- A public health issue to alert the female population on cardiovascular risk and its consequences, while the female population does not feel concerned by the potential danger.
- A challenge for health professionals so that they have the same thing vis-à-vis the cardiovascular prevention among women and whatever their field of practice.
- Conditions
- Coronary Acute Syndrome
- 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 |
|---|---|---|
| Cardiology | The study includes all patients hospitalized for acute coronary syndrome during the week selected and who agreed to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical practices
To assess clinical practices and disparities between men and women in the management of acute coronary syndrome
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 posted14 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Acute SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephane MANZO-SILBERMAN, French Cardiology Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394549
- Sponsor's protocol ID
- 11320
- Acronym
- CASSANDRE
- Status last verified
- Aug 2019
- First submitted
- 13 Jul 2011
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available.
PubMed 20019324Stramba-Badiale M, Fox KM, Priori SG, Collins P, Daly C, Graham I, Jonsson B, Schenck-Gustafsson K, Tendera M. Cardiovascular diseases in women: a statement from the policy conference of the European Society of Cardiology. Eur Heart J. 2006 Apr;27(8):994-1005. doi: 10.1093/eurheartj/ehi819. Epub 2006 Mar 7.
PubMed 16522654Bairey Merz CN, Shaw LJ, Reis SE, Bittner V, Kelsey SF, Olson M, Johnson BD, Pepine CJ, Mankad S, Sharaf BL, Rogers WJ, Pohost GM, Lerman A, Quyyumi AA, Sopko G; WISE Investigators. Insights from the NHLBI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study: Part II: gender differences in presentation, diagnosis, and outcome with regard to gender-based pathophysiology of atherosclerosis and macrovascular and microvascular coronary disease. J Am Coll Cardiol. 2006 Feb 7;47(3 Suppl):S21-9. doi: 10.1016/j.jacc.2004.12.084.
PubMed 16458167Lerner DJ, Kannel WB. Patterns of coronary heart disease morbidity and mortality in the sexes: a 26-year follow-up of the Framingham population. Am Heart J. 1986 Feb;111(2):383-90. doi: 10.1016/0002-8703(86)90155-9.
PubMed 3946178Michos ED, Nasir K, Braunstein JB, Rumberger JA, Budoff MJ, Post WS, Blumenthal RS. Framingham risk equation underestimates subclinical atherosclerosis risk in asymptomatic women. Atherosclerosis. 2006 Jan;184(1):201-6. doi: 10.1016/j.atherosclerosis.2005.04.004.
PubMed 15907856Kwok Y, Kim C, Grady D, Segal M, Redberg R. Meta-analysis of exercise testing to detect coronary artery disease in women. Am J Cardiol. 1999 Mar 1;83(5):660-6. doi: 10.1016/s0002-9149(98)00963-1.
PubMed 10080415Mieres JH, Shaw LJ, Arai A, Budoff MJ, Flamm SD, Hundley WG, Marwick TH, Mosca L, Patel AR, Quinones MA, Redberg RF, Taubert KA, Taylor AJ, Thomas GS, Wenger NK; Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease: Consensus statement from the Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Circulation. 2005 Feb 8;111(5):682-96. doi: 10.1161/01.CIR.0000155233.67287.60. Epub 2005 Feb 1.
PubMed 15687114Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. doi: 10.1161/CIRCULATIONAHA.107.688101. No abstract available.
PubMed 17846343Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, Pollack C, Gibler WB, Ohman EM, Peterson ED; CRUSADE Investigators. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes. JAMA. 2005 Dec 28;294(24):3108-16. doi: 10.1001/jama.294.24.3108.
PubMed 16380591
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes, Analysis of the Sub-evaluating Coronary Syndromes Acute and Disparities in France in Women
- ClinicalTrials.gov ID
- NCT01394549
- Acronym / sponsor ID
- CASSANDRE / 11320
- Conditions
- Coronary Acute Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Jul 2011 (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.
Despite efforts of learned societies, community cardiology and more generally of most players in the health, cardiovascular diseases continue to be the leading cause of death among women in France and all over the Western world, there where they fell to second place among men. Clinical practice and the disparity between the sexes are still insufficiently known.
Multicenter observational study on a cross-week comparative basis with men
Detailed description
In France, as in other industrialized countries, ischemic heart disease is a major cause of morbidity and mortality in women. Work to improve epidemiological knowledge, prevention, screening, risk stratification and treatment of ischemic heart disease in women has a potential impact on all the issues listed.
There is therefore a double challenge:
- A public health issue to alert the female population on cardiovascular risk and its consequences, while the female population does not feel concerned by the potential danger.
- A challenge for health professionals so that they have the same thing vis-à-vis the cardiovascular prevention among women and whatever their field of practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiology | – | –The study includes all patients hospitalized for acute coronary syndrome during the week selected and who agreed to participate in the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted in cardiac services regardless of the type of hospital where they are
Key inclusion criteria (4 listed)
- Women all patients and / or men regardless of age
- Admitted to a cardiology department (in the intensive care unit or cardiology traditional) week of the survey,
- Having presented an acute coronary syndrome, regardless of the type with or without ST segment above, with or without elevated troponin, complicated or not, regardless of its support invasive or conservative,
- Patients who agreed to participate in the study.
Key exclusion criteria (0 listed)
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
Clinical practices
Time frame: 1 day
To assess clinical practices and disparities between men and women in the management of acute coronary syndrome
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 14 Aug 2019.
- Background: PubMed 20019324WRITING GROUP MEMBERS; Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Roger VL, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):e46-e215. doi: 10.1161/CIRCULATIONAHA.109.192667. Epub 2009 Dec 17. No abstract available.
- Background: PubMed 16522654Stramba-Badiale M, Fox KM, Priori SG, Collins P, Daly C, Graham I, Jonsson B, Schenck-Gustafsson K, Tendera M. Cardiovascular diseases in women: a statement from the policy conference of the European Society of Cardiology. Eur Heart J. 2006 Apr;27(8):994-1005. doi: 10.1093/eurheartj/ehi819. Epub 2006 Mar 7.
- Background: PubMed 16458167Bairey Merz CN, Shaw LJ, Reis SE, Bittner V, Kelsey SF, Olson M, Johnson BD, Pepine CJ, Mankad S, Sharaf BL, Rogers WJ, Pohost GM, Lerman A, Quyyumi AA, Sopko G; WISE Investigators. Insights from the NHLBI-Sponsored Women's Ischemia Syndrome Evaluation (WISE) Study: Part II: gender differences in presentation, diagnosis, and outcome with regard to gender-based pathophysiology of atherosclerosis and macrovascular and microvascular coronary disease. J Am Coll Cardiol. 2006 Feb 7;47(3 Suppl):S21-9. doi: 10.1016/j.jacc.2004.12.084.
- Background: PubMed 3946178Lerner DJ, Kannel WB. Patterns of coronary heart disease morbidity and mortality in the sexes: a 26-year follow-up of the Framingham population. Am Heart J. 1986 Feb;111(2):383-90. doi: 10.1016/0002-8703(86)90155-9.
- Background: PubMed 15907856Michos ED, Nasir K, Braunstein JB, Rumberger JA, Budoff MJ, Post WS, Blumenthal RS. Framingham risk equation underestimates subclinical atherosclerosis risk in asymptomatic women. Atherosclerosis. 2006 Jan;184(1):201-6. doi: 10.1016/j.atherosclerosis.2005.04.004.
- Background: PubMed 10080415Kwok Y, Kim C, Grady D, Segal M, Redberg R. Meta-analysis of exercise testing to detect coronary artery disease in women. Am J Cardiol. 1999 Mar 1;83(5):660-6. doi: 10.1016/s0002-9149(98)00963-1.
- Background: PubMed 15687114Mieres JH, Shaw LJ, Arai A, Budoff MJ, Flamm SD, Hundley WG, Marwick TH, Mosca L, Patel AR, Quinones MA, Redberg RF, Taubert KA, Taylor AJ, Thomas GS, Wenger NK; Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Role of noninvasive testing in the clinical evaluation of women with suspected coronary artery disease: Consensus statement from the Cardiac Imaging Committee, Council on Clinical Cardiology, and the Cardiovascular Imaging and Intervention Committee, Council on Cardiovascular Radiology and Intervention, American Heart Association. Circulation. 2005 Feb 8;111(5):682-96. doi: 10.1161/01.CIR.0000155233.67287.60. Epub 2005 Feb 1.
- Background: PubMed 17846343Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. doi: 10.1161/CIRCULATIONAHA.107.688101. No abstract available.
- Background: PubMed 16380591Alexander KP, Chen AY, Roe MT, Newby LK, Gibson CM, Allen-LaPointe NM, Pollack C, Gibler WB, Ohman EM, Peterson ED; CRUSADE Investigators. Excess dosing of antiplatelet and antithrombin agents in the treatment of non-ST-segment elevation acute coronary syndromes. JAMA. 2005 Dec 28;294(24):3108-16. doi: 10.1001/jama.294.24.3108.
Related trials for Coronary Acute Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Acute Syndrome, run by French Cardiology Society 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 4 inclusion and 0 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 14 Aug 2019. 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?
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?
Clinical practices (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 NCT01394549, which also lists 9 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 14 Aug 2019.